Health4Kids Intervention Trial for Hispanic Families

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.

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.