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Texas Childhood Obesity Research Demonstration (TX CORD) Project (TXCORDRCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02724943
Recruitment Status : Completed
First Posted : March 31, 2016
Last Update Posted : March 31, 2016
Sponsor:
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
Information provided by (Responsible Party):
Deanna Hoelscher, The University of Texas Health Science Center, Houston

Study Description
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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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: BMI screening Behavioral: Next Steps brief clinical intervention Behavioral: MEND/CATCH Behavioral: MEND/CATCH Transition Phase Behavioral: Next Steps Self-Paced Booklet Not Applicable

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 549 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Systems Approach to Obesity Prevention in Underserved Children in Texas (Randomized Controlled Trial)
Study Start Date : August 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: TX CORD Intervention
TX CORD Intervention. The intervention entailed: (1) BMI screening, (2) Next Steps brief counseling materials for the healthcare provider, (3) a 3-month intensive Mind Exercise Nutrition Do It! and Coordinated Approach To Child Health (MEND/CATCH) phase, which included the Mind Exercise Nutrition Do it! ( MEND) programs for preschool (ages 2-5) and school-aged (ages 6-12) children coupled with adapted CATCH activities, and (5) a 9-month transition MEND/CATCH Transition phase, which offered monthly reinforcement sessions for parents and children, and twice weekly Young Men's Christian Association (YMCA) sports for children. Community Health Workers (CHWs) serve as program liaisons and assist in delivering all intervention group sessions as well as tracking families. Electronic Health Record (EHR) changes supported the screening and Next Steps delivery.
 Behavioral: BMI screening
Physician screening of patients to identify patients who are overweight or obese.
Other Name: Body Mass Index (BMI) Screening

Behavioral: Next 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).
Other Name: Next Steps

Behavioral: MEND/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.
Other Names:
  • Mind Exercise Nutrition Do it! (MEND)
  • Coordinated Approach To Child Health (CATCH)

Behavioral: MEND/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.
Active Comparator: Brief Clinic Comparison
Next Steps brief clinical intervention. The comparison program was a 12-month clinic-based program conducted at twelve partner healthcare clinics and entailed (1) EHR changes to support childhood obesity clinical visits; (2) BMI screening, (3) Next Steps brief counseling materials for the healthcare provider, and (4) Next Steps self-paced 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.
 Behavioral: BMI screening
Physician screening of patients to identify patients who are overweight or obese.
Other Name: Body Mass Index (BMI) Screening

Behavioral: Next 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).
Other Name: Next Steps

Behavioral: Next 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.
Other Name: Next Steps Workbook


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Layout table for eligibility information
Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724943


Sponsors and Collaborators
The University of Texas Health Science Center, Houston
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
Investigators
Layout table for investigator information
Principal Investigator: Deanna M Hoelscher, PhD The University of Texas Health Science Center, Houston
Principal Investigator: Nancy F Butte, PhD Children's Nutrition Research Center, Baylor College of Medicine
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Deanna Hoelscher, John P McGovern Professor in Health Promotion and Director, Michael & Susan Dell Center for Healthy Living, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02724943    
Other Study ID Numbers: HSC-SPH-11-0513 RCT
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Deanna Hoelscher, The University of Texas Health Science Center, Houston:
child obesity
primary prevention
primary care
 weight management
child overweight
BMI
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Pediatric Obesity
Overnutrition
 Nutrition Disorders
Overweight
Body Weight