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Effect of a stepped-care intervention approach on weight loss in adults: a randomized clinical trial.

ABSTRACT: CONTEXT:Given the obesity epidemic, effective but resource-efficient weight loss treatments are needed. Stepped-treatment approaches customize interventions based on milestone completion and can be more effective while costing less to administer than conventional treatment approaches. OBJECTIVE:To determine whether a stepped-care weight loss intervention (STEP) compared with a standard behavioral weight loss intervention (SBWI) would result in greater weight loss. DESIGN, SETTING, AND PARTICIPANTS:A randomized clinical trial of 363 overweight and obese adults (body mass index: 25-<40; age: 18-55 years, 33% nonwhite, and 83% female) who were randomized to SBWI (n = 165) or STEP (n = 198) at 2 universities affiliated with academic medical centers in the United States (Step-Up Study). Participants were enrolled between May 2008 and February 2010 and data collection was completed by September 2011. INTERVENTIONS:All participants were placed on a low-calorie diet, prescribed increases in physical activity, and attended group counseling sessions ranging from weekly to monthly during an 18-month period. The SBWI group was assigned to a fixed program. Counseling frequency, type, and weight loss strategies could be modified every 3 months for the STEP group in response to observed weight loss as it related to weight loss goals. MAIN OUTCOME MEASURE:Mean change in weight over 18 months. Additional outcomes included resting heart rate and blood pressure, waist circumference, body composition, fitness, physical activity, dietary intake, and cost of the program. RESULTS:Of the 363 participants randomized, 260 (71.6%) provided a measure of mean change in weight over 18 months. The 18-month intervention resulted in weight decreasing from 93.1 kg (95% CI, 91.0 to 95.2 kg) to 85.6 kg (95% CI, 83.4 to 87.7 kg) (P < .001) in the SBWI group and from 92.7 kg (95% CI, 90.8 to 94.6 kg) to 86.4 kg (95% CI, 84.5 to 88.4 kg) in the STEP group (P < .001). The percentage change in weight from baseline to 18 months was -8.1% (95% CI, -9.4% to -6.9%) in the SBWI group (P < .001) compared with -6.9% (95% CI, -8.0% to -5.8%) in the STEP group (P < .001). Although the between-group difference in 18-month weight loss was not statistically different (-1.3 kg [95% CI, -2.8 to 0.2 kg]; P = .09), there was a significant group × time interaction effect (P = .03). The cost per participant was $1357 (95% CI, $1272 to $1442) for the SBWI group vs $785 (95% CI, $739 to $830) for the STEP group (P < .001). Both groups had significant and comparable improvements in resting heart rate, blood pressure level, and fitness. CONCLUSIONS:Among overweight and obese adults, the use of SBWI resulted in a greater mean weight loss than STEP over 18 months. Compared with SBWI, STEP resulted in clinically meaningful weight loss that cost less to implement. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00714168.

SUBMITTER: Jakicic JM

PROVIDER: S-EPMC4132634 | biostudies-literature | 2012 Jun

REPOSITORIES: biostudies-literature

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Effect of a stepped-care intervention approach on weight loss in adults: a randomized clinical trial.

Jakicic John M JM Tate Deborah F DF Lang Wei W Davis Kelli K KK Polzien Kristen K Rickman Amy D AD Erickson Karen K Neiberg Rebecca H RH Finkelstein Eric A EA

JAMA 20120601 24

<h4>Context</h4>Given the obesity epidemic, effective but resource-efficient weight loss treatments are needed. Stepped-treatment approaches customize interventions based on milestone completion and can be more effective while costing less to administer than conventional treatment approaches.<h4>Objective</h4>To determine whether a stepped-care weight loss intervention (STEP) compared with a standard behavioral weight loss intervention (SBWI) would result in greater weight loss.<h4>Design, setti ...[more]

PMID: 22735431

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Project description:ImportanceIdentifying effective weight loss interventions for Latino adults at risk of diabetes is of critical public health importance.ObjectiveTo determine whether a culturally adapted behavioral intervention for Latino adults was more effective than usual care for weight loss over 24 months.Design, setting, and participantsIn this randomized clinical trial, Latino adults with a body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 24 or greater and a high risk for type 2 diabetes were recruited in primary care practices in the San Francisco, California, area, randomized to receive the Vida Sana intervention or usual care, and followed up for 24 months. The study was conducted from November 2015 to May 2019, and data were analyzed from July 2019 to Septmeber 2020.InterventionsThe treatment group received Vida Sana, a culturally adapted lifestyle intervention that included a family-based orientation session and 22 group sessions over 12 months. Participants were encouraged to use a wearable activity tracker and mobile applications to track their physical activity and dietary intake. Participants received monthly email messages for an additional 12 months. The control group received usual care.Main outcomes and measuresThe primary outcome was weight loss at 24 months. Secondary outcomes included weight loss at 12 months and achieving at least 5% weight loss at 12 and 24 months. Associations of baseline characteristics and intervention adherence with weight loss outcomes were also examined.ResultsAmong 191 participants (mean [SD] age, 50.2 [12.2] years; 118 [61.8%] women; 107 participants [57.2%] of Mexican origin; mean [SD] baseline BMI, 32.4 [5.7]) randomized, 92 participants were randomized to the intervention and 99 participants were randomized to usual care. Of these, 185 participants (96.9%) completed 24-month follow-up. Mean (SD) weight loss did not differ significantly by group at 24 months (intervention: -1.1 [5.7] kg; control: -1.1 [7.1] kg; P = .93). However, mean (SD) weight loss was significantly greater in the intervention group (-2.6 [6.0] kg) than the control group (-0.3 [4.2] kg) at 12 months (mean difference, -2.1 [95% CI, -3.6 to -0.7] kg; P = .005). Intervention participants were more likely to achieve at least 5% weight loss than control participants at 12 months (22 participants [25.9%] vs 9 participants [9.2%]; P = .003), and participants who achieved at least 5% weight loss attended more intervention sessions than those who did not (mean [SD], 16.6 [7.6] sessions vs 12.4 [7.5] sessions; P = .03).Conclusions and relevanceThese findings suggest that among Latino adults with high diabetes risk, a culturally adapted behavioral lifestyle intervention was effective for weight loss over 12 months but not 24 months.Trial registrationClinicalTrials.gov Identifier: NCT02459691.

Project description:RationaleThe effect of weight loss on asthma in obese adults warrants rigorous investigation.ObjectivesTo examine an evidence-based, practical, and comprehensive lifestyle intervention targeting modest weight loss and increased physical activity for asthma control.MethodsThe trial randomized 330 obese adults with uncontrolled asthma to receive usual care enhanced with a pedometer, a weight scale, information about existing weight management services at the participating clinics, and an asthma education DVD, or with these tools plus the 12-month intervention.Measurements and main resultsThe primary outcome was change in Asthma Control Questionnaire (ACQ) scores from baseline to 12 months. Participants (mean [SD] age, 47.6 [12.4] yr) were 70.6% women, 20.0% non-Hispanic black, 20.3% Hispanic/Latino, and 8.2% Asian/Pacific Islander. At baseline, they were obese (mean [SD] body mass index, 37.5 [5.9] kg/m(2)) and had uncontrolled asthma (Asthma Control Test score, 15.1 [3.8]). Compared with control subjects, intervention participants achieved significantly greater mean weight loss (±SE) (intervention, -4.0 ± 0.8 kg vs. control, -2.1 ± 0.8 kg; P = 0.01) and increased leisure-time activity (intervention, 418.2 ± 110.6 metabolic equivalent task-min/wk vs. control, 178.8 ± 109.1 metabolic equivalent task-min/wk; P = 0.05) at 12 months. But between-treatment mean (±SE) differences were not significant for ACQ changes (intervention, -0.3 ± 0.1 vs. control, -0.2 ± 0.1; P = 0.92) from baseline (mean [SD], 1.4 [0.8]), nor for any other clinical asthma outcomes (e.g., spirometric results and asthma exacerbations). Among all participants regardless of treatment assignment, weight loss of 10% or greater was associated with a Cohen d effect of 0.76 and with 3.78 (95% confidence interval, 1.72-8.31) times the odds of achieving clinically significant reductions (i.e., ≥0.5) on ACQ as stable weight (<3% loss or gain from baseline). The effects of other weight change categories were small.ConclusionsModerately and severely obese adults with uncontrolled asthma can safely participate in evidence-based lifestyle intervention for weight loss and active living. The modest average weight and activity improvements are comparable to those shown to reduce cardiometabolic risk factors in studies of similar interventions in other populations but are not associated with significant net benefits for asthma control or other clinical asthma outcomes in the current population. Instead, weight loss of 10% or greater may be required to produce clinically meaningful improvement in asthma. Clinical trial registered with www.clinicaltrials.gov (NCT00901095).

