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Interventions for body weight reduction in obese patients during short consultations: an open-label randomized controlled trial in the Japanese primary care setting

Interventions for body weight reduction in obese patients during short consultations: an... Background: Family physicians should maintain regular contact with obese patients to ensure they effectively reduce their body weight. However, family physicians in Japan have on average only 6 (min) per consultation, and conventional interventions for body weight reduction require a longer consultation or additional manpower. A brief intervention within the limited consultation time available is therefore needed. Here we investigated the effectiveness of a brief weight reduction intervention for obese patients and the related factors for reducing body weight during routine consultations in the primary care setting. Method: We conducted an open-label randomized controlled trial at a family medicine clinic in Fukushima, Japan from January 2010 to June 2011. Patients aged 30 to 69 years with body mass index ≥25 who were diagnosed with hypertension, dyslipidemia, and/or type 2 diabetes mellitus were randomly assigned to the intervention or control group. At every consultation, body weight in the intervention group was measured by a family physician who provided weight reduction advice in addition to usual care. The primary outcome was body weight change at 1-year follow up. Analysis was done by intention to treat. Result: We randomly assigned 29 participants to the intervention group and 21 to the control group. Forty participants (80 %) remained in the trial until the 1-year follow up. At follow up, the median body weight change from baseline was not significantly different between the groups (p = 0.68), at −0.8 (interquartile range [IQR] −2.5 to 1.0) kg in the intervention group and 0.2 (IQR −2.4 to 0.8) kg in the control group. Conclusion: We devised an intervention method for physicians to measure body weight and advise on weight reduction during routine consultations. In our setting, this method did not extend the consultation time, but also had no significant additional effects on body weight reduction in moderately obese patients. Trial registration: This trial is registered with the UMIN Clinical Trial Registry (UMIN000002967). Keywords: Obesity, Weight reduction, Brief intervention, Primary care, Outpatient care, Short consultation Background million, and those with type 2 diabetes from 2.3 million The number of patients with hypertension, dyslipidemia, to 2.7 million [1]. All three of these diseases are related or type 2 diabetes mellitus has increased in the last few to obesity [2, 3]. In 2008, more than 10 % of the world’s decades in Japan [1]. From 2002 to 2011, the number of adult population was obese according to the World patients with hypertension increased from 7 million to 9 Health Organization’s definition of a body mass index million, those with dyslipidemia from 1.4 million to 1.9 (BMI) ≥30 kg/m [4], although only 3 % of the Japanese population in 2011 conformed to this definition of obes- ity [5]. As the incidence rates of obesity-related diseases * Correspondence: kanke@fmu.ac.jp Department of Community and Family Medicine, Fukushima Medical in Japan have been increasing, an international expert University, 1 Hikarigaoka, Fukushima City, Fukushima Prefecture, Japan panel proposed a lower BMI cut-off for the Japanese Full list of author information is available at the end of the article © 2015 Kanke et al.; licensee BioMed Central. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 2 of 12 population [6]. The current definition of obesity for reduction strategies consist of the following five approaches: Japanese is BMI ≥25 kg/m [7]. According to this definition, dietary intervention, physical activity, behavioral treatment, 30 % of Japanese adult men and 21 % of Japanese adult pharmacotherapy, and surgical therapy [3]. Many stud- women were reported to be obese in 2011 [5]. Developing ies in the primary care setting have reported the effects an effective intervention for reducing the body weight of of dietary intervention, physical activity, and pharmaco- obese Japanese patients has the potential to improve the therapy on body weight reduction in obese patients management of obesity-related diseases. [13–15]. However, weight monitoring is a component Although the guidelines for managing overweight and of behavioral treatment, and in the area of behavioral obesity recommend advising patients with obesity-related treatment, most studies on body weight reduction have diseases to lose weight [8], the weight reduction approach applied an intensive approach in an academic setting; of healthcare providers remains inadequate [9]. Primary few studies have reported the effects of behavioral treatment care physicians meet many obese patients with obesity- on body weight reduction in the primary care setting [22]. related diseases [10] and should maintain regular contact Against this background, we hypothesized that if phy- with thesepatientstoensuretheyreducetheir body sicians involved in outpatient care measure patient body weight as necessary. Epstein and Ogden revealed conflict- weight and advise on weight reduction at every consult- ing points of view between primary care physicians and ation, this approach might reduce the body weight of obese obese patients. Obese patients regarded obesity as a med- patients since it can be performed quickly and easily. There ical problem that should be managed by the physicians. In are several important points regarding the approach taken contrast, physicians consider obesity management to be in this study. First, obese patients should monitor their primarily the patient’s responsibility. One of the reasons weight with their physician since weight monitoring en- for this discord is the lack of effective patient interventions ables obese patients to recognize their actual condition. in the primary care setting [11]. In the primary care set- We planned weight monitoring with a physician at every ting, physicians need a brief and easy-to-perform inter- consultation to ensure a sense of urgency and motivation vention method for encouraging obese patients to lose for lifestyle change. Second, physicians should ask patients weight. Because physicians manage on average three about their lifestyles based on the measured body weight problems during each short consultation [12], it is too and provide specific advice on aspects that are difficult to difficult to provide the proven intervention methods improve. Third, an intervention method for lifestyle change established in other studies in a real-world clinical set- is needed to improve doctor-patient relationships [23, 24]. ting. In previous studies conducted in the primary care Fourth, we planned to establish a trust relationship by setting outside of Japan, patient body weight has been requesting the physician to advise on the intervention effectively reduced through lifestyle counseling provided method. The objective of this study, therefore, was to by medical assistants, nurses, or dietitians [13–15], as well devise a brief and easy-to-perform intervention method as by Internet-based intervention programs [16, 17]. In for body weight reduction in the Japanese primary care Japan, providing these interventions in the primary care setting. setting is difficult because very few dietitians work for pri- mary care clinics and clinic nurses do not have sufficient Methods experience in lifestyle counseling. In fact, most lifestyle Design and participants counseling is given by Japanese primary care physicians We planned an open-label randomized control study at during regular patient visits [18]. In other studies, physi- a family medicine clinic (Date City, Fukushima Prefecture, cians have provided tailored intervention to obese patients Japan) attended by four family physicians. Date city is lo- during 15 to 20-min long consultations [19, 20]; however, cated 250 km north of Tokyo, its population was about in Japan, primary care consultations last for around 6 min 66,000 people in 2010, and main industry of the city is [21], meaning that primary care physicians cannot practic- agriculture. From January to June 2010, we checked the ally provide any effective counseling-based interventions medical records of adult patients aged 30–69 years who due to time constraints. In the Japanese primary care set- visited the family medicine department for routine checkups ting, physicians need simple and easy-to-perform methods for hypertension, dyslipidemia, and/or type 2 diabetes of intervention that are suitable for use in routine brief mellitus. A total of 180 patients were matched in January consultations. 2010. From the pool, we recruited 57 patients with a In our clinical experience, some of our obese patients, BMI ≥25 kg/m (moderately to severely obese) to par- whose body weight was checked by the physician at every ticipate in this study. We excluded patients with a history consultation, managed to reduce their body weight. Based of cancer or psychological disease, or those prescribed hor- on this success, we focused on body weight monitoring mone therapy because these factors are known to affect as an innovative method for promoting body weight re- body weight [25–27]. We informed all participants of the duction in the primary care setting. In general, weight aim and content of the study, and obtained their written Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 3 of 12 consent to participate. After being informed of this research abdominal circumference, and blood pressure. After defe- project, 51 patients agreed to participate. One participant cating and urinating, participants removed their shoes and with a history of cancer was excluded. At baseline measure- wore as light clothing as possible for height and body ment, 50 participants (18 women, 36 %; 32 men, 64 %) were weight measurement on a digital scale. Abdominal circum- enrolled. We randomized 29 participants to the interven- ference was measured at the umbilical level with a tape tion group and 21 participants to the control group. In measure in the standing position and at end-expiratory total, 44 participants (88 %) were assessed for body weight pressure [28], and blood pressure was measured in the sit- changes at 6 months, and 40 participants (80 %) remained ting position with an automated sphygmomanometer after in the study until the 1-year follow up (Fig. 1). a few minutes rest. We checked these data and the partici- pants’ medical records to ensure the participants met the Baseline data and measurement criteria for metabolic syndrome (Japanese criteria and the After the participants agreed to participate, their physician National Cholesterol Education Program-Adult Treatment collected the following baseline data: age, sex, history of Panel III criteria) [28, 29]. hypertension (yes or no), history of dyslipidemia (yes or no), history of type 2 diabetes (yes or no), educational background (junior high school, high school, technical Randomization college, or university), history of smoking (never smoker, Participants were assigned original identification numbers, former smoker, or current smoker), history of alcohol which were sent to a co-researcher (AI) working at an- consumption (never drinker, <once a week, <3 times per other hospital who randomized these numbers into two week, <6 times per week, or daily), and frequency of body groups (intervention group and control group) by means weight self-monitoring (<once a month, <once a week, of a table of random numbers. The randomization results several times per week, or daily). were sent to the chief researcher (SK) who informed the Nurses, who were blinded to the group assignment of participants. Figure 1 shows the participant flow through- each patient, measured participant height, body weight, out the study. Patients aged 30-69 years old diagnosed as having hypertension, dyslipidemia, or type 2 diabetes mellitus (n=180) BMI <25 (n=123) (n=57) Excluded (n=4) Did not agree to participate (n=2) Screening and baseline measurement (n=51) Excluded (n=1) Enrolled and randomized (n=50) Intervention group Control group (n=29) (n=21) Loss of contact Loss of contact (n=3) (n=2) Excluded (n=1) Follow up at 6 Follow up at 6 months months (n=25) (n=19) Moving house (n=1) Loss of contact Loss of contact (n=1) (n=2) Follow up at 1 year Follow up at 1 year (n=22) (n=18) Fig. 1 Participant flow chart Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 4 of 12 Intervention Thereafter, participants received care for their current In the intervention group, at the first consultation after diseases based on the Japanese guidelines every 1 or 2 randomization, participants were informed about their months. However, the physician was not required to meas- ideal body weight, weight reduction target (5 % of current ure body weight or discuss body weight reduction at every weight), and the positive effect of weight reduction for consultation. their current diseases by the physician, who provided them with an information leaflet [30]. Participants were Outcomes also informed that a physician would check their body The primary outcome of this study was change in body weight and provide specific advice on weight reduction weight at 1-year follow up. Secondary outcomes were at every regular consultation. Thereafter, the participants changes in body weight at 6-month follow up, and changes received care for their current diseases based on the in abdominal circumference and blood pressure at the 6- Japanese guidelines for hypertension, dyslipidemia, and month and 1-year follow ups. Nurses blinded to the group type 2 diabetes [31–33] every 1 or 2 months. A physician assignment of each patient measured body weight, abdom- measured body weight after defecation and micturition inal circumference, and blood pressure at 6 months and 1 using an analogue scale at every consultation and provided year. The nurses then asked the participants about their advice in relation to the changes of measured body weight frequency of weight self-monitoring at the 1-year follow up at each consultation. In addition, at every consultation, using the same classification as that used at baseline. Physi- the physician was required to specifically question the pa- cians recorded the length (in minutes and seconds) of each tient on eating and exercise, to reconfirm the patient’s consultation and calculated the mean length for each weight target, and to provide advice focusing on each patient after all participants had completed the 1-year participant’s difficulties in lifestyle change. We requested follow up. all physicians to perform this intervention, even if the con- sultation duration exceeded the usual appointment time Sample size calculation (Table 1). We selected a mean weight difference of 2 kg after 1 In the control group, at the first consultation after year as clinically significant and assumed a standard de- randomization, participants were informed of their ideal viation of weight change of 2 kg, in accordance with a body weight, weight reduction target, and positive effect previous study [34]. The present study was designed to of weight reduction, as in the intervention group. have an 80 % power to detect a weight change of 2 kg in Table 1 Consultation content Intervention group Control group First consultation Explanations were given on the following: Explanations were given on the following: after randomization 2 2 Ideal body weight (body mass index, 22 kg/m ) and weight Ideal body weight (body mass index, 22 kg/m ) and weight reduction target of each participant (5 % body weight). reduction target of each participant (5 % body weight). The positive effect of weight reduction for the participant’s The positive effect of weight reduction for the participant’s present disease. present disease. A physician measured the participant’s body weight and provided specific advice on weight reduction at every routine consultation. Every subsequent Routine consultations were performed every 1 or 2 months Routine consultations were performed every 1 or 2 months routine consultation for the participant’s present disease based on the guidelines for the participant’s present disease based on the guidelines for the disease. for the disease. Body weight was measured. The physician questioned the patient on key lifestyle factors for weight reduction (i.e., eating, exercising, and weight monitoring) The physician provided information on the following standard lifestyle changes for obese people: Calorie intake (reduce calorie intake to 25 kcal/kg ideal body weight/day). Eat a well-balanced diet (calorie balance: protein, 10-15 %; fat, 20-25 %, and carbohydrate, 60 %). Exercise for 20-30 min at least three times per week. The physician provided advice focusing on weight reduction adjusted to each participant’s circumstances and lifestyle. Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 5 of 12 Table 2 Baseline demographic and clinical characteristics of participants n (%) or Median (interquartile range) Intervention Control p value n= 29 n= 21 Age (years) 56 (38 to 65) 55 (42 to 63) 0.94 Sex 0.39 Female 9 (31) 9 (43) Male 20 (69) 12 (57) Weight (kg) 71.8 (67.3 to 82.4) 74.1 (68.1 to 77.4) 0.84 Height (cm) 164.5 (156.5 to 168.3) 162.5 (154.5 to 168.1) 0.79 BMI (kg/m ) 27.6 (26.4 to 29.5) 27.6 (26.9 to 28.4) 0.78 Abdominal circumference (cm) 94.0 (91.8 to 98.0) 95.0 (92.0 to 97.5) 0.93 Blood pressure Systolic blood pressure (mmHg) 130 (120 to 140) 132 (120 to 138) 0.85 Diastolic blood pressure (mmHg) 82 (72 to 86) 78 (71 to 86) 0.88 Serum lipid profile Low-density lipoprotein (mg/dl) 128 (101 to 147) 126 (103 to 148) 0.86 High-density lipoprotein (mg/dl) 56 (45 to 61) 53 (45 to 62) 0.85 Triglyceride (mg/dl) 117 (88 to 171) 109 (88 to 126) 0.52 Fasting blood sugar (mg/dl) 100 (95 to 109) 102 (95 to 117) 0.42 Hemoglobin A1c (%) 5.5 (5.2 to 5.9) 5.7 (5.3 to 6.2) 0.15 Regular medication Antihypertensive drug 24 (82) 15 (71) 0.49 Lipid-lowering drug 9 (31) 7 (33) 0.86 Anti-diabetic drug 0 (0) 5 (24) 0.01 Medical history Hypertension 25 (86) 17 (81) 0.71 Dyslipidemia 11 (38) 8 (38) 0.99 Type 2 diabetes mellitus 2 (7) 6 (29) 0.06 Metabolic syndrome criteria Japanese criteria 15 (52) 6 (29) 0.10 NCEP-ATP III criteria 15 (52) 7 (33) 0.20 Educational background 0.48 Under high school 7 (24) 7 (33) High school and above 22 (76) 14 (67) Smoking 0.87 Non-smoker 24 (83) 17 (81) Currently smoker 5 (17) 4 (19) Alcohol drinking 0.53 Under once a week 14 (48) 12 (57) Once a week or more 15 (52) 9 (43) Weight self monitoring frequency 0.73 Under once a week 14 (48) 11 (52) Once a week or more 14 (48) 9 (43) Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 6 of 12 Table 2 Baseline demographic and clinical characteristics of participants (Continued) Home blood pressure monitoring 0.19 Regularly 24 (83) 14 (67) Not regularly 5 (17) 6 (33) We compared groups with the Mann–Whitney U test or Chi-squared test BMI, body mass index; NCEP-ATP, Cholesterol Education Program-Adult Treatment Panel Data were missing for one patient in the intervention group and one patient in the control group both groups. For this purpose, at least 17 participants 1-year follow up, we divided the participants into the were needed in each group. We considered p <0.05 as following two groups based on change in weight self- statistically significant. monitoring frequency: those with a decreased fre- quency (decreased group), and those with an increased Blinding or unchanged frequency (non-decreased group). We We informed the participants and the physicians, but then analyzed the relationship between amount of body not the nurses, of the randomization results at the first weight change at 1 year and the frequency, or change consultation after randomization. No measurement data in the frequency, of weight self-monitoring over the were given to the physicians. Analysis was performed year. Data were analyzed using the Kruskal-Wallis test after all data had been collected. and the Mann–Whitney U test. This study was approved by the Ethics Board of Statistical analyses Fukushima Medical University (No. 905) and is registered Analysis was based on the intention-to-treat principle. in the UMIN Clinical Trial Registry (UMIN 000002967). The categorical variables of baseline data were converted into binary categories, education background (<high school Results or ≥ high school), history of smoking (nonsmoker or For participants in both groups, the mean age (SD) was currently smoker), history of drinking alcohol (<once a 54.8 (6.7) years, mean body weight (SD) was 74.1 (9.6) kg, week or ≥onceaweek),and frequencyof bodyweight and mean BMI (SD) was 28.1 (2.1) kg/m . At baseline, no self-monitoring (<once a week or ≥onceaweek). We significant differences were evident between the groups analyzed baseline data between the two participant groups (Table 2). In one year follow-up period, 12 participants using the Mann–Whitney U test and Chi-squared test. changed regular prescription drugs (Table 3). The median The main outcome and secondary outcomes were ana- number of consultations (interquartile range [IQR]) was 8 lyzed using the Mann–Whitney U test. Statistical analysis (7 to 10) in the intervention group and 10 (9 to 11) in the was performed using SPSS Statistics (version 17.0; SPSS control group. The median consultation length (IQR) for Inc, Chicago, IL). each patient over the 1-year period was 59.1 (51.4 to 71.1) Ancillary analyses Table 3 Regular prescription drugs change between baseline Further analyses were conducted on the associations be- and the 1-year follow up tween body weight change and consultation factors. Data Number of participants, n (%) of 40 participants, regardless of their randomization group, Intervention group Control group who completed the 1-year follow up were used. We fo- n= 22 n= 18 cused on the consultation factors, which included the Antihypertensive drugs number of consultations over 1 year, total length of Increase 1 (5) 5 (28) consultations over the year, mean length of each consult- ation, and number of physicians who saw participants in Stable 21 (95) 13 (72) the clinic over the year, in order to calculate the total con- Decrease 0 0 sultation length over the year and the mean length of each Lipid-lowering drug consultation. The number of physicians who saw partici- Increase 3 (14) 1 (6) pants was obtained from the medical records. The associa- Stable 19 (86) 17 (94) tions of these factors with the change in body weight over Decrease 0 0 the 1-year period were analyzed using Spearman’srank correlation coefficient. Anti-diabetic In another ancillary analysis, we focused on the weight Increase 0 1 (6) self-monitoring factors, which included their frequency Stable 22 (100) 16 (88) and change over the 1-year period. From the self-reported Decrease 0 1 (6) weight self-monitoring frequency at baseline and at the Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 7 of 12 Table 4 Consultation factors in the intervention and control groups Median (interquartile range) Intervention group Control group p value n = 22 n = 18 Number of consultations in one year 8 (7 to 10) 10 (9 to 11) 0.01* Total consultation duration in one year (min) 59.1 (51.4 to 71.1) 79.7 (64.8 to 97.8) 0.002* Average duration of consultation (min) 7.0 (6.3 to 8.0) 8.0 (6.3 to 9.9) 0.13 We compared groups with the Mann–Whitney U test *Significantly different (p <0.05) between the groups min in the intervention group and 79.7 (64.8 to 97.8) min No significant differences in secondary outcomes were in the control group. The median length (IQR) of each noted between the groups; that is, the median (IQR) consultation was 7.0 (6.3 to 8) min in the intervention changes in the intervention and control groups at the group and 8.0 (6.4 to 9.8) min in the control group. The 1-year follow up were 0.0 (−3.5 to 1.5) cm and −1.2 median number of doctors (IQR) who saw each partici- (−2.8 to 1.0) cm for abdominal circumference, 2 (−12 to pant over the 1-year period was 2 (1 to 3) in the interven- 10) mmHg and −1(−10 to 7) mmHg for systolic blood tion group and 2 (1 to 3) in the control group. The pressure, and −2(−6 to 4) mmHg and −2(−10 to 8) number of consultations (p = 0.01) and the total consult- mmHg for diastolic blood pressure, respectively. The me- ation length (p = 0.002) were significantly different in both dian (IQR) changes in the intervention and control groups groups. The length of each consultation was not signifi- at 6 months were −1.0 (−2.3 to 0.6) kg and −1.9 (−3.8 to cantly different (p = 0.13) (Table 4). 0.6) kg for body weight, −1.1 (−2.4 to 0.9) cm and −2.8 Intention-to-treat analysis revealed that at 1 year, 15 (−4.0 to −0.4) cm for abdominal circumference, 0 (−6to9) participants in the intervention group (68 % of the group) mmHg and 0 (−15 to 7) mmHg for systolic blood pressure, and 9 participants in control group (50 % of the group) and −1(−6 to 7) mmHg and −2(−10 to 7) mmHg for had decreased their body weight from baseline values. diastolic blood pressure, respectively (Fig. 3). Again, no The median (IQR) change in body weight from baseline significant differences were observed between the groups. was −0.8 (−2.5 to 1.0) kg in the intervention group and 0.2 (−2.4 to 0.8) kg in the control group. There was no Ancillary analyses significant difference in this primary outcome (p = 0.68) In analysis of consultation factors, the mean number of observed between the groups (Fig. 2). consultations (SD) was 9.1 (2.1), mean total consultation Fig. 2 Box plots of body weight change at the 1-year follow up Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 8 of 12 In another ancillary analysis about body weight self- Body weight monitoring, at baseline, weight self-monitoring was per- formed less than once a month by 13 (33 %) participants, less than once a week by 8 (20 %) participants, several times per week by 11 (28 %) participants, and daily by 8 (20 %) participants. The median (IQR) of body weight change at the 1-year follow up was −0.6 (−2.7 to 0.7) kg in participants self-monitoring less than once a month, −0.4 (−2.2to0.9)kginthose self-monitoringlessthan oncea week, −1.7 (−2.9 to 1.1) kg in those self-monitoring several times per week, and −1.3 (−2.7to1.1)kginthose self- Abdominal circumference monitoring daily (Fig. 4). Analysis using the Kruskal-Wallis test showed no significant differences (p = 0.86). We calculated the change in the frequency of weight self- monitoring from baseline to the 1-year follow up (Table 5). Eight participants (21 %) had decreased their frequency of weight self-monitoring, 20 (54 %) showed no change, and 9 (24 %) had increased their frequency at the 1-year follow up. We analyzed body weight change over the 1-year period between the decreased group (n = 8) and the non- decreased group (n = 29). The median (IQR) changes in Systolic blood pressure body weight between baseline and the 1-year follow up were −1.8 (−2.7 to 0.6) kg in the non-decreased group and 0.9 (−0.4 to 1.8) kg in the decreased group, a significant difference (p = 0.009) between the groups (Fig. 5). It should be noted that the study area was affected by the Great East Japan Earthquake in March 2011, which occurred during the study period. In the aftermath, both water and gasoline were in short supply, which forced some participants to evacuate to community halls for Diastolic blood pressure several days. The 1-year follow up for 11 participants of the intervention group (50 % of the group) and 9 in the control group (50 % of the group) (total 20; 50 %) was done after the earthquake, and we analyzed the effect of the earthquake on body weight change using the Mann– Whitney U test (Table 6). No significant differences were observed in body weight change between the participants who attended the 1-year follow up before the earthquake and those who attended after it (p = 0.95). Fig. 3 Box plots of secondary outcomes Discussion length (SD) over 1 year was 70.6 (24.9) min, mean length We planned this study to reveal the effects on obese of each consultation (SD) was 7.8 (2.2) min, and mean Japanese patients of adding a brief intervention for body number of physicians who saw each participant (SD) weight reduction to routine consultations with a physician. was 2.1 (1.0). The correlation coefficient was 0.16 (p = We accomplish the randomized controlled trial at a family 0.31) for body weight change and the number of con- medicine clinic in the primary care setting. Given the lower sultations, 0.32 (p = 0.05) for body weight change and incidence rate of severe obesity in Japan than in developed the total consultation length, 0.30 (p = 0.06) for body Western countries [1, 4], we need an intervention method weight change and length of each consultation, and −0.01 that not only addresses severe obesity, but also overweight (p = 0.93) for body weight change and the number of phy- and moderate obesity. In this study, only 8 participants sicians who saw each participant. A weak positive correl- (16 %) were severely obese (BMI ≥30, Japanese criteria), ation was seen between body weight change and total and the average BMI was 28.1, which is classed as mod- consultation length over the year. erately obese. Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 9 of 12 Fig. 4 Box plots of body weight change at the 1-year follow up in relation to the frequency of self-monitoring at baseline Our results revealed no significant differences in con- have unintentionally overlooked other aspects of care sultation length between the intervention and control while being preoccupied with the measurement, keep- groups. This intervention method was performed briefly ing the consultation time shorter for the intervention as planned and proved suitable for short routine consul- group overall. tations. It is noteworthy that the present intervention Although we planned a brief and easy-to-perform inter- method is feasible for short routine consultations in the vention method for body weight reduction, no significant real-world clinical setting. additional effects on usual care were observed. On the The total consultation length was unexpectedly longer other hand, the result does not deny effect of all other in the control group than in the intervention group. The simple low cost interventions. Brief advice provided by consultation length for the control group might have physicians has been effective for quitting smoking [35] been longer because the control group had a higher ratio in the primary care setting, and simple intervention methods of participants who gained body weight. A possible ex- used by primary care physicians to encourage patients to planation for this finding is that physicians may have quit smoking have been established [36]. Weight reduction extended the duration of each consultation for patients is more complex than smoking cessation in two regards. who gained weight and may have kept consultations First, smoking is not essential to survival. Physicians, there- short for patients who maintained or lost weight. Alter- fore, can provide clear advice to stop smoking. On the other natively, physicians may have extended the consultation hand, patients cannot simply stop eating. Physicians can, time in general to measure body weight and provide ad- however, advise on how to eat. Quitting a behavior can vice to patients in the intervention group within the be a simpler approach than finding an appropriate way short consultation time allotted and in doing so might to adjust a behavior. Second, is the nature of underlying Table 5 Comparison of body weight self-monitoring frequency at baseline and at the 1-year follow up Number of participants, n (%) Frequency of body weight self-monitoring at the 1-year follow up <Once a month <Once a week >Once a week Daily Total Frequency at Baseline <Once a month 6 (16) 3 (8) 1 (3) 1 (3) 11 (29) <Once a week 3 (8) 3 (8) 2 (5) 0 (0) 8 (22) >Once a week 2 (5) 2 (5) 5 (14) 2 (5) 11 (29) Daily 0 (0) 1 (3) 0 (0) 6 (16) 7 (19) Total 11 (30) 9 (24) 8 (22) 9 (24) 37 (100) Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 10 of 12 Fig. 5 Box plots of body weight change in 1-year follow up by body weight self-monitoring frequency medical conditions. Since smoking is a behavioral risk care consultations, it may be useful to encompass multiple factor for health, physicians can focus their advice dir- brief and easy-to-perform approaches suited to short ectly on smoking behavior. On the other hand, obesity consultations. is a biomedical condition resulting from the interac- The approach of our clinic may affect outcomes. As tions between social, behavioral, cultural, physiological, effective doctor-patient communication can improve metabolic, and genetic factors [37]. To successfully re- patient health outcomes [24], family medicine trainees duce weight, obese patients need to change their eating, need to improve their skills in doctor-patient commu- exercising, working, and other behaviors. Consequently, nication during residency training. The family medicine physicians need to intervene in multiple factors for clinic, which served as a teaching clinic in the family weight reduction when dealing with obese patients. medicine residency program, had four family physicians. Multiple categories of intervention for body weight re- One of the physicians was a faculty member and the other duction are available. The intervention method used in three were senior trainees of family medicine. In this case, this study was based on a behavioral approach, for which more experienced family physicians could have made the we attached high value to an easy-to-perform method. difference in the intervention method. Previous studies have shown that intervention methods As another consideration for devising a brief and easy- involving multiple approaches for weight reduction to-perform intervention method, we noted weight self- are more effective than those with a single approach monitoring. In a previous study, Butryn and colleagues [14, 38, 39]. Thus, to develop an effective intervention showed that more frequent body weight self-monitoring method for reducing body weight during short, primary is related to body weight maintenance in patients who Table 6 Comparison of weight change at the 1-year follow up between before and after the Great East Japan Earthquake Total Before the earthquake After the earthquake Intervention group Number of participants 9 9 18 Weight change (kg) −0.4 kg −0.7 kg −0.5 kg Control group Number of participants 11 11 22 Weight change (kg) −1.0 kg −0.6 kg −0.8 kg Total Number of participants 20 20 40 Weight change (kg) −0.7 kg −0.6 kg −0.7 kg Mean weight change between baseline and the 1-year follow up Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 11 of 12 had lost weight [40]. Some researchers have proposed Competing interests Part of this study was financially supported by the Jinsenkai Public Interest that weight self-monitoring increases obese patients’ Incorporated Foundation. awareness of their weight and results in them modifying their eating and exercise behavior [41]. The result of Authors’ contributions ancillary analysis revealed the relationship between SK designed this study, analyzed data, and drafted the manuscript. TK participated in the analyses and drafted the manuscript. NT and YM carried self-monitoring frequency at baseline and body weight out participants’ intervention. AI carried out randomization of participants. RK reduction, as well as that between change in body weight supervised all the study process and reviewed the manuscript. All authors self-monitoring frequency and body weight reduction. read and approved the final manuscript. We,therefore,considerit worthwhile to explorethis relationship further in a future prospective study. Acknowledgement We thank Kimie Iizuka, Tomoko Yoshida, and Emiko Furukawa for their This study has several limitations. First, it was con- assistance in measuring patient parameters. We are also grateful to all the ducted at a single family medicine clinic, where it was participants in this study. difficult to analyze subjects by sex, age, and other factors Author details due to the number of eligible patients. If the number of Department of Community and Family Medicine, Fukushima Medical participants had been larger, we might detect modest University, 1 Hikarigaoka, Fukushima City, Fukushima Prefecture, Japan. weight reduction. And if the observation period had Department of Internal Medicine, Kashima Hospital, 22-1 Shimokuramochi Nakasawame, Kashima-machi, Iwaki City, Fukushima Prefecture, Japan. been longer, we might detect long-term weight change. In real primary care setting, even if effect sizes are small, Received: 10 October 2014 Accepted: 12 May 2015 simple low-cost intervention methods can be used with- out too much difficulty for years and, therefore, they are of benefit to the patients. A cluster randomized con- References 1. Ministry of Health, Labour and Welfare, Japan: 2011 Patient survey. trolled multicenter design is a possible solution for as- http://www.mhlw.go.jp/english/database/db-hss/sps_2011.html. sembling more participants and acquiring more evidence Accessed 13 Nov 2013 with greater power. The second limitation is that this 2. Mokdad AH, Ford ES, Bowman BA, Dietz WH, Vinicor F, Bales VS, et al. Prevalence of obesity, diabetes, and obesity-related health risk factors, study was conducted in the Japanese clinical setting, 2001. JAMA. 2003;289:76–9. which differs from that in Western countries in terms of 3. Xiao J, Yang W. Weight loss is still an essential intervention in obesity and shorter and more frequent consultations. The third limi- its complications: a review. J Obes. 2012;2012:1–6. 4. World Health Organization. Obesity and overweight WHO fact sheet No311. tation is that the intervention method was affected by doctor-patient communication as we did not strictly 5. Ministry of Health, Labour and Welfare, Japan: 2011 National Health and standardize the weight reduction advice provided by the Nutrition Survey. http://www.mhlw.go.jp/bunya/kenkou/kenkou_eiyou_ chousa.html. Accessed 11 Nov 2013. [in Japanese] physicians. This might have resulted in inter-physician 6. Kanazawa M, Yoshiike N, Osaka T, Numba Y, Zimmet P, Inoue S. Criteria and differences in the intervention, which were not measured. classification of obesity in Japan and Asia-Oceania. Asia Pac J Clin Nutr. If we had evaluated doctor-patient communication, we 2002;11 Suppl 8:S732–7. 7. World Health Organization. Appropriate body-mass index for Asian would have been able to take variables of patients’ view- populations and its implications for policy and intervention strategies. point. The fourth limitation is that this study did not have Lancet. 2004;363:157–63. data about diet and exercise. We could not analyze 8. Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, et al. 2013 AHA/ACC/TOS Guideline for the Management of about food choice and other actions of the participants. Overweight and Obesity in Adults: A Report of the American A final limitation is the effects of the Great East Japan College of Cardiology/American Heart Association Task Force on Earthquake. In particular, we could not eliminate the effects Practice Guidelines and The Obesity Society. Circulation. 2014;129(25 Suppl 2):S102–38. doi:10.1161/01.cir.0000437739.71477.ee. Epub 2013 of the earthquake because of thesmall studypopulation. Nov 12.S102-38. 9. Galuska DA, Will JC, Serdula MK, Ford ES. 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Nanchahal K, Townsend J, Letley L, Haslam D, Wellings K, Haines A. studies on simple and easy-to-perform intervention methods Weight-management interventions in primary care: a pilot randomised are needed. Taken together, the present findings revealed a controlled trial. Br J Gen Pract. 2009;59:157–66. 15. ter Bogt NCW, Bemelmans WJE, Beltman FW, Broer J, Smit AJ, van der Meer K. potential research question on the relationship between Preventing weight gain by lifestyle intervention in a general practice setting: weight self-monitoring and body weight reduction in three-year results of a randomized controlled trial. Arch Intern Med. the primary care setting. 2011;171:306–13. Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 12 of 12 16. Bennett GG, Herring SJ, Puleo E, Stein EK, Emmons KM, Gillman MW. 39. Wu T, Gao X, Chen M, van Dam RM. 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Vanina Y, Podolskaya A, Sedky K, Shahab H, Siddiqui A, Munshi F, et al. Body weight changes associated with psychopharmacology. Psychiatr Serv. 2002;53:842–7. 27. Espeland MA, Stefanick ML, Kritz-Silverstein D, Fineberg SE, Waclawiw MA, James MK, et al. Effect of postmenopausal hormone therapy on body weight and waist and hip girths. Postmenopausal Estrogen- Progestin Interventions Study Investigators. J Clin Endocrinol Metab. 1997;82:1549–56. 28. Committee to Evaluate Diagnostic Standards for Metabolic Syndrome. Definition and the diagnostic standard for metabolic syndrome–Committee to Evaluate Diagnostic Standards for Metabolic Syndrome. Nippon Naika Gakkai Zasshi. 2005;94:794–809. in Japanese. 29. Grundy SM. Diagnosis and management of the metabolic syndrome: an American heart association/national heart, lung, and blood institute scientific statement. Circulation. 2005;112:2735–52. 30. Japan Society for the Study of Obesity. Obesity disease treatment guideline 2006. 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Submit your next manuscript to BioMed Central 2013;5:CD000165. and take full advantage of: 36. US Department of Health and Human Services Tobacco Use and Dependence Guideline Panel: Treating Tobacco Use and Dependence: • Convenient online submission 2008 update. http://www.ahrq.gov/professionals/clinicians-providers/ • Thorough peer review guidelinesrecommendations/tobacco/clinicians/update/ treating_tobacco_use08.pdf. Accessed 5 Jan 2014 • No space constraints or color figure charges 37. NHLBI Obesity Education Initiative Expert Panel on the Identification, • Immediate publication on acceptance Evaluation, and Treatment of Obesity in Adults: Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in • Inclusion in PubMed, CAS, Scopus and Google Scholar Adults. Bethesda; 1998 • Research which is freely available for redistribution 38. Jakicic JM, Tate DF, Lang W, Davis KK, Polzien K, Rickman AD, et al. Effect of a stepped-care intervention approach on weight loss in adults: a randomized Submit your manuscript at clinical trial. JAMA. 2012;307:2617–26. www.biomedcentral.com/submit http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Asia Pacific Family Medicine Springer Journals

Interventions for body weight reduction in obese patients during short consultations: an open-label randomized controlled trial in the Japanese primary care setting

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Copyright © 2015 by Kanke et al.; licensee BioMed Central.
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Medicine & Public Health; General Practice / Family Medicine; Primary Care Medicine
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10.1186/s12930-015-0022-7
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26015773
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Abstract

Background: Family physicians should maintain regular contact with obese patients to ensure they effectively reduce their body weight. However, family physicians in Japan have on average only 6 (min) per consultation, and conventional interventions for body weight reduction require a longer consultation or additional manpower. A brief intervention within the limited consultation time available is therefore needed. Here we investigated the effectiveness of a brief weight reduction intervention for obese patients and the related factors for reducing body weight during routine consultations in the primary care setting. Method: We conducted an open-label randomized controlled trial at a family medicine clinic in Fukushima, Japan from January 2010 to June 2011. Patients aged 30 to 69 years with body mass index ≥25 who were diagnosed with hypertension, dyslipidemia, and/or type 2 diabetes mellitus were randomly assigned to the intervention or control group. At every consultation, body weight in the intervention group was measured by a family physician who provided weight reduction advice in addition to usual care. The primary outcome was body weight change at 1-year follow up. Analysis was done by intention to treat. Result: We randomly assigned 29 participants to the intervention group and 21 to the control group. Forty participants (80 %) remained in the trial until the 1-year follow up. At follow up, the median body weight change from baseline was not significantly different between the groups (p = 0.68), at −0.8 (interquartile range [IQR] −2.5 to 1.0) kg in the intervention group and 0.2 (IQR −2.4 to 0.8) kg in the control group. Conclusion: We devised an intervention method for physicians to measure body weight and advise on weight reduction during routine consultations. In our setting, this method did not extend the consultation time, but also had no significant additional effects on body weight reduction in moderately obese patients. Trial registration: This trial is registered with the UMIN Clinical Trial Registry (UMIN000002967). Keywords: Obesity, Weight reduction, Brief intervention, Primary care, Outpatient care, Short consultation Background million, and those with type 2 diabetes from 2.3 million The number of patients with hypertension, dyslipidemia, to 2.7 million [1]. All three of these diseases are related or type 2 diabetes mellitus has increased in the last few to obesity [2, 3]. In 2008, more than 10 % of the world’s decades in Japan [1]. From 2002 to 2011, the number of adult population was obese according to the World patients with hypertension increased from 7 million to 9 Health Organization’s definition of a body mass index million, those with dyslipidemia from 1.4 million to 1.9 (BMI) ≥30 kg/m [4], although only 3 % of the Japanese population in 2011 conformed to this definition of obes- ity [5]. As the incidence rates of obesity-related diseases * Correspondence: kanke@fmu.ac.jp Department of Community and Family Medicine, Fukushima Medical in Japan have been increasing, an international expert University, 1 Hikarigaoka, Fukushima City, Fukushima Prefecture, Japan panel proposed a lower BMI cut-off for the Japanese Full list of author information is available at the end of the article © 2015 Kanke et al.; licensee BioMed Central. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 2 of 12 population [6]. The current definition of obesity for reduction strategies consist of the following five approaches: Japanese is BMI ≥25 kg/m [7]. According to this definition, dietary intervention, physical activity, behavioral treatment, 30 % of Japanese adult men and 21 % of Japanese adult pharmacotherapy, and surgical therapy [3]. Many stud- women were reported to be obese in 2011 [5]. Developing ies in the primary care setting have reported the effects an effective intervention for reducing the body weight of of dietary intervention, physical activity, and pharmaco- obese Japanese patients has the potential to improve the therapy on body weight reduction in obese patients management of obesity-related diseases. [13–15]. However, weight monitoring is a component Although the guidelines for managing overweight and of behavioral treatment, and in the area of behavioral obesity recommend advising patients with obesity-related treatment, most studies on body weight reduction have diseases to lose weight [8], the weight reduction approach applied an intensive approach in an academic setting; of healthcare providers remains inadequate [9]. Primary few studies have reported the effects of behavioral treatment care physicians meet many obese patients with obesity- on body weight reduction in the primary care setting [22]. related diseases [10] and should maintain regular contact Against this background, we hypothesized that if phy- with thesepatientstoensuretheyreducetheir body sicians involved in outpatient care measure patient body weight as necessary. Epstein and Ogden revealed conflict- weight and advise on weight reduction at every consult- ing points of view between primary care physicians and ation, this approach might reduce the body weight of obese obese patients. Obese patients regarded obesity as a med- patients since it can be performed quickly and easily. There ical problem that should be managed by the physicians. In are several important points regarding the approach taken contrast, physicians consider obesity management to be in this study. First, obese patients should monitor their primarily the patient’s responsibility. One of the reasons weight with their physician since weight monitoring en- for this discord is the lack of effective patient interventions ables obese patients to recognize their actual condition. in the primary care setting [11]. In the primary care set- We planned weight monitoring with a physician at every ting, physicians need a brief and easy-to-perform inter- consultation to ensure a sense of urgency and motivation vention method for encouraging obese patients to lose for lifestyle change. Second, physicians should ask patients weight. Because physicians manage on average three about their lifestyles based on the measured body weight problems during each short consultation [12], it is too and provide specific advice on aspects that are difficult to difficult to provide the proven intervention methods improve. Third, an intervention method for lifestyle change established in other studies in a real-world clinical set- is needed to improve doctor-patient relationships [23, 24]. ting. In previous studies conducted in the primary care Fourth, we planned to establish a trust relationship by setting outside of Japan, patient body weight has been requesting the physician to advise on the intervention effectively reduced through lifestyle counseling provided method. The objective of this study, therefore, was to by medical assistants, nurses, or dietitians [13–15], as well devise a brief and easy-to-perform intervention method as by Internet-based intervention programs [16, 17]. In for body weight reduction in the Japanese primary care Japan, providing these interventions in the primary care setting. setting is difficult because very few dietitians work for pri- mary care clinics and clinic nurses do not have sufficient Methods experience in lifestyle counseling. In fact, most lifestyle Design and participants counseling is given by Japanese primary care physicians We planned an open-label randomized control study at during regular patient visits [18]. In other studies, physi- a family medicine clinic (Date City, Fukushima Prefecture, cians have provided tailored intervention to obese patients Japan) attended by four family physicians. Date city is lo- during 15 to 20-min long consultations [19, 20]; however, cated 250 km north of Tokyo, its population was about in Japan, primary care consultations last for around 6 min 66,000 people in 2010, and main industry of the city is [21], meaning that primary care physicians cannot practic- agriculture. From January to June 2010, we checked the ally provide any effective counseling-based interventions medical records of adult patients aged 30–69 years who due to time constraints. In the Japanese primary care set- visited the family medicine department for routine checkups ting, physicians need simple and easy-to-perform methods for hypertension, dyslipidemia, and/or type 2 diabetes of intervention that are suitable for use in routine brief mellitus. A total of 180 patients were matched in January consultations. 2010. From the pool, we recruited 57 patients with a In our clinical experience, some of our obese patients, BMI ≥25 kg/m (moderately to severely obese) to par- whose body weight was checked by the physician at every ticipate in this study. We excluded patients with a history consultation, managed to reduce their body weight. Based of cancer or psychological disease, or those prescribed hor- on this success, we focused on body weight monitoring mone therapy because these factors are known to affect as an innovative method for promoting body weight re- body weight [25–27]. We informed all participants of the duction in the primary care setting. In general, weight aim and content of the study, and obtained their written Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 3 of 12 consent to participate. After being informed of this research abdominal circumference, and blood pressure. After defe- project, 51 patients agreed to participate. One participant cating and urinating, participants removed their shoes and with a history of cancer was excluded. At baseline measure- wore as light clothing as possible for height and body ment, 50 participants (18 women, 36 %; 32 men, 64 %) were weight measurement on a digital scale. Abdominal circum- enrolled. We randomized 29 participants to the interven- ference was measured at the umbilical level with a tape tion group and 21 participants to the control group. In measure in the standing position and at end-expiratory total, 44 participants (88 %) were assessed for body weight pressure [28], and blood pressure was measured in the sit- changes at 6 months, and 40 participants (80 %) remained ting position with an automated sphygmomanometer after in the study until the 1-year follow up (Fig. 1). a few minutes rest. We checked these data and the partici- pants’ medical records to ensure the participants met the Baseline data and measurement criteria for metabolic syndrome (Japanese criteria and the After the participants agreed to participate, their physician National Cholesterol Education Program-Adult Treatment collected the following baseline data: age, sex, history of Panel III criteria) [28, 29]. hypertension (yes or no), history of dyslipidemia (yes or no), history of type 2 diabetes (yes or no), educational background (junior high school, high school, technical Randomization college, or university), history of smoking (never smoker, Participants were assigned original identification numbers, former smoker, or current smoker), history of alcohol which were sent to a co-researcher (AI) working at an- consumption (never drinker, <once a week, <3 times per other hospital who randomized these numbers into two week, <6 times per week, or daily), and frequency of body groups (intervention group and control group) by means weight self-monitoring (<once a month, <once a week, of a table of random numbers. The randomization results several times per week, or daily). were sent to the chief researcher (SK) who informed the Nurses, who were blinded to the group assignment of participants. Figure 1 shows the participant flow through- each patient, measured participant height, body weight, out the study. Patients aged 30-69 years old diagnosed as having hypertension, dyslipidemia, or type 2 diabetes mellitus (n=180) BMI <25 (n=123) (n=57) Excluded (n=4) Did not agree to participate (n=2) Screening and baseline measurement (n=51) Excluded (n=1) Enrolled and randomized (n=50) Intervention group Control group (n=29) (n=21) Loss of contact Loss of contact (n=3) (n=2) Excluded (n=1) Follow up at 6 Follow up at 6 months months (n=25) (n=19) Moving house (n=1) Loss of contact Loss of contact (n=1) (n=2) Follow up at 1 year Follow up at 1 year (n=22) (n=18) Fig. 1 Participant flow chart Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 4 of 12 Intervention Thereafter, participants received care for their current In the intervention group, at the first consultation after diseases based on the Japanese guidelines every 1 or 2 randomization, participants were informed about their months. However, the physician was not required to meas- ideal body weight, weight reduction target (5 % of current ure body weight or discuss body weight reduction at every weight), and the positive effect of weight reduction for consultation. their current diseases by the physician, who provided them with an information leaflet [30]. Participants were Outcomes also informed that a physician would check their body The primary outcome of this study was change in body weight and provide specific advice on weight reduction weight at 1-year follow up. Secondary outcomes were at every regular consultation. Thereafter, the participants changes in body weight at 6-month follow up, and changes received care for their current diseases based on the in abdominal circumference and blood pressure at the 6- Japanese guidelines for hypertension, dyslipidemia, and month and 1-year follow ups. Nurses blinded to the group type 2 diabetes [31–33] every 1 or 2 months. A physician assignment of each patient measured body weight, abdom- measured body weight after defecation and micturition inal circumference, and blood pressure at 6 months and 1 using an analogue scale at every consultation and provided year. The nurses then asked the participants about their advice in relation to the changes of measured body weight frequency of weight self-monitoring at the 1-year follow up at each consultation. In addition, at every consultation, using the same classification as that used at baseline. Physi- the physician was required to specifically question the pa- cians recorded the length (in minutes and seconds) of each tient on eating and exercise, to reconfirm the patient’s consultation and calculated the mean length for each weight target, and to provide advice focusing on each patient after all participants had completed the 1-year participant’s difficulties in lifestyle change. We requested follow up. all physicians to perform this intervention, even if the con- sultation duration exceeded the usual appointment time Sample size calculation (Table 1). We selected a mean weight difference of 2 kg after 1 In the control group, at the first consultation after year as clinically significant and assumed a standard de- randomization, participants were informed of their ideal viation of weight change of 2 kg, in accordance with a body weight, weight reduction target, and positive effect previous study [34]. The present study was designed to of weight reduction, as in the intervention group. have an 80 % power to detect a weight change of 2 kg in Table 1 Consultation content Intervention group Control group First consultation Explanations were given on the following: Explanations were given on the following: after randomization 2 2 Ideal body weight (body mass index, 22 kg/m ) and weight Ideal body weight (body mass index, 22 kg/m ) and weight reduction target of each participant (5 % body weight). reduction target of each participant (5 % body weight). The positive effect of weight reduction for the participant’s The positive effect of weight reduction for the participant’s present disease. present disease. A physician measured the participant’s body weight and provided specific advice on weight reduction at every routine consultation. Every subsequent Routine consultations were performed every 1 or 2 months Routine consultations were performed every 1 or 2 months routine consultation for the participant’s present disease based on the guidelines for the participant’s present disease based on the guidelines for the disease. for the disease. Body weight was measured. The physician questioned the patient on key lifestyle factors for weight reduction (i.e., eating, exercising, and weight monitoring) The physician provided information on the following standard lifestyle changes for obese people: Calorie intake (reduce calorie intake to 25 kcal/kg ideal body weight/day). Eat a well-balanced diet (calorie balance: protein, 10-15 %; fat, 20-25 %, and carbohydrate, 60 %). Exercise for 20-30 min at least three times per week. The physician provided advice focusing on weight reduction adjusted to each participant’s circumstances and lifestyle. Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 5 of 12 Table 2 Baseline demographic and clinical characteristics of participants n (%) or Median (interquartile range) Intervention Control p value n= 29 n= 21 Age (years) 56 (38 to 65) 55 (42 to 63) 0.94 Sex 0.39 Female 9 (31) 9 (43) Male 20 (69) 12 (57) Weight (kg) 71.8 (67.3 to 82.4) 74.1 (68.1 to 77.4) 0.84 Height (cm) 164.5 (156.5 to 168.3) 162.5 (154.5 to 168.1) 0.79 BMI (kg/m ) 27.6 (26.4 to 29.5) 27.6 (26.9 to 28.4) 0.78 Abdominal circumference (cm) 94.0 (91.8 to 98.0) 95.0 (92.0 to 97.5) 0.93 Blood pressure Systolic blood pressure (mmHg) 130 (120 to 140) 132 (120 to 138) 0.85 Diastolic blood pressure (mmHg) 82 (72 to 86) 78 (71 to 86) 0.88 Serum lipid profile Low-density lipoprotein (mg/dl) 128 (101 to 147) 126 (103 to 148) 0.86 High-density lipoprotein (mg/dl) 56 (45 to 61) 53 (45 to 62) 0.85 Triglyceride (mg/dl) 117 (88 to 171) 109 (88 to 126) 0.52 Fasting blood sugar (mg/dl) 100 (95 to 109) 102 (95 to 117) 0.42 Hemoglobin A1c (%) 5.5 (5.2 to 5.9) 5.7 (5.3 to 6.2) 0.15 Regular medication Antihypertensive drug 24 (82) 15 (71) 0.49 Lipid-lowering drug 9 (31) 7 (33) 0.86 Anti-diabetic drug 0 (0) 5 (24) 0.01 Medical history Hypertension 25 (86) 17 (81) 0.71 Dyslipidemia 11 (38) 8 (38) 0.99 Type 2 diabetes mellitus 2 (7) 6 (29) 0.06 Metabolic syndrome criteria Japanese criteria 15 (52) 6 (29) 0.10 NCEP-ATP III criteria 15 (52) 7 (33) 0.20 Educational background 0.48 Under high school 7 (24) 7 (33) High school and above 22 (76) 14 (67) Smoking 0.87 Non-smoker 24 (83) 17 (81) Currently smoker 5 (17) 4 (19) Alcohol drinking 0.53 Under once a week 14 (48) 12 (57) Once a week or more 15 (52) 9 (43) Weight self monitoring frequency 0.73 Under once a week 14 (48) 11 (52) Once a week or more 14 (48) 9 (43) Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 6 of 12 Table 2 Baseline demographic and clinical characteristics of participants (Continued) Home blood pressure monitoring 0.19 Regularly 24 (83) 14 (67) Not regularly 5 (17) 6 (33) We compared groups with the Mann–Whitney U test or Chi-squared test BMI, body mass index; NCEP-ATP, Cholesterol Education Program-Adult Treatment Panel Data were missing for one patient in the intervention group and one patient in the control group both groups. For this purpose, at least 17 participants 1-year follow up, we divided the participants into the were needed in each group. We considered p <0.05 as following two groups based on change in weight self- statistically significant. monitoring frequency: those with a decreased fre- quency (decreased group), and those with an increased Blinding or unchanged frequency (non-decreased group). We We informed the participants and the physicians, but then analyzed the relationship between amount of body not the nurses, of the randomization results at the first weight change at 1 year and the frequency, or change consultation after randomization. No measurement data in the frequency, of weight self-monitoring over the were given to the physicians. Analysis was performed year. Data were analyzed using the Kruskal-Wallis test after all data had been collected. and the Mann–Whitney U test. This study was approved by the Ethics Board of Statistical analyses Fukushima Medical University (No. 905) and is registered Analysis was based on the intention-to-treat principle. in the UMIN Clinical Trial Registry (UMIN 000002967). The categorical variables of baseline data were converted into binary categories, education background (<high school Results or ≥ high school), history of smoking (nonsmoker or For participants in both groups, the mean age (SD) was currently smoker), history of drinking alcohol (<once a 54.8 (6.7) years, mean body weight (SD) was 74.1 (9.6) kg, week or ≥onceaweek),and frequencyof bodyweight and mean BMI (SD) was 28.1 (2.1) kg/m . At baseline, no self-monitoring (<once a week or ≥onceaweek). We significant differences were evident between the groups analyzed baseline data between the two participant groups (Table 2). In one year follow-up period, 12 participants using the Mann–Whitney U test and Chi-squared test. changed regular prescription drugs (Table 3). The median The main outcome and secondary outcomes were ana- number of consultations (interquartile range [IQR]) was 8 lyzed using the Mann–Whitney U test. Statistical analysis (7 to 10) in the intervention group and 10 (9 to 11) in the was performed using SPSS Statistics (version 17.0; SPSS control group. The median consultation length (IQR) for Inc, Chicago, IL). each patient over the 1-year period was 59.1 (51.4 to 71.1) Ancillary analyses Table 3 Regular prescription drugs change between baseline Further analyses were conducted on the associations be- and the 1-year follow up tween body weight change and consultation factors. Data Number of participants, n (%) of 40 participants, regardless of their randomization group, Intervention group Control group who completed the 1-year follow up were used. We fo- n= 22 n= 18 cused on the consultation factors, which included the Antihypertensive drugs number of consultations over 1 year, total length of Increase 1 (5) 5 (28) consultations over the year, mean length of each consult- ation, and number of physicians who saw participants in Stable 21 (95) 13 (72) the clinic over the year, in order to calculate the total con- Decrease 0 0 sultation length over the year and the mean length of each Lipid-lowering drug consultation. The number of physicians who saw partici- Increase 3 (14) 1 (6) pants was obtained from the medical records. The associa- Stable 19 (86) 17 (94) tions of these factors with the change in body weight over Decrease 0 0 the 1-year period were analyzed using Spearman’srank correlation coefficient. Anti-diabetic In another ancillary analysis, we focused on the weight Increase 0 1 (6) self-monitoring factors, which included their frequency Stable 22 (100) 16 (88) and change over the 1-year period. From the self-reported Decrease 0 1 (6) weight self-monitoring frequency at baseline and at the Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 7 of 12 Table 4 Consultation factors in the intervention and control groups Median (interquartile range) Intervention group Control group p value n = 22 n = 18 Number of consultations in one year 8 (7 to 10) 10 (9 to 11) 0.01* Total consultation duration in one year (min) 59.1 (51.4 to 71.1) 79.7 (64.8 to 97.8) 0.002* Average duration of consultation (min) 7.0 (6.3 to 8.0) 8.0 (6.3 to 9.9) 0.13 We compared groups with the Mann–Whitney U test *Significantly different (p <0.05) between the groups min in the intervention group and 79.7 (64.8 to 97.8) min No significant differences in secondary outcomes were in the control group. The median length (IQR) of each noted between the groups; that is, the median (IQR) consultation was 7.0 (6.3 to 8) min in the intervention changes in the intervention and control groups at the group and 8.0 (6.4 to 9.8) min in the control group. The 1-year follow up were 0.0 (−3.5 to 1.5) cm and −1.2 median number of doctors (IQR) who saw each partici- (−2.8 to 1.0) cm for abdominal circumference, 2 (−12 to pant over the 1-year period was 2 (1 to 3) in the interven- 10) mmHg and −1(−10 to 7) mmHg for systolic blood tion group and 2 (1 to 3) in the control group. The pressure, and −2(−6 to 4) mmHg and −2(−10 to 8) number of consultations (p = 0.01) and the total consult- mmHg for diastolic blood pressure, respectively. The me- ation length (p = 0.002) were significantly different in both dian (IQR) changes in the intervention and control groups groups. The length of each consultation was not signifi- at 6 months were −1.0 (−2.3 to 0.6) kg and −1.9 (−3.8 to cantly different (p = 0.13) (Table 4). 0.6) kg for body weight, −1.1 (−2.4 to 0.9) cm and −2.8 Intention-to-treat analysis revealed that at 1 year, 15 (−4.0 to −0.4) cm for abdominal circumference, 0 (−6to9) participants in the intervention group (68 % of the group) mmHg and 0 (−15 to 7) mmHg for systolic blood pressure, and 9 participants in control group (50 % of the group) and −1(−6 to 7) mmHg and −2(−10 to 7) mmHg for had decreased their body weight from baseline values. diastolic blood pressure, respectively (Fig. 3). Again, no The median (IQR) change in body weight from baseline significant differences were observed between the groups. was −0.8 (−2.5 to 1.0) kg in the intervention group and 0.2 (−2.4 to 0.8) kg in the control group. There was no Ancillary analyses significant difference in this primary outcome (p = 0.68) In analysis of consultation factors, the mean number of observed between the groups (Fig. 2). consultations (SD) was 9.1 (2.1), mean total consultation Fig. 2 Box plots of body weight change at the 1-year follow up Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 8 of 12 In another ancillary analysis about body weight self- Body weight monitoring, at baseline, weight self-monitoring was per- formed less than once a month by 13 (33 %) participants, less than once a week by 8 (20 %) participants, several times per week by 11 (28 %) participants, and daily by 8 (20 %) participants. The median (IQR) of body weight change at the 1-year follow up was −0.6 (−2.7 to 0.7) kg in participants self-monitoring less than once a month, −0.4 (−2.2to0.9)kginthose self-monitoringlessthan oncea week, −1.7 (−2.9 to 1.1) kg in those self-monitoring several times per week, and −1.3 (−2.7to1.1)kginthose self- Abdominal circumference monitoring daily (Fig. 4). Analysis using the Kruskal-Wallis test showed no significant differences (p = 0.86). We calculated the change in the frequency of weight self- monitoring from baseline to the 1-year follow up (Table 5). Eight participants (21 %) had decreased their frequency of weight self-monitoring, 20 (54 %) showed no change, and 9 (24 %) had increased their frequency at the 1-year follow up. We analyzed body weight change over the 1-year period between the decreased group (n = 