Clinical trial NCT02724943: Texas Childhood Obesity Research Demonstration (TX CORD) Project
Official title: Systems Approach to Obesity Prevention in Underserved Children in Texas (Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: child obesity
primary prevention
primary care
weight management
child overweight
BMI
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Baylor College of Medicine
name: Seton Healthcare Family
name: Texas Department of State Health Services
name: Duke University
name: City University of New York, School of Public Health
First posted: 2016-03-31
Enrollment: 549
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility 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.

Primary outcomes:
measure: Change in obesity as indicated by body mass index (BMI) expressed as %95th percentile
timeFrame: Baseline to 3 months
measure: Change in obesity as indicated by body mass index (BMI) expressed as %95th percentile
timeFrame: 3 months to 12 months
Secondary outcomes:
Other outcomes:
measure: Change in Waist:height ratio
timeFrame: Baseline to 3 months
measure: Change in Waist:height ratio
timeFrame: 3 months to 12 months
measure: Change in Fat free mass in kg
timeFrame: Baseline to 3 months
measure: Change in Fat free mass in kg
timeFrame: 3 months to 12 months
measure: Change in Fat mass in kg and percent
timeFrame: Baseline to 3 months
measure: Change in Fat mass in kg and percent
timeFrame: 3 months to 12 months
measure: Change in Systolic blood pressure
timeFrame: Baseline to 3 months
measure: Change in Systolic blood pressure
timeFrame: 3 months to 12 months
measure: Change in Diastolic blood pressure
timeFrame: Baseline to 3 months
measure: Change in Diastolic blood pressure
timeFrame: 3 months to 12 months
measure: Change in Fitness as indicated by heart rate (post exercise 1 minute)
timeFrame: Baseline to 3 months
measure: Change in Fitness as indicated by heart rate (post exercise 1 minute)
timeFrame: 3 months to 12 months
measure: Change in Quality of Life as assessed by the Child Quality of Life (QOL) scale
timeFrame: Baseline to 3 months
measure: Change in Quality of Life as assessed by the Child Quality of Life (QOL) scale
timeFrame: 3 months to 12 months
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Deanna M Hoelscher, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Nutrition Research Center, Baylor College of Medicine
name: Nancy F Butte, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.