Growing Right Onto Wellness (GROW): Changing Early Childhood Body Mass Index (BMI) Trajectories
Condition: Overweight and Obesity; Childhood Obesity
MeSH terms: Obesity; Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to conduct a randomized controlled trial that examines how a
      family based, community centered intervention effects early childhood BMI trajectories.
    

Detailed description: 
      Increases in sedentary lifestyle and high calorie food consumption, among other factors, have
      contributed to epidemic levels of childhood obesity in the US. Children who are overweight
      during the preschool period are more likely to become overweight adolescents and obese
      adults. Food preferences and activity habits set in early childhood can profoundly influence
      lifelong trajectories for Body Mass Index (BMI) and health. Specifically, rapid BMI gain in
      early childhood has been established to affect adulthood mortality and morbidity.
      Unfortunately, the longer such unhealthy patterns are in place, the more difficult it can be
      to reverse them. Therefore, healthy lifestyle interventions targeted at children as early as
      preschool have enormous potential to affect lifelong health. Furthermore, nutrition and
      activity patterns are determined not only at the child level, but within the family and the
      community.

      This study will assess the impact of a family-based and community centered multilevel
      behavioral intervention addressing nutrition and physical activity with high risk
      parent-preschool children dyads to promote pediatric obesity prevention. The 7 year study
      will follow 600 parent preschool child dyads, half of whom will be randomized into the
      intervention condition which will utilize a health literate approach, build new social
      networks, utilize behavior modification tools including goal setting, self monitoring, and
      problem solving, and create behavior-environmental synergy with cues to action for use of the
      built environment for healthy behaviors. Both the intervention and control group (separately)
      will receive the control condition in which parent-child dyads will receive a literacy
      promotion/school success curriculum.

      The primary outcome of interest will be early childhood BMI trajectories measured at multiple
      time points over the three year RCT. Additional measures collected throughout the study from
      children and parents will include: tricep skin fold, waist circumference, actigraphy, 3-day
      diet recalls, questionnaires, social network data, and saliva to assess a
      genetics/epigenetics associated with obesity. Consistent with a multilevel systems approach,
      the investigators will develop and assess built environment changes related to obesity
      prevention. Moreover, working with the study's community partners, the investigators will
      evaluate how this approach affects local policy.
    

Intervention name(s): GROW Healthier; GROW Smarter
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Group sessions that meet once weekly for 3 months (intensive phase) with choice of phone call session as preferred by participant, phone call coaching monthly for 9 months (maintenance phase), and monthly cues to action to use one's built environment for healthy activities for 24 months (sustainability phase); Group sessions that meet six times over the course of three years with quarterly newsletters.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention