Healthy Children, Strong Families: American Indian Communities Preventing Obesity
Condition: Obesity; Overweight
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      Healthy Children, Strong Families-2 (HCSF-2) is a family focused early childhood intervention
      which addresses the growing problem of childhood obesity in American Indian communities. The
      study works with six rural and urban American Indian communities across the US to test the
      ability of the intervention to increase adoption of healthy lifestyles and to reduce the
      prevalence of obesity among preschool aged American Indian children and their primary
      caregivers - creating healthier children, healthier families and healthier communities. Our
      primary hypothesis is that children and their primary caregivers who receive the HCSF-2
      intervention will have better obesity related outcomes than those who do not receive HCSF-2.
    

Detailed description: 
      Intervention

      The Healthy Children, Strong Families-2 (HCSF-2) intervention consists of monthly mailed
      healthy lifestyle lessons (13 lessons) which will be dose enhanced with social networking
      support (cell-phone coaching with instant text messages and Facebook connections), as well as
      new intervention elements-stress and sleep. Social networking was chosen due to its
      widespread and ease of use, adaptability and potential for sustainability in the community.

      HCSF-2 is based on our hypothesis that working with children and their primary
      caregivers/parent to assist them in making healthy lifestyle changes is necessary to prevent
      excessive weight gain and risk of later lifestyle related chronic disease. Investigators will
      work with families at a critical time in their young child's physical and emotional
      development to encourage appropriate healthy lifestyle behaviors.

      This study will expand on our previous research to test the HCSF-2 intervention in a larger,
      more geographically and socially diverse sample of AI communities. The study also enhances
      the prior methodology through the inclusion of a social networking component. This research
      will address four key gaps in obesity prevention studies: families with preschool age
      children, social networking support, stress and sleep. Moreover, to our knowledge, this study
      will be the first family-based obesity intervention project for both rural and urban AI
      families. The potential impact of this study is high; if successful, this study will not only
      provide quantitative evidence of the effectiveness of the intervention but it will also give
      other investigators validated tools and procedures to collaboratively engage AI communities
      in health behavior change.

      Year 1, families will be randomized to start in the HCSF-2 intervention or an active control
      (mailed child safety newsletters). Then, in Year 2, intervention change will occur, such that
      HCSF-2 intervention families will receive the control safety lessons plus continued HCSF-2
      social networking, while control families will now receive the full HCSF-2 intervention.

      For example, families will be randomly assigned to begin in one of the two arms - denoted
      here as the HCSF-2 intervention (Phase A) or Child Safety intervention (Phase B).

      During the HCSF-2 intervention (Phase A) families will receive a monthly mailing with
      information about nutrition and physical activity, screen time, sleep and stress management.
      Families will also be invited to participate in a private Facebook group and will begin
      receiving wellness coaching text messages from the study.

      During the Child Safety intervention (Phase B) families will receive a monthly mailing with
      information about safety topics such as car safety, water safety, poisoning and home safety.

      After one year, families will flip into the second phase until the two year study period is
      complete. Families who began in Phase A will continue to receive wellness coaching text
      messages and have access to the private Facebook group. Families who began in Phase B will
      not receive wellness coaching text messages or have access to the private Facebook group
      until the flip into Phase A at the start of year two.

      This staggered enrollment design, chosen in conjunction with the participating communities,
      maximizes the contribution of each participating family, avoids the negative attitudes that
      would occur with a wait-list only control and ensures all families receive the intervention
      as desired by the participating tribal sites.

      This is a multi-site trial with up to six possible participating communities. Two sites will
      become active at the beginning of the intervention with remaining sites becoming active (and
      being added to the IRB protocol) at roughly 1 year intervals.

      A local site coordinator will be hired at each participating site. The local site coordinator
      will be responsible for recruiting participants, and conducting data collection visits. Site
      coordinators may also send wellness coaching text messages and post content to the private
      Facebook group.

      The UW program coordinator will be responsible for screening participants for eligibility,
      administering 24-hour dietary recalls by phone, mailing HCSF-2 curriculum materials and Child
      Safety materials, managing the entry and storage of study data, sending results letters to
      participants and supporting the community site coordinators.

      Methods

      Investigators will partner with 6 diverse rural and urban AI communities nationally to
      conduct a 2-arm staggered-enrollment randomized trial of an enhanced version of the HCSF
      intervention (HCSF-2) vs. active control (Child Safety intervention) in a 2-year design with
      outcomes measured at 0, 6, 12, 18 and 24 months. At the end of year 1, control families will
      receive HCSF-2, and HCSF-2 families will receive the control intervention with continued
      HCSF-2 social network support. Communities will work with us to enhance the family-focused
      HCSF-2 intervention to include novel methods of delivery (mailed lessons with social
      networking/cell phone text coaching) and two less-studied obesity determinants-sleep and
      stress-to increase impact and sustainability.

      Outcomes

      Primary outcomes will be body fat as assessed by child Body Mass Index z-score (zBMI) and
      adult Body Mass Index (BMI). Secondary outcomes include adult and child waist circumference,
      fruit/vegetable (FV) and added sugar intake, TV/screen time, activity, sleep, home
      environment changes, adult psychosocial factors (stress/depression) and social network use.

      Investigators will also identify key mediators of the effect of HCSF-2 on obesity and health
      behaviors. We hypothesize that modifiable behavior changes in children and caregivers, adult
      self-efficacy, social support and home environment changes are important mediators of the
      effect of the intervention on obesity and other outcomes. Investigators will develop and test
      exploratory mixed-effects regression models to investigate mediation on the path from HCSF-2
      to weight reduction.
    

Intervention name(s): Healthy Children, Strong Families; Child Safety
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Healthy Children, Strong Families is a series of 13 "lessons" mailed to primary caregivers of preschool aged children that provide education and activities related to obesity prevention. The lessons cover topics related to nutrition, physical activity, stress, sleep, and the home environment. Lessons include printed materials and small items (for example, an apple sectioner) that support activities in the lessons. Social support components via a monitored Facebook group and approximately semiweekly text messages sent to caregivers are included. The intervention spans 1 year.; The Child Safety intervention is an active control condition consisting of monthly two-page newsletters covering various topics relevant to child safety such as choking, car safety seats, bike and pedestrian safety. The intervention spans 1 year.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Obesity; Overweight; Lifestyle; American Indian