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Effect of Behavioral Therapy With In-Clinic or Telephone Group Visits vs In-Clinic Individual Visits on Weight Loss Among Patients With Obesity in Rural Clinical Practice: A Randomized Clinical Trial.
Befort, CA, VanWormer, JJ, Desouza, C, Ellerbeck, EF, Gajewski, B, Kimminau, KS, Greiner, KA, Perri, MG, Brown, AR, Pathak, RD, et al
JAMA. 2021;(4):363-372
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IMPORTANCE Rural populations have a higher prevalence of obesity and poor access to weight loss programs. Effective models for treating obesity in rural clinical practice are needed. OBJECTIVE To compare the Medicare Intensive Behavioral Therapy for Obesity fee-for-service model with 2 alternatives: in-clinic group visits based on a patient-centered medical home model and telephone-based group visits based on a disease management model. DESIGN, SETTING, AND PARTICIPANTS Cluster randomized trial conducted in 36 primary care practices in the rural Midwestern US. Inclusion criteria included age 20 to 75 years and body mass index of 30 to 45. Participants were enrolled from February 2016 to October 2017. Final follow-up occurred in December 2019. INTERVENTIONS All participants received a lifestyle intervention focused on diet, physical activity, and behavior change strategies. In the fee-for-service intervention (n = 473), practice-employed clinicians provided 15-minute in-clinic individual visits at a frequency similar to that reimbursed by Medicare (weekly for 1 month, biweekly for 5 months, and monthly thereafter). In the in-clinic group intervention (n = 468), practice-employed clinicians delivered group visits that were weekly for 3 months, biweekly for 3 months, and monthly thereafter. In the telephone group intervention (n = 466), patients received the same intervention as the in-clinic group intervention, but sessions were delivered remotely via conference calls by centralized staff. MAIN OUTCOMES AND MEASURES The primary outcome was weight change at 24 months. A minimum clinically important difference was defined as 2.75 kg. RESULTS Among 1407 participants (mean age, 54.7 [SD, 11.8] years; baseline body mass index, 36.7 [SD, 4.0]; 1081 [77%] women), 1220 (87%) completed the trial. Mean weight loss at 24 months was -4.4 kg (95% CI, -5.5 to -3.4 kg) in the in-clinic group intervention, -3.9 kg (95% CI, -5.0 to -2.9 kg) in the telephone group intervention, and -2.6 kg (95% CI, -3.6 to -1.5 kg) in the in-clinic individual intervention. Compared with the in-clinic individual intervention, the mean difference in weight change was -1.9 kg (97.5% CI, -3.5 to -0.2 kg; P = .01) for the in-clinic group intervention and -1.4 kg (97.5% CI, -3.0 to 0.3 kg; P = .06) for the telephone group intervention. CONCLUSIONS AND RELEVANCE Among patients with obesity in rural primary care clinics, in-clinic group visits but not telephone-based group visits, compared with in-clinic individual visits, resulted in statistically significantly greater weight loss at 24 months. However, the differences were small in magnitude and of uncertain clinical importance. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02456636.
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Effect of Surgical Versus Medical Therapy on Diabetic Kidney Disease Over 5 Years in Severely Obese Adolescents With Type 2 Diabetes.
Bjornstad, P, Hughan, K, Kelsey, MM, Shah, AS, Lynch, J, Nehus, E, Mitsnefes, M, Jenkins, T, Xu, P, Xie, C, et al
Diabetes care. 2020;(1):187-195
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OBJECTIVE To compare diabetic kidney disease (DKD) rates over 5 years of follow-up in two cohorts of severely obese adolescents with type 2 diabetes (T2D) undergoing medical or surgical treatment for T2D. RESEARCH DESIGN AND METHODS A secondary analysis was performed of data collected from obese participants of similar age and racial distribution enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and the Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY) studies. Teen-LABS participants underwent metabolic bariatric surgery (MBS). TODAY participants were randomized to metformin alone or in combination with rosiglitazone or intensive lifestyle intervention, with insulin therapy given for glycemic progression. Glycemic control, BMI, estimated glomerular filtration rate (eGFR), urinary albumin excretion (UAE), and prevalence of hyperfiltration (eGFR ≥135 mL/min/1.73 m2) and elevated UAE (≥30 mg/g) were assessed annually. RESULTS Participants with T2D from Teen-LABS (n = 30, mean ± SD age, 16.9 ± 1.3 years; 70% female; 60% white; BMI 54.4 ± 9.5 kg/m2) and TODAY (n = 63, age 15.3 ± 1.3 years; 56% female; 71% white; BMI 40.5 ± 4.9 kg/m2) were compared. During 5 years of follow-up, hyperfiltration decreased from 21% to 18% in Teen-LABS and increased from 7% to 48% in TODAY. Elevated UAE decreased from 27% to 5% in Teen-LABS and increased from 21% to 43% in TODAY. Adjusting for baseline age, sex, BMI, and HbA1c, TODAY participants had a greater odds of hyperfiltration (odds ratio 15.7 [95% CI 2.6, 94.3]) and elevated UAE (27.3 [4.9, 149.9]) at 5 years of follow-up. CONCLUSIONS Compared with MBS, medical treatment of obese youth with T2D was associated with a higher odds of DKD over 5 years.
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DXA-assessed changes in body composition in obese women following two different weight loss programs.
Ponti, F, Soverini, V, Plazzi, A, Aparisi Gómez, MP, Mercatelli, D, Guglielmi, G, Battista, G, Marchesini, G, Bazzocchi, A
Nutrition (Burbank, Los Angeles County, Calif.). 2018;:13-19
Abstract
OBJECTIVE Changes in body composition during weight loss programs might have a significant effect on long-term results. The aim of this study was to test these changes by dual energy x-ray absorptiometry (DXA) in obese women enrolled into two different weight loss medical programs. METHODS We prospectively studied 71 women assigned to either an intensive 3-mo cognitive-behavioral therapy (CBT) or a 1-mo nutritional counseling plan (NCP). All patients underwent DXA whole-body scan before treatment and after 3, 6, and 12 mo. Fat mass (FM), non-bone lean mass (LM) and bone mineral content were assessed at whole-body and regional levels. Android visceral adipose tissue (VAT) also was estimated. RESULTS Twenty-three patients missed one or more follow-up controls and were excluded from the final analysis. Twenty-seven patients (body mass index [BMI] 41.9 ± 6.7 kg/m2) remained in the CBT group and 21 (BMI 33.4 ± 4 kg/m2) in the NCP group. The progressive decrease of BMI in both groups was associated with reduced whole-body and regional FM, which was more marked in CBT. During follow-up, a progressive decrease of total FM-to-LM and android FM-to-LM ratios were observed both in CBT (Δ12-mo versus baseline -7.8 ± 9.6% and -9.5 ± 12.7%, respectively; P < 0.01) and NCP (Δ12-mo versus baseline -5.9 ± 9.6% and -7 ± 13.4%, respectively; P < 0.05). VAT was the parameter showing the largest decrease (-14.2 ± 17.4% and -11.3 ± 18.2% at 12 mo, respectively in CBT and NCP; P < 0.05). CONCLUSIONS Lifestyle-induced weight loss is associated with selective changes in body composition parameters, regardless of initial BMI and treatment program, limiting sarcopenic obesity. DXA may quantify the metabolically healthier redistribution of total and regional FM and VAT.
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Diabetes Prevention Program Translation in the Veterans Health Administration.
