Health care system (HCS)-based interventions have been limited by their inattention to social and environmental barriers that impede improvement in obesity-related behaviors. Additionally, current pediatric obesity care delivery relies on an outdated provider:patient paradigm which is ill-suited for a problem as prevalent as obesity. HCSs often lack the organizational structure to provide longitudinal care for children with chronic illnesses, the clinicians to manage and support patients with chronic illnesses outside of clinic, and/or the health information systems that support the use of evidence-based practices at the point-of-care. Thus, the research question this study is designed to address is whether a novel approach to care delivery that leverages delivery system and community resources and addresses socio-contextual factors will improve family-centered childhood obesity outcomes. The primary specific aims are to examine the extent to which the intervention, compared to the control condition, results in: 1. A smaller age-associated increase in BMI over a 12-month period. 2. Improved parental and child ratings of pediatric health-related quality of life. The secondary aims are: 1. To examine parental ratings of quality and family-centeredness of pediatric obesity care and compare outcomes among participants in the intervention with the control condition 2. To assess change in weight-related behaviors and compare outcomes among participants in the intervention with the control condition 3. To assess the following process measures: * Reach * Extent of implementation * Fidelity to protocol * Parent satisfaction 4. To examine the extent to which neighborhood environments modify observed intervention effects 5. To assess the documentation of Healthcare Effectiveness Data and Information Set (HEDIS) measures in participant medical records
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
721
Parent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. During these visits, the health coach will coach the parent/child duos on improving obesity-related behaviors . The health coach will also help the family identify supports to assist with behavior change; discuss family health habits and the home environment; and review and encourage use of materials related to both specific target behaviors and available resources in the community. Following the first call with the health coach, parents will receive semi-weekly text messages designed by the study team. The messages will alternate in structure between 2 types of messages; 1) skills training messages will deliver tips and motivational messages to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond to the message and track health behaviors important to this study.
Harvard Vanguard Medical Associates
Boston, Massachusetts, United States
Change in BMI z Score
Height and weight will be measured by the medical assistants at each site using standard protocols. BMI measures will be obtained from the electronic health record (EHR) as provided through usual care. BMI measures will be converted to z-scores using CDC age and sex-specific normative data for children between 2 and 20 years old. This will allow the research team to combine data across children of different ages.
Time frame: baseline and one year
Change in Quality of Life
The PedsQL is an extensively validated, widely used, 23-item measure of health-related quality of life in children with chronic conditions such as obesity. Parents will be asked to complete 4 subscales: physical health, school, social, and emotional functioning which exists for parental report of children as young as 2 years of age. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better HRQOL. Scale Scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the Scale Score is not computed.
Time frame: baseline and one year
Change in Parent Resource Empowerment
The five items in the scale assessed parents' perceived knowledge of resources, ability to access resources, comfort with accessing resources, knowledge of how to find resources, and ability to acquire resources related to child weight management. For each question, parents responded strongly disagree, disagree, agree, or strongly agree, which were worth 1 to 4 points, respectively. Items were averaged to create a summary parental resource empowerment score (range= 1-4), where a higher score indicated greater perceived knowledge and ability to access resources related to weight management. Cronbach's α for this score was 0.87.
Time frame: Baseline to one-year follow-up
Change in Screen Time
Average hours/day spent watching television, videos, or playing games displayed on media such as television, desktop computers, laptops, portable DVD players, iPads or smartphones.
Time frame: baseline and one year
Change in Sleep
Average hours/day spent sleeping
Time frame: baseline and 1 year
Change in Physical Activity
In the past week, how many days the child was physically active for a total of at least 60 minutes per day.
Time frame: baseline and 1 year
Change in Fruit and Vegetable Consumption
Number of times the child consumed of vegetables and fruits yesterday
Time frame: baseline and 1 year
Change in Consumption of Sugar-sweetened Beverages and Juice
Number of time child consumed juice (e.g., orange juice, apple juice, or grape juice), fruit-flavored drinks (e.g., Kool-Aid, sports drinks, Goya juice, etc.), regular soda, soft drinks, or Malta yesterday.
Time frame: baseline and 1 year
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