Behavior Change Family Counseling to Reduce Rate of Weight Gain in At-Risk Children
Condition: Cardiovascular Diseases; Heart Diseases; Obesity
MeSH terms: Cardiovascular Diseases; Heart Diseases; Obesity
Study type: Interventional

Summary: 
      This study will train primary care providers to counsel families on behavior change that is
      aimed at reducing the rate of weight gain in at-risk children.
    

Detailed description: 
      BACKGROUND:

      In addition to family, school, and community, primary care is a promising setting for
      childhood obesity prevention. However, most pediatric primary care providers are not trained
      to deliver behavior modification interventions and, according to preliminary data, are less
      likely to address obesity prevention when they perceive insufficient time during well-care
      visits.

      DESIGN NARRATIVE:

      This is a controlled study of obesity prevention, with group randomization of two
      standardized 12-month intervention strategies at the practice level. The intervention
      strategies are based on the behavioral economics theory and will be delivered by primary care
      providers after training in behavior modification. The first strategy will target change in
      multiple behaviors, while the second strategy will target only one behavior (beverage
      consumption). These two interventions will be compared to an active control intervention that
      is unrelated to weight (bullying prevention). Six to seven primary care practices will be
      randomized to each arm with 21 patients per practice, for a total of 17 practices and 350
      patients. The primary aim is to demonstrate that either obesity prevention intervention will
      result in less body mass index (BMI) increase (adjusted using z-score) in children age 8 to
      12 years who are at risk for overweight (BMI 50th-95th percentile), as compared to a control
      intervention. The study also hypothesizes that the multiple-behavior intervention, the
      single-behavior intervention, or both will result in less adjusted BMI increase than the
      control intervention at 24 months post-randomization, with no a priori assumption in
      differences between the two obesity prevention strategies. Blood pressure, insulin
      resistance, dyslipidemia, and oral health status will be secondary outcomes. Intermediate
      behavioral outcomes and process data will be collected.
    

Intervention name(s): Single behavior intervention; Multiple behavior interventions; Control Intervention unrelated to weight
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Focused on changing beverage choices which may have a significant impact on weight.; Focused on multiple behaviors (nutrition, beverages, physical activity, and sedentary lifestyle) which may have a significant impact on weight.; Focused on standard intervention strategies unrelated to weight including bullying prevention.
Other intervention name(s): Focused on changing beverage choices with the goal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention