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Texas Childhood Obesity Research Demonstration (TX CORD) Project

Systems Approach to Obesity Prevention in Underserved Children in Texas (Randomized Controlled Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02724943
Acronym
TXCORDRCT
Enrollment
549
Registered
2016-03-31
Start date
2012-08-31
Completion date
2015-02-28
Last updated
2016-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity

Keywords

child obesity, primary prevention, primary care, weight management, child overweight, BMI

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. The hypothesis of this study is that among low-income, ethnically diverse overweight and obese children, aged 2-12 years, a systems approach to child obesity will reduce body mass index (BMI) compared to primary prevention alone.

Detailed description

The goal of this project is to develop, implement and evaluate an integrated, systems-oriented obesity model for underserved, ethnically diverse children aged 2-12 years. The first step will include conducting an assets-based community assessment in low-income neighborhood catchment areas in Austin and Houston, TX with input and data-sharing from existing partnerships. Results from this assessment will inform and facilitate the implementation of both primary and secondary prevention efforts across multiple sectors (healthcare, school, and childcare). The demonstration project will include secondary prevention programs embedded within community primary prevention efforts. For primary prevention, a quasi-experimental approach will be used, where existing obesity prevention efforts are reinforced and optimized in healthcare clinics, Head Start Centers and schools in the catchment areas (NOTE: the primary prevention intervention study is further described in ClinicalTrials.gov at Texas Childhood Obesity Research Demonstration project Primary Prevention Intervention {TXCORDPRIM) under a different protocol & record). Secondary prevention includes integration of the investigative team's evidence-based portfolio of family and community interventions, specifically the MEND/CATCH programs. For secondary prevention, a randomized controlled trial design will be used in which individual overweight/obese children are randomized to a 12-month community-centered, family-based obesity program or to primary prevention alone. The hypothesis of this study is that among low-income, ethnically diverse overweight and obese children, aged 2-12 years, a systems approach to child obesity will reduce body mass index (BMI, expressed as %95th percentile) compared to primary prevention alone. The specific aims of the grant are as follows (see below). Aim 1: To implement and evaluate the efficacy of a systems approach to child obesity on reducing BMI (expressed as %95th percentile) by embedding a 12-month family-based secondary prevention program within a community primary prevention program. The secondary prevention weight management program will target overweight/obese children and their families in the primary prevention catchment areas in Austin and Houston. Overweight/obese children (total n=576), aged 2-12 years, will be randomly assigned to either the 12-month secondary prevention program (experimental) or the community primary prevention program alone (control), in equal age subgroups (2-5, 6-8, and 9-12 years). Analyses will be conducted by age group, and outcomes will include BMI as expressed as %95th percentile), obesity-related behaviors, quality of life, and program use indicators. Aim 2: To quantify the incremental cost-effectiveness of the 12-month family-based secondary prevention program relative to primary prevention alone for child obesity. Activity Based Costing methods will be used to quantify the incremental cost of delivering the secondary prevention program relative to optimized healthcare. These costs will then be combined with the effectiveness data to quantify the incremental cost-effectiveness of the community-based intervention. All project activities will be coordinated with input from Demonstration Project Research Network Committee (CDC and the Evaluation Center).

Interventions

BEHAVIORALBMI screening

Physician screening of patients to identify patients who are overweight or obese.

BEHAVIORALNext Steps brief clinical intervention

This intervention included identification of children who were overweight or obese, and Next Steps brief counseling materials for the healthcare provider (prior to enrollment in the intervention).

BEHAVIORALMEND/CATCH

MEND 2-5 and MEND/CATCH 6-12 programs are multi-component interventions including behavioral, nutrition, and physical activity sessions. In the intensive (first 3 months) phase, MEND 2-5 entailed nine weekly sessions and MEND 6-12 entailed 18 twice weekly sessions.

BEHAVIORALMEND/CATCH Transition Phase

The transition phase (next 9 months of the 12-month program) included monthly 90-minute sessions for parents and children included MEND reviews, cooking classes, Being Well book, CATCH activities and MEND World activities. Children were enrolled in YMCA sports teams or programs offered twice weekly to encourage physical activity. Weekly text messages were sent to parents to reinforce behavioral objectives of the intervention.

BEHAVIORALNext Steps Self-Paced Booklet

Next Steps booklet for parents and children to work on nutrition and physical activity targets in a self-directed manner. Families were encouraged to seek repeated clinical visits to address child obesity as a follow up to the self-paced booklet.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* 2-12 years of age and * ≥ 85th percentile for BMI

Exclusion criteria

* complications of obesity that would interfere with participation (e.g., severe respiratory insufficiency or orthopedic problems); * underlying obesity-related conditions, such as systemic steroid use or endocrine abnormalities; * severe psychological problems; and * participation in an obesity treatment program within the past year.

Design outcomes

Primary

MeasureTime frameDescription
Change in obesity as indicated by body mass index (BMI) expressed as %95th percentileBaseline to 3 monthsBody mass index (BMI), expressed as %95th BMI percentile

Other

MeasureTime frameDescription
Change in Fat free mass in kgBaseline to 3 monthsFat free mass (kg) is defined as total body weight minus weight of body fat
Change in Fat mass in kg and percentBaseline to 3 monthsFat mass (kg and %) is the body weight of fat
Change in Systolic blood pressureBaseline to 3 monthsSystolic blood pressure (mmHg)
Change in Waist:height ratioBaseline to 3 monthsWaist:height (ratio), each measured in cm
Change in Fitness as indicated by heart rate (post exercise 1 minute)Baseline to 3 monthsHeart rate (post step test exercise 1 min)
Change in Quality of Life as assessed by the Child Quality of Life (QOL) scaleBaseline to 3 monthsChild Quality of Life (QOL) scale
Change in Diastolic blood pressureBaseline to 3 monthsDiastolic blood pressure (mmHg)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026