Moin, T, Damschroder, LJ, AuYoung, M, Maciejewski, ML, Datta, SK, Weinreb, JE, Steinle, NI, Billington, C, Hughes, M, Makki, F, et al
American journal of preventive medicine. 2017;(1):70-77
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INTRODUCTION This clinical demonstration trial compared the effectiveness of the Veterans Affairs Diabetes Prevention Program (VA-DPP) with an evidence-based usual care weight management program (MOVE!®) in the Veterans Health Administration health system. DESIGN Prospective, pragmatic, non-randomized comparative effectiveness study of two behavioral weight management interventions. SETTING/PARTICIPANTS Obese/overweight Veterans with prediabetes were recruited from three geographically diverse VA sites between 2012 and 2014. INTERVENTION VA-DPP included 22 group-based intensive lifestyle change sessions. MAIN OUTCOME MEASURES Weight change at 6 and 12 months, hemoglobin A1c (HbA1c) at 12 months, and VA health expenditure changes at 15 months were assessed using VA electronic health record and claims data. Between- and within-group comparisons for weight and HbA1c were done using linear mixed-effects models controlling for age, gender, race/ethnicity, baseline outcome values, and site. Analyses were conducted in 2015-2016. RESULTS A total of 387 participants enrolled (273 VA-DPP, 114 MOVE!). More VA-DPP participants completed at least one (73.3% VA-DPP vs 57.5% MOVE! p=0.002); four (57.5% VA-DPP vs 42.5% MOVE!, p=0.007); and eight or more sessions (42.5% VA-DPP vs 31% MOVE!, p=0.035). Weight loss from baseline was significant at both 6 (p<0.001) and 12 months (p<0.001) for VA-DPP participants, but only significant at 6 months for MOVE! participants (p=0.004). Between groups, there were significant differences in 6-month weight loss (-4.1 kg VA-DPP vs -1.9 kg MOVE!, p<0.001), but not 12-month weight loss (-3.4 kg VA-DPP vs -2.0 kg MOVE!, p=0.16). There were no significant differences in HbA1c change or outpatient, inpatient, and total VA expenditures. CONCLUSIONS VA-DPP participants had higher participation rates and weight loss at 6 months, but similar weight, HbA1c, and health expenditures at 12 months compared to MOVE! PARTICIPANTS Features of VA-DPP may help enhance the capability of MOVE! to reach a larger proportion of the served population and promote individual-level weight maintenance.
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Randomized trial comparing group size of periodic in-person sessions in a remotely delivered weight loss intervention.
Tate, DF, Valle, CG, Crane, MM, Nezami, BT, Samuel-Hodge, CD, Hatley, KE, Diamond, M, Polzien, K
The international journal of behavioral nutrition and physical activity. 2017;(1):144
Abstract
BACKGROUND Few randomized studies have examined differential effects of group size in behavioral weight control, especially in hybrid programs that include Internet treatment approaches. METHODS Randomized controlled trial (n = 195) comparing a 4 month hybrid internet weight loss program coupled with monthly face to face groups of 100 persons (Large Group, LG; 1 group) or to the same approach with monthly groups of 20 persons (Small Group, SG; 4 groups). Repeated-measures mixed-model analysis with age and race as covariates were used to estimate primary (weight) and secondary outcomes, and to test group differences in change over time. RESULTS The sample was 46.3 years old ±10.4, 90.3% female, and 51.9% non-white, with BMI 37.9 ± 8.4 kg/m2. Participants in the LG were more likely to return for the 4-month assessment visit than those in the SG (p = 0.04). Participants randomized to both the LG and SG conditions experienced significant WL over time (no between group difference: -4.1 kg and -3.7 kg, respectively) and weight loss was positively associated with attendance at monthly meetings and logins to the website. Satisfaction with the program was high and similar in both groups (94.4% reported that they were "satisfied" or "very satisfied"). CONCLUSIONS Using a hybrid approach of in-person and online weight loss interventions may be an effective way to reach larger and more diverse populations. Delivering the face to face component of the intervention in groups larger than those traditionally delivered (20-25 people) could increase the cost-effectiveness of group-based behavioral weight loss interventions. CLINICAL TRIALS REGISTRATION NUMBER NCT01615471 . Registered June 6, 2012. Registered retrospectively.
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Enhancement of Self-Monitoring in a Web-Based Weight Loss Program by Extra Individualized Feedback and Reminders: Randomized Trial.