Project description:The Diabetes Prevention Program (DPP) lifestyle intervention reduced the incidence of type 2 diabetes mellitus (DM) among high-risk adults by 58%, with weight loss as the dominant predictor. However, it has not been adequately translated into primary care.We evaluated 2 adapted DPP lifestyle interventions among overweight or obese adults who were recruited from 1 primary care clinic and had pre-DM and/or metabolic syndrome. Participants were randomized to (1) a coach-led group intervention (n = 79), (2) a self-directed DVD intervention (n = 81), or (3) usual care (n = 81). During a 3-month intensive intervention phase, the DPP-based behavioral weight-loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD. During the maintenance phase, participants in both interventions received lifestyle change coaching and support remotely-through secure email within an electronic health record system and the American Heart Association Heart360 website for weight and physical activity goal setting and self-monitoring. The primary outcome was change in body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) from baseline to 15 months.At baseline, participants had a mean (SD) age of 52.9 (10.6) years and a mean BMI of 32.0 (5.4); 47% were female; 78%, non-Hispanic white; and 17%, Asian/Pacific Islander. At month 15, the mean ± SE change in BMI from baseline was -2.2 ± 0.3 in the coach-led group vs -0.9 ± 0.3 in the usual care group (P < .001) and -1.6 ± 0.3 in the self-directed group vs usual care (P = .02). The percentages of participants who achieved the 7% DPP-based weight-loss goal were 37.0% (P = .003) and 35.9% (P = .004) in the coach-led and self-directed groups, respectively, vs 14.4% in the usual care group. Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose level.Proven effective in a primary care setting, the 2 DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact.clinicaltrials.gov Identifier: NCT00842426.

Project description:OBJECTIVE:To determine the effectiveness of a novel interdisciplinary treatment compared with usual care on weight loss in overweight and obese adult volunteers. DESIGN:Single blinded controlled trial. Participants randomly assigned to usual care (C, general guideline-based diet and exercise advice), intervention (I, interdisciplinary protocol) or intervention + a healthy food supplement (30 g walnuts/day) (IW). SETTING:Community based study, Illawarra region, south of Sydney, Australia. PARTICIPANTS:Generally well volunteer adult residents, 25-54 years, body mass index (BMI) 25-40kg/m2 were eligible. At baseline 439 were assessed, 377 were randomised, 298 completed the 3-month intensive phase and 178 completed the 12-month follow-up. INTERVENTIONS:Treatment was provided at clinic visits intensively (0 months, 1 month, 2 months, 3 months) then quarterly to 12 months. Support phone calls were quarterly. All participants underwent blinded assessments for diet, exercise and psychological status. PRIMARY AND SECONDARY MEASURES:The primary outcome was difference in weight loss between baseline and 12 months (clinically relevant target 5% loss). Secondary outcomes were changes in blood pressure, fasting blood glucose and lipids, and changes in diet, exercise and psychological parameters. RESULTS:At 12 months, differences in weight loss were identified (p<0.001). The I group lost more than controls at 3 months (91.11 (92.23,90.00), p<0.05) and the IW more than controls at 3 months (91.25 (92.35,90.15), p<0.05) and 6 months (92.20 (93.90,90.49), p<0.01). The proportion achieving 5% weight loss was significantly different at 3 months, 6 months and 9 months (p=0.04, p=0.03, p=0.03), due to fewer controls on target at 3 months, 6 months and 9 months and more IW participants at 6 months. Reductions in secondary outcomes (systolic blood pressure, blood glucose/lipid parameters and lifestyle measures) followed the pattern of weight loss. CONCLUSIONS:An interdisciplinary intervention produced greater and more clinically significant and sustained weight loss compared with usual care. The intensive phase was sufficient to reach clinically relevant targets, but long-term management plans may be required. TRIAL REGISTRATION NUMBER:ANZCTRN 12614000581662; Post-results.

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Effect of a stepped-care intervention approach on weight loss in adults: a randomized clinical trial.

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Effect of a stepped-care intervention approach on weight loss in adults: a randomized clinical trial.

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