Texas Childhood Obesity Research Demonstration (TX CORD) Project

NCT02724943 | Completed DMC

• 1 other identifier: HSC-SPH-11-0513 RCT
• Study Type: interventional
• Target: 549
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Childhood Obesity

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

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

  Baseline to 3 months

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

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

  3 months to 12 months

Other Outcomes (14)

• Change in Waist:height ratio

  Baseline to 3 months

• Change in Waist:height ratio

  3 months to 12 months

• Change in Fat free mass in kg

  Baseline to 3 months

Study Arms (2)

TX CORD Intervention

EXPERIMENTAL

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; Behavioral: Next Steps brief clinical intervention; Behavioral: MEND/CATCH; Behavioral: MEND/CATCH Transition Phase

Brief Clinic Comparison

ACTIVE COMPARATOR

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; Behavioral: Next Steps brief clinical intervention; Behavioral: Next Steps Self-Paced Booklet

Interventions

BMI screening BEHAVIORAL

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

Also known as: Body Mass Index (BMI) Screening

Brief Clinic Comparison; TX CORD Intervention

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).

Also known as: Next Steps

Brief Clinic Comparison; TX CORD Intervention

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.

Also known as: Mind Exercise Nutrition Do it! (MEND), Coordinated Approach To Child Health (CATCH)

TX CORD Intervention

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.

TX CORD 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.

Also known as: Next Steps Workbook

Brief Clinic Comparison

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years of age and
• ≥ 85th percentile for BMI

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Centers for Disease Control and Prevention: collaborator
• Baylor College of Medicine: collaborator
• Seton Healthcare Family: collaborator
• Texas Department of State Health Services: collaborator
• Duke University: collaborator
• City University of New York, School of Public Health: collaborator

Related Publications (5)

• 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: 25555188 BACKGROUND

• 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: 25587670 BACKGROUND

• 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.

  PMID: 32935936 DERIVED

• 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.

  PMID: 31944617 DERIVED

• 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.

  PMID: 28703504 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Body Mass Index; Mass Screening

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena; Biometry; Epidemiologic Measurements; Public Health; Environment and Public Health; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health Practice

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 31, 2016
• Study Start: August 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: March 31, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share