Clinical trial NCT02343367: Health4Kids Intervention Trial for Hispanic Families
Official title: Pediatric Obesity Management Intervention Trial for Hispanic Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: Hispanic
overweight
families
pediatric
primary care
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: The University of Texas at San Antonio
name: Bexar County Hospital District DBA University Health System
First posted: 2015-01-22
Enrollment: 518
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* A child is eligible for the POM trial for meeting the following criteria:

  * identified by parent or legal guardian as Hispanic
  * age 6-11
  * overweight or obese (BMI between the 85th and 99.9thth (\<99th) percentile for age and gender
  * one parent/guardian that the child resides with full-time must agree to participate in intervention and evaluation activities.

Exclusion Criteria:

* A child will be excluded if he/she has:

  * a mental, emotional, or physical handicap identified by parents or health care provider that may interfere with study participation
  * a diagnosis of cardiovascular, pulmonary, or digestive disease
  * parent without a cell phone
  * parent unable or not willing to receive text messages
  * child or parent planning to move from the local area within the time span of the study.

Primary outcomes:
measure: Change from baseline in weight (kg)
timeFrame: 6 months
measure: Change from baseline in waist circumference (cm)
timeFrame: 6 months
measure: Change from baseline in body mass index (BMI z score)
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in fasting insulin (µIu/mL)
timeFrame: 6 months
measure: Change from baseline in fasting glucose (mg/dL)
timeFrame: 6 months
measure: Change in cholesterol (lipid panel: fasting total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) from baseline (mg/dL)
timeFrame: 6 months
measure: Change from baseline in moderate-to-vigorous physical activity (minutes/week)
timeFrame: 6 months
measure: Change from baseline in consumption of sugar-sweetened beverages (servings/week)
timeFrame: 6 months
measure: Change from baseline in consumption of fruits and vegetables (servings/day)
timeFrame: 6 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center San Antonio
state: Texas
Study officials:
affiliation: UT Health San Antonio
name: Deborah M Parra-Medina, PhD
role: PRINCIPAL_INVESTIGATOR
References: