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Weight loss with self-help compared with a structured commercial program: a randomized trial
Heshka S, Anderson JW, Atkinson RL, Greenway FL, Hill JO, Phinney SD, Kolotkin RL, Miller-Kovach K, Pi-Sunyer FX
JAMA 2003 Apr;289(14):1792-1798
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

CONTEXT: Although commercial weight loss programs provide treatment to millions of clients, their efficacy has not been evaluated in rigorous long-term trials. OBJECTIVE: To compare weight loss and health benefits achieved and maintained through self-help weight loss versus with a structured commercial program. DESIGN AND SETTING: A 2-year, multicenter randomized clinical trial with clinic visits at 12, 26, 52, 78, and 104 weeks conducted at 6 academic research centers in the United States between January 1998 and January 2001. PARTICIPANTS: Overweight and obese men (n = 65) and women (n = 358) (body mass index 27 to 40) aged 18 to 65 years. INTERVENTION: Random assignment to either a self-help program (n = 212) consisting of two 20-minute counseling sessions with a nutritionist and provision of self-help resources or to a commercial weight loss program (n = 211) consisting of a food plan, an activity plan, and a cognitive restructuring behavior modification plan, delivered at weekly meetings. MAIN OUTCOME MEASURES: Weight change was the primary outcome measure. Secondary outcomes included waist circumference, body mass index, blood pressure, serum lipids, glucose, and insulin levels. RESULTS: At 2 years, 150 participants (71%) in the commercial group and 159 (75%) in the self-help group completed the study. In the intent-to-treat analysis, mean (SD) weight loss of participants in the commercial group was greater than in the self-help group at 1 year (-4.3 (6.1) kg versus -1.3 (6.1) kg, respectively; p < 0.001) and at 2 years (-2.9 (6.5) kg versus -0.2 (6.5) kg, respectively; p < 0.001). Waist circumference (p = 0.003) and body mass index (p < 0.001) decreased more in the commercial group. Changes in blood pressure, lipids, glucose, and insulin levels were related to changes in weight in both groups, but between-group differences in biological parameters were mainly nonsignificant by year 2. CONCLUSION: The structured commercial weight loss program provided modest weight loss but more than self-help over a 2-year period.

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