TXCORDPRIM: Texas Childhood Obesity Research Demonstration (TX CORD) Project -Primary Prevention Study

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT04625998
• Collaborator: Centers for Disease Control and Prevention (U.S. Fed), Baylor College of Medicine (Other), Seton Healthcare Family (Other), Texas Department of State Health Services (Other), Duke University (Other), City University of New York, School of Public Health (Other)
• Enrollment: 4,378
• Arms: 2
• Duration (Months): 35

Study Details

Study Description

Brief Summary

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. We hypothesize that among low income, ethnically diverse overweight and obese children, aged 2-12 years, a systems approach to child obesity will reduce BMI compared to primary prevention alone.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Obesity	Behavioral: Enhanced CATCH Elementary School Program; Behavioral: CATCH Early Childhood (CEC)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 4378 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Systems Approach to Obesity Prevention in Underserved Children in Texas - Primary Prevention
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Elementary schools and Head Start centers in the intervention catchment areas implemented (1) an enhanced Coordinated Approach To Child Health (CATCH) program for elementary schools using the CATCH Coordination Guide (Enhanced CATCH Elementary School Program), and (2) CATCH Early Childhood program for Head Start Centers.	Behavioral: Enhanced CATCH Elementary School Program; Enhanced CATCH Elementary School Program is a Coordinated School Health Program that includes the CATCH Coordination Guide.; Other Names: CATCH; Coordinated School Health Program ; Behavioral: CATCH Early Childhood (CEC); Implementation of the CATCH Early Childhood coordinated nutrition and physical activity program for Early Care and Education (ECE) centers.; Other Names: CEC, CATCH EC
No Intervention: Comparison Elementary schools and Head Start centers in the comparison catchment area used their regular school and early care and education (ECE) nutrition and physical activity programs. Elementary schools were required by law to implement a coordinated school health program.

Outcome Measures

Primary Outcome Measures

1. Change in Population-level Child Obesity as Defined by BMI z-score [2 years]

   Change in Body Mass Index z-score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Children attending selected elementary schools or Head Start Centers in the catchment areas.

• Ages 2 to 12

Exclusion Criteria:

• Children who are special needs

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston
• Centers for Disease Control and Prevention
• Baylor College of Medicine
• Seton Healthcare Family
• Texas Department of State Health Services
• Duke University
• City University of New York, School of Public Health

Investigators

• Principal Investigator: Deanna M Hoelscher, PhD, The University of Texas Health Science Center, Houston
• Principal Investigator: Nancy F Butte, PhD, Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hoelscher DM, Butte NF, Barlow S, Vandewater EA, Sharma SV, Huang T, Finkelstein E, Pont S, Sacher P, Byrd-Williams C, Oluyomi AO, Durand C, Li L, Kelder SH. Incorporating primary and secondary prevention approaches to address childhood obesity prevention and treatment in a low-income, ethnically diverse population: study design and demographic data from the Texas Childhood Obesity Research Demonstration (TX CORD) study. Child Obes. 2015 Feb;11(1):71-91. doi: 10.1089/chi.2014.0084. Epub 2015 Jan 2.
• Oluyomi AO, Byars A, Byrd-Williams C, Sharma SV, Durand C, Hoelscher DM, Butte NF, Kelder SH. The utility of Geographical Information Systems (GIS) in systems-oriented obesity intervention projects: the selection of comparable study sites for a quasi-experimental intervention design--TX CORD. Child Obes. 2015 Feb;11(1):58-70. doi: 10.1089/chi.2014.0054. Epub 2015 Jan 14.

• Responsible Party: Deanna Hoelscher, John P. McGovern Professor in Health Promotion & Director, Michael & Susan Dell Center for Healthy Living, UTSPH, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT04625998
• Other Study ID Numbers: HSC-SPH-11-0513 (Primary)
• First Posted: Nov 12, 2020
• Last Update Posted: Nov 12, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Deanna Hoelscher, John P. McGovern Professor in Health Promotion & Director, Michael & Susan Dell Center for Healthy Living, UTSPH, The University of Texas Health Science Center, Houston: Pediatric obesity; Diet; Physical activity; Schools; Early care and education
• Additional relevant MeSH terms: Obesity; Pediatric Obesity

Study Results

No Results Posted as of Nov 12, 2020