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

November 6, 2020 updated by: Deanna Hoelscher, The University of Texas Health Science Center, Houston

Systems Approach to Obesity Prevention in Underserved Children in Texas - Primary Prevention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4378

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Population-level Child Obesity as Defined by BMI z-score
Time Frame: 2 years
Change in Body Mass Index z-score
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

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

Investigators

  • Principal Investigator: Nancy F Butte, PhD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

November 6, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (ACTUAL)

November 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-SPH-11-0513 (Primary)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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