8) and the non- decreased group (n = 29). The median (IQR) changes in Systolic blood pressure body weight between baseline and the 1-year follow up were −1.8 (−2.7 to 0.6) kg in the non-decreased group and 0.9 (−0.4 to 1.8) kg in the decreased group, a significant difference (p = 0.009) between the groups (Fig. 5). It should be noted that the study area was affected by the Great East Japan Earthquake in March 2011, which occurred during the study period. In the aftermath, both water and gasoline were in short supply, which forced some participants to evacuate to community halls for Diastolic blood pressure several days. The 1-year follow up for 11 participants of the intervention group (50 % of the group) and 9 in the control group (50 % of the group) (total 20; 50 %) was done after the earthquake, and we analyzed the effect of the earthquake on body weight change using the Mann– Whitney U test (Table 6). No significant differences were observed in body weight change between the participants who attended the 1-year follow up before the earthquake and those who attended after it (p = 0.95). Fig. 3 Box plots of secondary outcomes Discussion length (SD) over 1 year was 70.6 (24.9) min, mean length We planned this study to reveal the effects on obese of each consultation (SD) was 7.8 (2.2) min, and mean Japanese patients of adding a brief intervention for body number of physicians who saw each participant (SD) weight reduction to routine consultations with a physician. was 2.1 (1.0). The correlation coefficient was 0.16 (p = We accomplish the randomized controlled trial at a family 0.31) for body weight change and the number of con- medicine clinic in the primary care setting. Given the lower sultations, 0.32 (p = 0.05) for body weight change and incidence rate of severe obesity in Japan than in developed the total consultation length, 0.30 (p = 0.06) for body Western countries [1, 4], we need an intervention method weight change and length of each consultation, and −0.01 that not only addresses severe obesity, but also overweight (p = 0.93) for body weight change and the number of phy- and moderate obesity. In this study, only 8 participants sicians who saw each participant. A weak positive correl- (16 %) were severely obese (BMI ≥30, Japanese criteria), ation was seen between body weight change and total and the average BMI was 28.1, which is classed as mod- consultation length over the year. erately obese. Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 9 of 12 Fig. 4 Box plots of body weight change at the 1-year follow up in relation to the frequency of self-monitoring at baseline Our results revealed no significant differences in con- have unintentionally overlooked other aspects of care sultation length between the intervention and control while being preoccupied with the measurement, keep- groups. This intervention method was performed briefly ing the consultation time shorter for the intervention as planned and proved suitable for short routine consul- group overall. tations. It is noteworthy that the present intervention Although we planned a brief and easy-to-perform inter- method is feasible for short routine consultations in the vention method for body weight reduction, no significant real-world clinical setting. additional effects on usual care were observed. On the The total consultation length was unexpectedly longer other hand, the result does not deny effect of all other in the control group than in the intervention group. The simple low cost interventions. Brief advice provided by consultation length for the control group might have physicians has been effective for quitting smoking [35] been longer because the control group had a higher ratio in the primary care setting, and simple intervention methods of participants who gained body weight. A possible ex- used by primary care physicians to encourage patients to planation for this finding is that physicians may have quit smoking have been established [36]. Weight reduction extended the duration of each consultation for patients is more complex than smoking cessation in two regards. who gained weight and may have kept consultations First, smoking is not essential to survival. Physicians, there- short for patients who maintained or lost weight. Alter- fore, can provide clear advice to stop smoking. On the other natively, physicians may have extended the consultation hand, patients cannot simply stop eating. Physicians can, time in general to measure body weight and provide ad- however, advise on how to eat. Quitting a behavior can vice to patients in the intervention group within the be a simpler approach than finding an appropriate way short consultation time allotted and in doing so might to adjust a behavior. Second, is the nature of underlying Table 5 Comparison of body weight self-monitoring frequency at baseline and at the 1-year follow up Number of participants, n (%) Frequency of body weight self-monitoring at the 1-year follow up <Once a month <Once a week >Once a week Daily Total Frequency at Baseline <Once a month 6 (16) 3 (8) 1 (3) 1 (3) 11 (29) <Once a week 3 (8) 3 (8) 2 (5) 0 (0) 8 (22) >Once a week 2 (5) 2 (5) 5 (14) 2 (5) 11 (29) Daily 0 (0) 1 (3) 0 (0) 6 (16) 7 (19) Total 11 (30) 9 (24) 8 (22) 9 (24) 37 (100) Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 10 of 12 Fig. 5 Box plots of body weight change in 1-year follow up by body weight self-monitoring frequency medical conditions. Since smoking is a behavioral risk care consultations, it may be useful to encompass multiple factor for health, physicians can focus their advice dir- brief and easy-to-perform approaches suited to short ectly on smoking behavior. On the other hand, obesity consultations. is a biomedical condition resulting from the interac- The approach of our clinic may affect outcomes. As tions between social, behavioral, cultural, physiological, effective doctor-patient communication can improve metabolic, and genetic factors [37]. To successfully re- patient health outcomes [24], family medicine trainees duce weight, obese patients need to change their eating, need to improve their skills in doctor-patient commu- exercising, working, and other behaviors. Consequently, nication during residency training. The family medicine physicians need to intervene in multiple factors for clinic, which served as a teaching clinic in the family weight reduction when dealing with obese patients. medicine residency program, had four family physicians. Multiple categories of intervention for body weight re- One of the physicians was a faculty member and the other duction are available. The intervention method used in three were senior trainees of family medicine. In this case, this study was based on a behavioral approach, for which more experienced family physicians could have made the we attached high value to an easy-to-perform method. difference in the intervention method. Previous studies have shown that intervention methods As another consideration for devising a brief and easy- involving multiple approaches for weight reduction to-perform intervention method, we noted weight self- are more effective than those with a single approach monitoring. In a previous study, Butryn and colleagues [14, 38, 39]. Thus, to develop an effective intervention showed that more frequent body weight self-monitoring method for reducing body weight during short, primary is related to body weight maintenance in patients who Table 6 Comparison of weight change at the 1-year follow up between before and after the Great East Japan Earthquake Total Before the earthquake After the earthquake Intervention group Number of participants 9 9 18 Weight change (kg) −0.4 kg −0.7 kg −0.5 kg Control group Number of participants 11 11 22 Weight change (kg) −1.0 kg −0.6 kg −0.8 kg Total Number of participants 20 20 40 Weight change (kg) −0.7 kg −0.6 kg −0.7 kg Mean weight change between baseline and the 1-year follow up Kanke et al. Asia Pacific Family Medicine (2015) 14:5 Page 11 of 12 had lost weight [40]. Some researchers have proposed Competing interests Part of this study was financially supported by the Jinsenkai Public Interest that weight self-monitoring increases obese patients’ Incorporated Foundation. awareness of their weight and results in them modifying their eating and exercise behavior [41]. The result of Authors’ contributions ancillary analysis revealed the relationship between SK designed this study, analyzed data, and drafted the manuscript. TK participated in the analyses and drafted the manuscript. NT and YM carried self-monitoring frequency at baseline and body weight out participants’ intervention. AI carried out randomization of participants. RK reduction, as well as that between change in body weight supervised all the study process and reviewed the manuscript. All authors self-monitoring frequency and body weight reduction. read and approved the final manuscript. We,therefore,considerit worthwhile to explorethis relationship further in a future prospective study. Acknowledgement We thank Kimie Iizuka, Tomoko Yoshida, and Emiko Furukawa for their This study has several limitations. First, it was con- assistance in measuring patient parameters. We are also grateful to all the ducted at a single family medicine clinic, where it was participants in this study. difficult to analyze subjects by sex, age, and other factors Author details due to the number of eligible patients. If the number of Department of Community and Family Medicine, Fukushima Medical participants had been larger, we might detect modest University, 1 Hikarigaoka, Fukushima City, Fukushima Prefecture, Japan. weight reduction. And if the observation period had Department of Internal Medicine, Kashima Hospital, 22-1 Shimokuramochi Nakasawame, Kashima-machi, Iwaki City, Fukushima Prefecture, Japan. been longer, we might detect long-term weight change. 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Asia Pacific Family MedicineSpringer Journals

Published: May 21, 2015

References