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A Randomized Controlled Trial

Denise E. Wilfley, PhD; Richard I. Stein, PhD; Brian E. Saelens, PhD; Danyte S. Mockus, MPH; Georg E. Matt, PhD; Helen A. Hayden-Wade, PhD; R. Robinson Welch, PhD; Kenneth B. Schechtman, PhD; Paul A. Thompson, PhD; Leonard H. Epstein, PhD

JAMA. 2007;298:1661-1673.

Context  No trials for childhood overweight have examined maintenance interventions to augment the effects of initial weight loss programs.

Objectives  To determine the short-term and long-term efficacy of 2 distinct weight maintenance approaches vs no continued treatment control following standard family-based behavioral weight loss treatment for childhood overweight, and to examine children's social functioning as a moderator of outcome.

Design, Setting, and Participants  A parallel-group, randomized controlled trial conducted between October 1999 and July 2004 in a university-based weight control clinic. Participants were 204 healthy 7- to 12-year-olds, 20% to 100% above median body mass index (BMI) for age and sex, with at least 1 overweight parent. Children enrolled in 5 months of weight loss treatment and 150 were randomized to 1 of 3 maintenance conditions. Follow-up assessments occurred immediately following maintenance treatments and 1 and 2 years following randomization.

Interventions  Maintenance conditions included the control group or 4 months of behavioral skills maintenance (BSM) or social facilitation maintenance (SFM) treatment.

Main Outcome Measures  BMI z score and percentage overweight.

Results  Children receiving either BSM or SFM maintained relative weight significantly better than children assigned to the control group from randomization to postweight maintenance (P.01 for all; effect sizes d = 0.72-0.96; mean changes in BMI z scores = –0.04, –0.04, –0.05, and 0.05 for BSM alone, SFM alone, BSM and SFM together, and the control group, respectively). Active maintenance treatment efficacy relative to the control group declined during follow-up, but the effects of SFM alone (P = .03; d = 0.45; mean change in BMI z score = –0.24) and when analyzed together with BSM (P = .04; d = 0.38; mean change in BMI z score = –0.22) were significantly better than the control group (mean change in BMI z score = –0.06) when examining BMI z score outcomes from baseline to 2-year follow-up. Baseline child social problem scores moderated child relative weight change from baseline to 2-year follow-up, with low social problem children in SFM vs the control group having the best outcomes.

Conclusions  The addition of maintenance-targeted treatment improves short-term efficacy of weight loss treatment for children relative to no maintenance treatment. However, the waning of effects over follow-up, although moderated by child initial social problems, suggests the need for the bolstering of future maintenance treatments to sustain effects.

Trial Registration  clinicaltrials.gov Identifier: NCT00301197

Author Affiliations: Departments of Psychiatry (Drs Wilfley and Welch), Internal Medicine (Dr Stein), and Biostatistics (Drs Schechtman and Thompson), Washington University School of Medicine, St Louis, Missouri; Department of Pediatrics, University of Washington and Children's Hospital and Regional Medical Center, Seattle (Dr Saelens); Joint Doctoral Programs in Epidemiology (Ms Mockus) and Clinical Psychology (Dr Matt), San Diego State University, San Diego, California; Child and Adolescent Services Research Center, San Diego, California (Dr Hayden-Wade); and Departments of Pediatrics and Social and Preventive Medicine, University of Buffalo, Buffalo, New York (Dr Epstein).

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