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Relationship between treatment preference and weight loss in the context of a randomized controlled trial.

ABSTRACT: Randomized controlled trials (RCTs) are considered the gold standard used to assess the efficacy of treatment. While a well implemented RCT can produce an unbiased estimate of the relative difference between treatment groups, the generalizability of these findings may be limited. Specific threats to the external validity include treatment preference. The purposes of this study were to: (i) assess whether receiving one's treatment preference was associated with weight loss and retention and (ii) whether receiving one's treatment preference modified the relationship between the treatments and weight loss. Treatment preference was assessed in 250 subjects prior to but independent of randomization into either low-carbohydrate or low-fat diets. Treatment preference was a predictor of weight loss (P = 0.002) but not retention (P = 0.90). Participants who received their preference lost less weight (-7.7 kg, 95% confidence interval (CI): -9.3 to -6.1) than participants who did not receive their preference (-9.7 kg, 95% CI: -11.4 to -8.1) and participants who did not report a strong preference at baseline (-11.2 kg, 95% CI: -12.6 to -9.7) (P = 0.04 and P = 0.0004, respectively). Treatment preference did not modify the effect of the treatment on weight loss. Contrary to conceptual predictions, this study failed to identify an interaction between treatment preference and weight loss in the setting of a randomized trial. Until treatment preference effects are definitively ruled out in this domain, future studies might consider stratifying their randomization procedure by treatment preference rather than excluding participants with strong treatment preferences.

SUBMITTER: Borradaile KE

PROVIDER: S-EPMC3819599 | biostudies-literature | 2012 Jun

REPOSITORIES: biostudies-literature

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Relationship between treatment preference and weight loss in the context of a randomized controlled trial.

Borradaile Kelley E KE Halpern Scott D SD Wyatt Holly R HR Klein Samuel S Hill James O JO Bailer Brooke B Brill Carrie C Stein Richard I RI Miller Bernard V BV Foster Gary D GD

Obesity (Silver Spring, Md.) 20110714 6

Randomized controlled trials (RCTs) are considered the gold standard used to assess the efficacy of treatment. While a well implemented RCT can produce an unbiased estimate of the relative difference between treatment groups, the generalizability of these findings may be limited. Specific threats to the external validity include treatment preference. The purposes of this study were to: (i) assess whether receiving one's treatment preference was associated with weight loss and retention and (ii) ...[more]

PMID: 21760633

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Project description:BACKGROUND:Social networks influence obesity patterns, but interventions to leverage social incentives to promote weight loss have not been well evaluated. OBJECTIVE:To test the effectiveness of gamification interventions designed using insights from behavioral economics to enhance social incentives to promote weight loss. DESIGN:The Leveraging Our Social Experiences and Incentives Trial (LOSE IT) was a 36-week randomized, controlled trial with a 24-week intervention and 12-week follow-up. PARTICIPANTS:One hundred and ninety-six obese adults (body mass index ≥ 30) comprising 98 two-person teams. INTERVENTIONS:All participants received a wireless weight scale, used smartphones to track daily step counts, formed two-person teams with a family member or friend, and selected a weight loss goal. Teams were randomly assigned to control or one of two gamification interventions for 36 weeks that used points and levels to enhance collaborative social incentives. One of the gamification arms also had weight and step data shared regularly with each participant's primary care physician (PCP). MAIN OUTCOME MEASURES:The primary outcome was weight loss at 24 weeks. Secondary outcomes included weight loss at 36 weeks. KEY RESULTS:At 24 weeks, participants lost significant weight from baseline in the control arm (mean: - 3.9 lbs; 95% CI: - 6.1 to - 1.7; P < 0.001), the gamification arm (mean: - 6.6 lbs; 95% CI: - 9.4 to - 3.9; P < 0.001), and the gamification arm with PCP data sharing (mean: - 4.8 lbs; 95% CI: - 7.4 to - 2.3; P < 0.001). At 36 weeks, weight loss from baseline remained significant in the control arm (mean: - 3.5 lbs; 95% CI: - 6.1 to - 0.8; P = 0.01), the gamification arm (mean: - 6.3 lbs; 95% CI: - 9.2 to - 3.3; P < 0.001), and the gamification arm with PCP data sharing (mean: - 5.2 lbs; 95% CI: - 8.5 to - 2.0; P < 0.01). However, in the main adjusted model, there were no significant differences in weight loss between each of the intervention arms and control at either 12, 24, or 36 weeks. CONCLUSIONS:Using digital health devices to track behavior with a partner led to significant weight loss through 36 weeks, but the gamification interventions were not effective at promoting weight loss when compared to control. TRIAL REGISTRATION:clinicaltrials.gov Identifier: 02564445.

Project description:BACKGROUND:Rising obesity levels remain a major public health concern due to the clear link with several comorbidities such as diabetes. Diabetes now affects 6% of the UK population. Modest weight loss of 5% to 10% has been shown to be associated with significant reductions in blood sugar, lipid, and blood pressure levels. Men have been shown to be attracted to programs that do not require extensive face-to-face time commitments, illustrating the potential audience available for health behavior change via the Web. OBJECTIVE:The objective of our study was to evaluate the feasibility and acceptability of a Web-based weight loss intervention in men with type 2 diabetes. METHODS:We conducted a pilot, parallel 2-arm, individually randomized controlled trial with embedded process evaluation. Participants were randomly assigned in a one-to-one ratio to the usual care group or the 12-month Web-based weight loss intervention, including dietitian and exercise expert feedback. Face-to-face recruitment and assessment were performed by the researcher unblinded. Data collected included weight, height, body mass index (BMI), and waist circumference, together with an audit trail of eligibility, recruitment, retention, and adherence rates. A process evaluation (website use data and qualitative interviews) monitored adherence, acceptability, and feasibility of the intervention. RESULTS:General practice database searches achieved the recruitment target (n=61) for the population of men with type 2 diabetes, of whom 66% (40/61) completed 3-month follow-up measurements. By 12 months, the retention rate was 52% (32/61), with 12 of the 33 men allocated to the intervention group still active on the website. The intervention was seen as acceptable by the majority of participants. We gained insights about acceptability and use of the website from the parallel process evaluation. CONCLUSIONS:Recruitment to the Web-based weight loss intervention was successful. Results are descriptive, but there were positive indications of increased weight loss (in kilograms and as a percentage), and reduced waist circumference and BMI for the intervention group from 3 to 12 months, in comparison with control. This research adds to the evidence base in relation to incorporating a Web-based weight loss intervention within the UK National Health Service (NHS). NHS weight loss services are struggling to provide sufficient referrals. Therefore, alternative modes of delivery, with the potential to reduce health professional input and time per patient while still enabling individual and tailored care, need to be investigated to identify whether they can be effective and thus benefit the NHS. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number (ISRCTN): 48086713; http://www.isrctn.com/ISRCTN48086713 (Archived by WebCite at http://www.webcitation.org/6rO4xSlhI).

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Relationship between treatment preference and weight loss in the context of a randomized controlled trial.

Publications

Relationship between treatment preference and weight loss in the context of a randomized controlled trial.

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