Hutchesson, MJ, Tan, CY, Morgan, P, Callister, R, Collins, C
Journal of medical Internet research. 2016;(4):e82
Abstract
BACKGROUND Self-monitoring is an essential behavioral strategy for effective weight loss programs. Traditionally, self-monitoring has been achieved using paper-based records. However, technology is now more frequently used to deliver treatment programs to overweight and obese adults. Information technologies, such as the Internet and mobile phones, allow innovative intervention features to be incorporated into treatment that may facilitate greater adherence to self-monitoring processes, provide motivation for behavior change, and ultimately lead to greater weight loss success. OBJECTIVE The objective of our study was to determine whether the consistency of self-monitoring differed between participants randomly assigned to a basic or an enhanced 12-week commercial Web-based weight loss program. METHODS We randomly assigned a sample of 301 adults (mean age 42.3 years; body mass index 31.3 kg/m2; female 176/301, 58.5%) to the basic or enhanced group. The basic program included tools for self-monitoring (online food and exercise diary, and a weekly weigh-in log) with some feedback and reminders to weigh in (by text or email). The enhanced program included the basic components, as well as extra individualized feedback on self-monitoring entries and reminders (by text, email, or telephone) to engage with self-monitoring tools. We evaluated the level of self-monitoring by examining the consistency of self-monitoring of food, exercise, and weight during the 12 weeks. Consistency was defined as the number of weeks during which participants completed a criterion number of entries (ie, ≥3 days of online food or exercise diary records per week and ≥1 weigh-in per week). RESULTS The enhanced group's consistency of use of self-monitoring tools was significantly greater than that of the basic group throughout the 12 weeks (median consistency for food 8 vs 3 weeks, respectively, P<.001; for exercise 2.5 vs 1 weeks, respectively, P=.003). CONCLUSIONS Enhanced features, including additional individualized feedback and reminders, are effective in enhancing self-monitoring behaviors in a Web-based weight loss program. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12610000197033; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=335159 (Archived by WebCite at http://www.webcitation.org/6gCQdj21G).
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Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus.
Goday, A, Bellido, D, Sajoux, I, Crujeiras, AB, Burguera, B, García-Luna, PP, Oleaga, A, Moreno, B, Casanueva, FF
Nutrition & diabetes. 2016;(9):e230
Abstract
UNLABELLED Brackground:The safety and tolerability of very low-calorie-ketogenic (VLCK) diets are a current concern in the treatment of obese type 2 diabetes mellitus (T2DM) patients. OBJECTIVE Evaluating the short-term safety and tolerability of a VLCK diet (<50 g of carbohydrate daily) in an interventional weight loss program including lifestyle and behavioral modification support (Diaprokal Method) in subjects with T2DM. METHODS Eighty-nine men and women, aged between 30 and 65 years, with T2DM and body mass index between 30 and 35 kg m(-)(2) participated in this prospective, open-label, multi-centric randomized clinical trial with a duration of 4 months. Forty-five subjects were randomly assigned to the interventional weight loss (VLCK diet), and 44 to the standard low-calorie diet. RESULTS No significant differences in the laboratory safety parameters were found between the two study groups. Changes in the urine albumin-to-creatinine ratio in VLCK diet were not significant and were comparable to control group. Creatinine and blood urea nitrogen did not change significantly relative to baseline nor between groups. Weight loss and reduction in waist circumference in the VLCK diet group were significantly larger than in control subjects (both P<0.001). The decline in HbA1c and glycemic control was larger in the VLCK diet group (P<0.05). No serious adverse events were reported and mild AE in the VLCK diet group declined at last follow-up. CONCLUSIONS The interventional weight loss program based on a VLCK diet is most effective in reducing body weight and improvement of glycemic control than a standard hypocaloric diet with safety and good tolerance for T2DM patients.
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A comparison of a behavioral weight loss program to a stress management program: A pilot randomized controlled trial.
Webber, KH, Casey, EM, Mayes, L, Katsumata, Y, Mellin, L
Nutrition (Burbank, Los Angeles County, Calif.). 2016;(7-8):904-9
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OBJECTIVES This study compared a behavioral weight loss program (BWL) with a stress management-based program, Emotional Brain Training (EBT), on weight loss, blood pressure, depression, perceived stress, diet, and physical activity. METHODS Subjects with a body mass index (BMI) of >28 and <45 kg/m(2) were recruited in Lexington, Kentucky in January 2014 and randomized to BWL or EBT for a 20-week intervention. Of those recruited, 49 participants were randomized to EBT or BWL. Randomization and allocation to group were performed using SPSS software. Weight, blood pressure, depression, perceived stress, dietary intake, and physical activity were measured at baseline, 10 week, and 20 week. Linear models for change over time were fit to calculate 95% confidence intervals of intervention effects. RESULTS BWL produced greater changes in BMI than EBT at both 10 (P = 0.02) and 20 wk (P = 0.03). At 10 wk, both EBT and BWL improved BMI, systolic blood pressure, depression and perceived stress (P < 0.05). BWL also improved diastolic blood pressure (P = 0.005). At 20 wk, EBT maintained improvements in BMI, systolic blood pressure, depression, and perceived stress while BWL maintained improvements only in BMI and depression (P < 0.05). CONCLUSIONS BWL produced greater weight loss than EBT; however, EBT produced sustained improvements in stress, depression, and systolic blood pressure. A combination of the two approaches should be explored.
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A Randomized Comparative Effectiveness Trial for Preventing Type 2 Diabetes.
Ackermann, RT, Liss, DT, Finch, EA, Schmidt, KK, Hays, LM, Marrero, DG, Saha, C
American journal of public health. 2015;(11):2328-34
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OBJECTIVES We evaluated the weight loss effectiveness of a YMCA model for the Diabetes Prevention Program (DPP) lifestyle intervention. METHODS Between July 2008 and November 2010, we individually randomized 509 overweight or obese, low-income, nondiabetic adults with elevated blood glucose in Indianapolis, Indiana, to receive standard care plus brief lifestyle counseling or be offered a group-based YMCA adaptation of the DPP (YDPP). Primary outcome was mean weight loss difference at 12 months. In our intention-to-treat analyses, we used longitudinal linear or logistic regression, multiply imputing missing observations. We used instrumental variables regression to estimate weight loss effectiveness among participants completing 9 or more intervention lessons. RESULTS In the YDPP arm, 161 (62.6%) participants attended ≥ 1 lesson and 103 (40.0%) completed 9 or more lessons. In intention-to-treat analysis, mean 12-month weight loss was 2.3 kilograms (95% confidence interval [CI] = 1.1, 3.4 kg) more for the YDPP arm than for standard care participants. In instrumental variable analyses, persons attending 9 or more lessons had a 5.3-kilogram (95% CI = 2.8, 7.9 kg) greater weight loss than did those with standard care alone. CONCLUSIONS The YMCA model for DPP delivery achieves meaningful weight loss at 12 months among low-income adults.
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A web-based weight loss programme including breakfast cereals results in greater loss of body mass than a standardised web-based programme in a randomised controlled trial.
Ashwell, M, Howarth, E, Chesters, D, Allan, P, Hoyland, A, Walton, J
Obesity facts. 2014;(6):361-75
Abstract
OBJECTIVE To test the hypothesis that promoting breakfast cereal consumption, as part of a web-based programme, results in loss of body mass. METHODS Single centre, single blind, randomised parallel study. Test group followed a fully interactive website (B) with 'prescribed' breakfast cereals. Control group followed website (A) giving standard advice on weight loss.Study site visits at 0, 4, 12 and 24 weeks for measurements of height, weight, skinfolds, body fat, waist and hip circumference. 180 subjects were randomly allocated to two equal groups.Subjects were in good health and aged 19–50 years, with a BMI ranging from 25–40 kg/m 2 .At baseline there was no difference in mean age or BMI between the two groups. RESULTS The percentage change in body mass loss was greater when following website B than website A (n = 90; ITT repeated measures p = 0.013). For completers (website A: n = 62, website B: n= 64), the percentage change in body mass loss was also greater for website B than website A (repeated measures p = 0.023). CONCLUSION The advice and motivation offered by an interactive website, including provision and consumption of breakfast cereals, results in significantly greater loss of body mass compared to the use of a standard website. It is not possible to discern which of the three factors is responsible.