Childhood Obesity
Conditions
Keywords
child obesity, primary prevention, primary care, weight management, child overweight, BMI
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).
Interventions
Physician screening of patients to identify patients who are overweight or obese.
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 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.
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 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.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in obesity as indicated by body mass index (BMI) expressed as %95th percentile | Baseline to 3 months | Body mass index (BMI), expressed as %95th BMI percentile |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Fat free mass in kg | Baseline to 3 months | Fat free mass (kg) is defined as total body weight minus weight of body fat |
| Change in Fat mass in kg and percent | Baseline to 3 months | Fat mass (kg and %) is the body weight of fat |
| Change in Systolic blood pressure | Baseline to 3 months | Systolic blood pressure (mmHg) |
| Change in Waist:height ratio | Baseline to 3 months | Waist:height (ratio), each measured in cm |
| Change in Fitness as indicated by heart rate (post exercise 1 minute) | Baseline to 3 months | Heart rate (post step test exercise 1 min) |
| Change in Quality of Life as assessed by the Child Quality of Life (QOL) scale | Baseline to 3 months | Child Quality of Life (QOL) scale |
| Change in Diastolic blood pressure | Baseline to 3 months | Diastolic blood pressure (mmHg) |