Familial Overweight: Comparing Use of Strategies
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of two different approaches (prescribed
      & self-directed) to the treatment of childhood obesity and their relative impact on child
      weight status, physical activity, and diet.
    

Detailed description: 
      Pediatric obesity is a highly prevalent problem, requiring both treatment and prevention
      efforts to reduce cardiovascular disease risk and metabolic consequences among affected
      children and the child population. The efficacy of family-based behavioral pediatric obesity
      treatment is likely compromised by non-optimal parent and child behavioral skills use (BSU).
      In pediatric obesity treatment trials, BSU assessment is infrequent, incomplete, and has
      unknown reliability. Poor and incomplete BSU measurement precludes improving behavioral
      interventions for pediatric obesity. Furthermore, different approaches to help families
      initiate and sustain BSU during and following treatment have not been tested. This study aims
      to investigate 1) prospective relations between BSU measured during and following treatment
      and change in child weight status, physical activity, and diet, and 2) differences in BSU
      trajectory between two different implementation approaches during and following treatment.
      Eighty-two parent-child (7-11 y.o.) pairs will participate in a 20-week treatment with
      follow-up at 3 and 6 months. Participants will be randomly assigned to receive either a
      prescriptive or self-directed implementation approach to family-based behavioral pediatric
      obesity treatment. BSU (monitoring, contingency management, environmental control) will be
      reported or assessed at pre-treatment, at the 5th, 10th, and 15th treatment sessions, at
      post-treatment and at the 3-month and 6-month follow-ups by the parent, interventionist, and
      supplemental evaluator. Prospective associations between BSU, measured multiple times and by
      multiple informant/formats, and change in child weight status (z-BMI) and weight-related
      behaviors (diet, physical activity) over the course of treatment and throughout follow up
      will be examined. This proposal will provide important information about the type of BSU and
      its measurement that is most related to short- and long-term treatment efficacy, and provide
      pilot data on the relative efficacy of different implementation approaches to initiate and
      sustain BSU in pediatric obesity intervention.
    

Intervention name(s): FOCUS
Intervention type(s): Behavioral
Intervention description(s): Treatment will be delivered over a 20-week period. Participating children and at least one of their parents will attend weekly in-person clinic sessions. Treatment will consist of 20-25 minute meetings between the assigned interventionist and each child/parent pair to individualize treatment, with an emphasis on helping the family change eating and activity behaviors. Family meetings will be followed by separate child and parent group meetings lasting approximately 35-45 minutes. In both approaches, parents serve as primary implementers of the treatment for the child and, if overweight, for themselves. Group sessions provide education in diet and physical activity, parenting, and behavioral skills, although conditions differ in whether skills are "prescribed" or "self-directed". Children and parents will be weighed at each clinic visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment