Health4Kids Intervention Trial for Hispanic Families
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The H4K Trial is a randomized controlled trial to improve children's body composition by
      testing a comprehensive, culturally and linguistically relevant, family-oriented intervention
      for overweight and obese Hispanic children (ages 6-11) in three pediatric clinics in San
      Antonio, Texas. The H4K trial will test the efficacy of a 6-month pediatric obesity
      management intervention (physician counseling plus telephone counseling, newsletters and text
      messages) compared to standard care (physician counseling only) on three outcomes: 1) body
      composition (i.e., waist circumference, weight and z-BMI); 2) insulin, glucose and
      cholesterol levels; and 3) behavior change in physical activity (PA), sedentary behavior and
      consumption of sugary beverages and fruits and vegetables. The investigators will recruit 230
      overweight and obese children-and a parent or guardian for each-and randomize them to the H4K
      intervention (n = 115 child/parent dyads) or standard care (n = 115 child/parent dyads). The
      investigators hypothesize that intervention children will significantly improve their body
      composition, increased their PA levels and diet quality (more fruits and vegetables and less
      sugary beverages), and decrease their sedentary activity, compared to children in standard
      care. If successful, this study will generate new scientific knowledge about effective
      Hispanic family-based approaches for obesity prevention with high potential for replication
      in underserved areas across the nation.
    

Detailed description: 
      Given the continuing rise of the U.S. Hispanic population, reversing the Hispanic childhood
      obesity epidemic is critical to the nation's future health. Mexican American children and
      those from socioeconomically disadvantaged families often are far more overweight and obese
      than their peers, heightening their risk for obesity-related health complications. Our
      proposed randomized controlled trial, the Health4Kids (H4K) Trial for Hispanic Families, aims
      to improve Hispanic children's body composition by testing a comprehensive, culturally and
      linguistically relevant, family-oriented intervention for overweight and obese (body mass
      index (BMI) between the 85th and 99.9thth (<99th) percentile for age and gender) Hispanic
      children ages 6-11 in pediatric clinics in San Antonio, Texas, a largely Hispanic city. Our
      team, formed during our pilot research funded by the Centers for Medicare and Medicaid
      Services (1H0CMS030457), unites academic investigators and community partners with experience
      working together to conduct behavioral and clinical interventions and outreach with
      Hispanics. The H4K trial will test the efficacy of a 6-month pediatric obesity management
      intervention (physician counseling plus telephone counseling, newsletters and text messages)
      compared to standard care (physician counseling only) on three outcomes: 1) body composition
      (i.e., waist circumference, weight and z-BMI); 2) insulin, glucose and cholesterol levels;
      and 3) behavior change in physical activity (PA), sedentary behavior and consumption of
      sugary beverages and fruits and vegetables. We will recruit 230 overweight and obese
      children-and a parent or guardian for each-and randomize them to the POM intervention (n =
      115 child/parent dyads) or standard care (n = 115 child/parent dyads). From a baseline, we
      will measure the impact of the trial on the primary outcome (body composition) and secondary
      outcomes (insulin, glucose and cholesterol levels and several specific health behavior
      changes) at 1 month, 6 and 12 months post-randomization. We also will evaluate the critical
      role of parenting strategies and changes in the home environment as mediators of intervention
      effects. We hypothesize that intervention children will significantly improve their body
      composition, increased their PA levels and diet quality (more fruits and vegetables and less
      sugary beverages), and decrease their sedentary activity, compared to children in standard
      care. If successful, this study will generate new scientific knowledge about effective
      Hispanic family-based approaches for obesity prevention with high potential for replication
      in underserved areas across the nation.
    

Intervention name(s): behavioral counseling; Education Materials; Face to face counseling session; Text messages; Telephone Counseling; Newsletters
Intervention type(s): Behavioral; Other; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Pediatrician trained in motivational interviewing techniques provides brief lifestyle behavioral counseling to child and parent using a Healthy Lifestyle Prescription; Health education materials about healthy eating and physical activity and a community resource guide; 30 minute face-to-face family-centered behavioral counseling session delivered by a health educator; regularly scheduled cell phone text messages for 12 months; 14 telephone counseling sessions delivered by a health educator using motivational interviewing techniques. Two sessions per month for the first two months followed by one session per month for 10 months; 12 monthly newsletters mailed to participant homes
Other intervention name(s): SMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hispanic; overweight; families; pediatric; primary care