Texas Childhood Obesity Research Demonstration (TX CORD) Project
NCT ID: NCT02724943
Last Updated: 2016-03-31
Study Results
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Basic Information
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COMPLETED
NA
549 participants
INTERVENTIONAL
2012-08-31
2015-02-28
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
BMI screening
Physician screening of patients to identify patients who are overweight or obese.
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).
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.
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.
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.
BMI screening
Physician screening of patients to identify patients who are overweight or obese.
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).
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.
Interventions
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BMI screening
Physician screening of patients to identify patients who are overweight or obese.
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).
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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥ 85th percentile for BMI
Exclusion Criteria
* 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.
2 Years
12 Years
ALL
Yes
Sponsors
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Centers for Disease Control and Prevention
FED
Baylor College of Medicine
OTHER
Seton Healthcare Family
OTHER
Texas Department of State Health Services
OTHER
Duke University
OTHER
City University of New York, School of Public Health
OTHER
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Deanna Hoelscher
John P McGovern Professor in Health Promotion and Director, Michael & Susan Dell Center for Healthy Living
Principal Investigators
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Deanna M Hoelscher, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Nancy F Butte, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Nutrition Research Center, Baylor College of Medicine
References
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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.
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.
Barlow SE, Salahuddin M, Durand C, Pont SJ, Hoelscher DM, Butte NF. Evaluation of BMI Metrics to Assess Change in Adiposity in Children with Overweight and Moderate and Severe Obesity. Obesity (Silver Spring). 2020 Aug;28(8):1512-1518. doi: 10.1002/oby.22858. Epub 2020 Jul 6.
Barlow SE, Durand C, Salahuddin M, Pont SJ, Butte NF, Hoelscher DM. Who benefits from the intervention? Correlates of successful BMI reduction in the Texas Childhood Obesity Demonstration Project (TX-CORD). Pediatr Obes. 2020 May;15(5):e12609. doi: 10.1111/ijpo.12609. Epub 2020 Jan 15.
Butte NF, Hoelscher DM, Barlow SE, Pont S, Durand C, Vandewater EA, Liu Y, Adolph AL, Perez A, Wilson TA, Gonzalez A, Puyau MR, Sharma SV, Byrd-Williams C, Oluyomi A, Huang T, Finkelstein EA, Sacher PM, Kelder SH. Efficacy of a Community- Versus Primary Care-Centered Program for Childhood Obesity: TX CORD RCT. Obesity (Silver Spring). 2017 Sep;25(9):1584-1593. doi: 10.1002/oby.21929. Epub 2017 Jul 13.
Other Identifiers
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HSC-SPH-11-0513 RCT
Identifier Type: -
Identifier Source: org_study_id