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Completed

NCT Number: NCT02724943

Texas Childhood Obesity Research Demonstration (TX CORD) Project

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMI screening

Behavioral

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

Other names: Body Mass Index (BMI) Screening

Next Steps brief clinical intervention

Behavioral

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).

Other names: Next Steps

MEND/CATCH

Behavioral

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.

Other names: Mind Exercise Nutrition Do it! (MEND), Coordinated Approach To Child Health (CATCH)

MEND/CATCH Transition Phase

Behavioral

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.

Next Steps Self-Paced Booklet

Behavioral

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.

Other names: Next Steps Workbook

Primary outcomes

  1. Change in obesity as indicated by body mass index (BMI) expressed as %95th percentile

    Time frame: Baseline to 3 months

    Body mass index (BMI), expressed as %95th BMI percentile

  2. Change in obesity as indicated by body mass index (BMI) expressed as %95th percentile

    Time frame: 3 months to 12 months

    Body mass index (BMI), expressed as %95th BMI percentile

Other outcomes

  1. Change in Waist:height ratio

    Time frame: Baseline to 3 months

    Waist:height (ratio), each measured in cm

  2. Change in Waist:height ratio

    Time frame: 3 months to 12 months

    Waist:height (ratio), each measured in cm

  3. Change in Fat free mass in kg

    Time frame: Baseline to 3 months

    Fat free mass (kg) is defined as total body weight minus weight of body fat

  4. Change in Fat free mass in kg

    Time frame: 3 months to 12 months

    Fat free mass (kg) is defined as total body weight minus weight of body fat

  5. Change in Fat mass in kg and percent

    Time frame: Baseline to 3 months

    Fat mass (kg and %) is the body weight of fat

  6. Change in Fat mass in kg and percent

    Time frame: 3 months to 12 months

    Fat mass (kg and %) is the body weight of fat

  7. Change in Systolic blood pressure

    Time frame: Baseline to 3 months

    Systolic blood pressure (mmHg)

  8. Change in Systolic blood pressure

    Time frame: 3 months to 12 months

    Systolic blood pressure (mmHg)

  9. Change in Diastolic blood pressure

    Time frame: Baseline to 3 months

    Diastolic blood pressure (mmHg)

  10. Change in Diastolic blood pressure

    Time frame: 3 months to 12 months

    Diastolic blood pressure (mmHg)

  11. Change in Fitness as indicated by heart rate (post exercise 1 minute)

    Time frame: Baseline to 3 months

    Heart rate (post step test exercise 1 min)

  12. Change in Fitness as indicated by heart rate (post exercise 1 minute)

    Time frame: 3 months to 12 months

    Heart rate (post step test exercise 1 min)

  13. Change in Quality of Life as assessed by the Child Quality of Life (QOL) scale

    Time frame: Baseline to 3 months

    Child Quality of Life (QOL) scale

  14. Change in Quality of Life as assessed by the Child Quality of Life (QOL) scale

    Time frame: 3 months to 12 months

    Child Quality of Life (QOL) scale

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

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

Registry information

Official study title

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

Acronym: TXCORDRCT

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Mar 31, 2016
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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