Health4Kids Intervention Trial for Hispanic Families

Completed · Not applicable

Conditions studied: Pediatric Obesity

In brief

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.

Key facts

Study ID

NCT02343367

Run by

The University of Texas Health Science Center at San Antonio

People needed

518

Starts

2015-01-01

Expected to finish

2020-03-31

Last updated by the study team

2020-12-21

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas Health Science Center San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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