NCT04625998

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,378

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

2.3 years

First QC Date

November 6, 2020

Last Update Submit

November 6, 2020

Conditions

Pediatric Obesity

Keywords

Pediatric obesityDietPhysical activitySchoolsEarly care and education

Outcome Measures

Primary Outcomes (1)

  • Change in Population-level Child Obesity as Defined by BMI z-score

    Change in Body Mass Index z-score

    2 years

Study Arms (2)

Intervention

EXPERIMENTAL

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 ProgramBehavioral: CATCH Early Childhood (CEC)

Comparison

NO INTERVENTION

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.

Interventions

Enhanced CATCH Elementary School ProgramBEHAVIORAL

Enhanced CATCH Elementary School Program is a Coordinated School Health Program that includes the CATCH Coordination Guide.

Also known as: CATCH; Coordinated School Health Program
Intervention
CATCH Early Childhood (CEC)BEHAVIORAL

Implementation of the CATCH Early Childhood coordinated nutrition and physical activity program for Early Care and Education (ECE) centers.

Also known as: CEC, CATCH EC
Intervention

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children attending selected elementary schools or Head Start Centers in the catchment areas.
  • Ages 2 to 12

You may not qualify if:

  • Children who are special needs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 25555188BACKGROUND

  • 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.

    PMID: 25587670BACKGROUND

MeSH Terms

Conditions

Pediatric ObesityMotor Activity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Deanna M Hoelscher, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

  • Nancy F Butte, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
John P. McGovern Professor in Health Promotion & Director, Michael & Susan Dell Center for Healthy Living, UTSPH

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 12, 2020

Study Start

February 1, 2012

Primary Completion

June 1, 2014

Study Completion

January 1, 2015

Last Updated

November 12, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share