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

Study Overview
=================
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.

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

Conditions
-----------------
Pediatric Obesity

Intervention / Treatment
-----------------
* Behavioral: Enhanced CATCH Elementary School Program
* Behavioral: CATCH Early Childhood (CEC)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Enhanced CATCH Elementary School Program is a Coordinated School Health Program that includes the CATCH Coordination Guide.<br>* Other names: CATCH; Coordinated School Health Program;Behavioral: CATCH Early Childhood (CEC)<br>* Implementation of the CATCH Early Childhood coordinated nutrition and physical activity program for Early Care and Education (ECE) centers.<br>* Other names: CEC, CATCH EC;|
| No Intervention: Comparison<br>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 | Change in Body Mass Index z-score | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric obesity, Diet, Physical activity, Schools, Early care and education