Texas Childhood Obesity Research Demonstration (TX CORD) Project (TXCORDRCT)

The University of Texas System (UT)

Status: Completed

Conditions: Childhood Obesity

Treatments: Behavioral: Next Steps brief clinical intervention; Behavioral: MEND/CATCH Transition Phase; Behavioral: BMI screening; Behavioral: Next Steps Self-Paced Booklet; Behavioral: MEND/CATCH

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02724943

HSC-SPH-11-0513 RCT

Details and patient eligibility

About

A systems approach emphasizes the linkage between individual behavior change strategies and social and physical environmental changes, which act synergistically to facilitate (or inhibit) healthy eating and active living. The hypothesis of this study is that among low-income, ethnically diverse overweight and obese children, aged 2-12 years, a systems approach to child obesity will reduce body mass index (BMI) compared to primary prevention alone.

Full description

The goal of this project is to develop, implement and evaluate an integrated, systems-oriented obesity model for underserved, ethnically diverse children aged 2-12 years. The first step will include conducting an assets-based community assessment in low-income neighborhood catchment areas in Austin and Houston, TX with input and data-sharing from existing partnerships. Results from this assessment will inform and facilitate the implementation of both primary and secondary prevention efforts across multiple sectors (healthcare, school, and childcare). The demonstration project will include secondary prevention programs embedded within community primary prevention efforts. For primary prevention, a quasi-experimental approach will be used, where existing obesity prevention efforts are reinforced and optimized in healthcare clinics, Head Start Centers and schools in the catchment areas (NOTE: the primary prevention intervention study is further described in ClinicalTrials.gov at Texas Childhood Obesity Research Demonstration project Primary Prevention Intervention {TXCORDPRIM) under a different protocol & record). Secondary prevention includes integration of the investigative team's evidence-based portfolio of family and community interventions, specifically the MEND/CATCH programs. For secondary prevention, a randomized controlled trial design will be used in which individual overweight/obese children are randomized to a 12-month community-centered, family-based obesity program or to primary prevention alone.

The hypothesis of this study is that among low-income, ethnically diverse overweight and obese children, aged 2-12 years, a systems approach to child obesity will reduce body mass index (BMI, expressed as %95th percentile) compared to primary prevention alone. The specific aims of the grant are as follows (see below).

Aim 1: To implement and evaluate the efficacy of a systems approach to child obesity on reducing BMI (expressed as %95th percentile) by embedding a 12-month family-based secondary prevention program within a community primary prevention program. The secondary prevention weight management program will target overweight/obese children and their families in the primary prevention catchment areas in Austin and Houston. Overweight/obese children (total n=576), aged 2-12 years, will be randomly assigned to either the 12-month secondary prevention program (experimental) or the community primary prevention program alone (control), in equal age subgroups (2-5, 6-8, and 9-12 years). Analyses will be conducted by age group, and outcomes will include BMI as expressed as %95th percentile), obesity-related behaviors, quality of life, and program use indicators.

Aim 2: To quantify the incremental cost-effectiveness of the 12-month family-based secondary prevention program relative to primary prevention alone for child obesity. Activity Based Costing methods will be used to quantify the incremental cost of delivering the secondary prevention program relative to optimized healthcare. These costs will then be combined with the effectiveness data to quantify the incremental cost-effectiveness of the community-based intervention.

All project activities will be coordinated with input from Demonstration Project Research Network Committee (CDC and the Evaluation Center).

Enrollment: 549 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 2-12 years of age and
• ≥ 85th percentile for BMI

Exclusion criteria

• complications of obesity that would interfere with participation (e.g., severe respiratory insufficiency or orthopedic problems);
• underlying obesity-related conditions, such as systemic steroid use or endocrine abnormalities;
• severe psychological problems; and
• participation in an obesity treatment program within the past year.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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549 participants in 2 patient groups

TX CORD Intervention

Experimental group

Description:

TX CORD Intervention. The intervention entailed: (1) BMI screening, (2) Next Steps brief counseling materials for the healthcare provider, (3) a 3-month intensive Mind Exercise Nutrition Do It! and Coordinated Approach To Child Health (MEND/CATCH) phase, which included the Mind Exercise Nutrition Do it! ( MEND) programs for preschool (ages 2-5) and school-aged (ages 6-12) children coupled with adapted CATCH activities, and (5) a 9-month transition MEND/CATCH Transition phase, which offered monthly reinforcement sessions for parents and children, and twice weekly Young Men's Christian Association (YMCA) sports for children. Community Health Workers (CHWs) serve as program liaisons and assist in delivering all intervention group sessions as well as tracking families. Electronic Health Record (EHR) changes supported the screening and Next Steps delivery.

Treatment:

Behavioral: MEND/CATCH Transition Phase

Behavioral: MEND/CATCH

Behavioral: BMI screening

Behavioral: Next Steps brief clinical intervention

Brief Clinic Comparison

Active Comparator group

Description:

Next Steps brief clinical intervention. The comparison program was a 12-month clinic-based program conducted at twelve partner healthcare clinics and entailed (1) EHR changes to support childhood obesity clinical visits; (2) BMI screening, (3) Next Steps brief counseling materials for the healthcare provider, and (4) Next Steps self-paced booklet for parents and children to work on nutrition and physical activity targets in a self-directed manner. Families were encouraged to seek repeated clinical visits to address child obesity.

Treatment:

Behavioral: Next Steps Self-Paced Booklet

Behavioral: BMI screening

Behavioral: Next Steps brief clinical intervention