The prevalence of childhood overweight (CO) has tripled in recent decades, and related health care costs have quadrupled. While lifestyle interventions for CO have produced promising short-term results, a substantial percentage of children regain all or most of the relative weight they had lost. Indeed, results from our recent NICHD-funded randomized controlled trial (RCT) of CO maintenance interventions revealed that the benefits of treatment for all three groups (Behavioral Skills Maintenance-BSM;Social Facilitation Maintenance-SFM;and No Maintenance Treatment Control-NTC) began to attenuate once treatment contact was discontinued. However, SFM treatment proved superior to NTC in inducing long-term weight maintenance and demonstrated treatment-specific effects for psychosocial targets. Building on this positive finding, our proposed study will test the efficacy of SFM+ a version of SFM that is enhanced in both content and duration. Informed by learning theory and weight maintenance research, SFM + extends the duration of treatment from 4 months to 12 months to target a broad range of social environmental contexts across time with the objective of decreasing relapse. SFM+ also includes a focus on self-regulatory skills associated with successful weight maintenance. We propose to conduct a multi-site RCT with overweight children (N=240) and their parents to evaluate the effects of two doses of SFM + on weight loss maintenance at 12-month (post-treatment) and 18-month (6 months post-treatment) follow-up compared to a credible health education (CONTROL) condition. Participants will be randomized to one of three, 12-month treatment conditions: (1) low dose SFM+[LOW;26 sessions], (2) high dose SFM+ [HIGH;52 sessions], or (3) CONTROL [26 sessions]. The CONTROL condition matches the schedule, duration, and attention of the LOW condition, but differs in treatment content. The LOW and HIGH conditions are matched on content and duration, but differ in treatment dose. We will recruit a large, diverse sample from two different metropolitan areas and deliver high quality, innovative treatments in a standardized manner. We hypothesize that the HIGH condition will produce better weight maintenance and greater improvements in associated outcomes at 12 months and 18 months than either the LOW or the CONTROL conditions, and that the LOW condition will produce better weight maintenance than the CONTROL condition. This study is the first RCT to evaluate the core questions of content and dose for weight maintenance in children. By examining mediators and moderators, our study will also provide insight regarding how maintenance treatment works and for whom it is most effective. Identifying efficacious weight maintenance strategies will positively affect the health and well being of children, and inform public health approaches to the long-term management of CO.
Given the relapse among children with CO who do manage to lose weight, it is imperative to focus on weight loss maintenance to improve children's long-term health and achieve a reduction in adult obesity. Yet promoting successful, long-term weight strategies for children is challenging since contextual forces can serve to prompt or constrain the child's eating and activity choices. SFM+, based upon our previous promising findings, takes into account the complexity of these socio-environmental contexts by targeting support for, and practice of, weight maintaining behaviors across multiple levels (the child, the family, and with peers). We believe that our proposed stud is innovative in its translation of basic behavioral findings to the design of clinical intervention and its multi-level socio-environmental a roach to the problem of weight loss maintenance. In applying learning theory concepts to improve clinical weight maintenance treatment, this study is consistent with NIH priorities to foster collaboration between basic and clinical obesity research and will enhance our understanding about how basic learning principles affect behavioral outcomes. SFM+, with its focus on the familial and social context in which weight regain occurs, is a relevant and novel approach to pediatric weight loss maintenance. Our proposed application is the first RCT to systematically evaluate the core questions of treatment content and dose-response for weight maintenance in children. To date, there is a dearth of studies specifically examine weight loss maintenance treatments for children. This study is carefully designed to recruit a large, diverse sample from two different metropolitan areas and to deliver high quality, innovative treatments in a standardized manner. Although this study's focus is on efficacy, the proposed research provides important steps towards dissemination. For instance, if High SFM+ results in enduring weight maintenance, it will be more appealing and less costly to disseminate than approaches necessitating ongoing continued care. Once we have identified a robust efficacious treatment, future studies can address efficient methods to disseminate such treatment intercommunity settings. Therefore, the proposed study is in line with recommendations made at the 2007 NICHD-sponsored meeting, Beyond Individual Behavior: Multidimensional Research in Obesity Linking Biology to Society and is consistent with several NICHD goals: 1) preventing adolescent and adult disease that originates prenatally or in childhood;2) encouraging healthier lifestyles and prevention of diseases for the pediatric population;3) establishing a healthy physical and social environment;and 4) promoting the translation of research findings to make them disseminable, accessible, and useful to diverse audiences.
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