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

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enhanced CATCH Elementary School Program
CATCH Early Childhood (CEC)
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pediatric Obesity focused on measuring Pediatric obesity, Diet, Physical activity, Schools, Early care and education

Eligibility Criteria

2 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Comparison

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in Population-level Child Obesity as Defined by BMI z-score
    Change in Body Mass Index z-score

    Secondary Outcome Measures

    Full Information

    First Posted
    November 6, 2020
    Last Updated
    November 6, 2020
    Sponsor
    The University of Texas Health Science Center, Houston
    Collaborators
    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04625998
    Brief Title
    Texas Childhood Obesity Research Demonstration (TX CORD) Project -Primary Prevention Study
    Acronym
    TXCORDPRIM
    Official Title
    Systems Approach to Obesity Prevention in Underserved Children in Texas - Primary Prevention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2012 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Texas Health Science Center, Houston
    Collaborators
    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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pediatric Obesity
    Keywords
    Pediatric obesity, Diet, Physical activity, Schools, Early care and education

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    4378 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Comparison
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Enhanced CATCH Elementary School Program
    Other Intervention Name(s)
    CATCH; Coordinated School Health Program
    Intervention Description
    Enhanced CATCH Elementary School Program is a Coordinated School Health Program that includes the CATCH Coordination Guide.
    Intervention Type
    Behavioral
    Intervention Name(s)
    CATCH Early Childhood (CEC)
    Other Intervention Name(s)
    CEC, CATCH EC
    Intervention Description
    Implementation of the CATCH Early Childhood coordinated nutrition and physical activity program for Early Care and Education (ECE) centers.
    Primary Outcome Measure Information:
    Title
    Change in Population-level Child Obesity as Defined by BMI z-score
    Description
    Change in Body Mass Index z-score
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Deanna M Hoelscher, PhD
    Organizational Affiliation
    The University of Texas Health Science Center, Houston
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Nancy F Butte, PhD
    Organizational Affiliation
    Baylor College of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25555188
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25587670
    Citation
    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.
    Results Reference
    background

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

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