Health4Kids Intervention Trial for Hispanic Families

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.

Conditions

• Pediatric Obesity

Interventions

BEHAVIORAL

behavioral counseling

Pediatrician trained in motivational interviewing techniques provides brief lifestyle behavioral counseling to child and parent using a Healthy Lifestyle Prescription

OTHER

Education Materials

Health education materials about healthy eating and physical activity and a community resource guide

BEHAVIORAL

Face to face counseling session

30 minute face-to-face family-centered behavioral counseling session delivered by a health educator

BEHAVIORAL

Text messages

regularly scheduled cell phone text messages for 12 months

BEHAVIORAL

Telephone Counseling

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

BEHAVIORAL

Newsletters

12 monthly newsletters mailed to participant homes

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• The University of Texas at San Antonio

  collaborator OTHER

• Bexar County Hospital District DBA University Health System

  collaborator OTHER

• The University of Texas Health Science Center at San Antonio

  lead OTHER

Principal Investigators

• Deborah M Parra-Medina, PhD · UT Health San Antonio

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

11 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2019-11-19

Completion

2020-03-31

Countries

• United States

Study Locations