Implementation, Pediatric Obesity
Conditions
Keywords
Physical Activity, Pediatrics
Brief summary
The proposed project will test an implementation strategy (the "TrailGuide") for delivering an existing model of pediatric obesity treatment ("Fit Together") that has demonstrated ability to meet published recommendations for improving health outcomes of children with obesity.
Detailed description
Evidence-based treatment for childhood obesity exists, yet a fundamental knowledge-to-action gap has significantly limited the uptake of recommendations into clinical practice, particularly in low-income settings. Persistence of this gap represents a large-scale public health threat, as the earliest generation of children living through the obesity epidemic now enters adulthood, they are the first in US history to have a shorter life expectancy than their parents, mainly due to rising rates of obesity-related cancers and cardiovascular disease. A central challenge in delivering recommended treatment is the intensity; ≥26 hours of face-to-face contact are necessary to achieve health benefits and risk reduction. The objective of the proposed project is to develop and test an implementation strategy that pairs primary care pediatric clinics with the municipal Parks and Recreation (P&R) centers to deliver the current treatment recommendations with high fidelity, while allowing while allowing crucial adaptations for the local and cultural context. Using the Fit Together model, the clinical partner provides standard medical treatment for pediatric obesity, while the community partner (typically parks and recreation) provides space facilitating the activity/nutrition sessions specifically for children referred from the clinic, along with their families. Fit Together will be implemented in two new communities in North Carolina, and investigators will study implementation outcomes as well as 12-month patient outcomes. A local cohort has been added in Durham, North Carolina, where their local Fit Together model has re-started their community activity program, and investigators will look at 6-month patient outcomes.
Interventions
BEHAVIORALFit Together
Fit Together intervention follows a clinic and community partnership model for childhood obesity treatment. Children with obesity will receive standard of care obesity treatment from their usual provider and will also receive a referral to an activity program run out of the local community center. Each session delivers a combination of high-intensity individual exercises, sports and games, and unstructured playtime to help children reach the US Physical Activity guidelines of 60min moderate-to-vigorous physical activity daily. There will also be a nutrition activity session offered regularly.
BEHAVIORALEducational materials
Participants will receive a child-friendly cooking magazine mailed quarterly and a local Parks and Recreation program guide.
Sponsors
Duke University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
Winston-Salem \& Charlotte Cohorts: Inclusion Criteria: * Child receives primary care at one of the participating clinics * Child age 5-12 years old at the time of enrollment in the study * BMI greater than or equal to 95th percentile for age and sex (or greater than or equal to 85th%ile at the discretion of the provider) * English- or Spanish-speaking
Exclusion criteria
* Injuries or disabilities preventing physical activity. Inclusion criteria for caregivers: * Age 18 or older * English or Spanish-speaking * Caregiver has smartphone and is willing to download app(s) used in the study * Anticipates bringing the child to the program the majority of the time and spends significant time with the child outside of program hours (necessary in order to accurately answer survey questions about child behavior and child participation in the program, and provide feedback about the program) * Does not have plans to move out of the area during the duration of the study (12 months) Durham Cohort: Inclusion Criteria: * Child is a Healthy Lifestyles patient and has been referred to Bull City Fit * Child is 5-12 years old at the time of enrollment in the study Child BMI is greater than or equal to the 95th %ile (An exception may be made if BMI is now below the 95th%ile, but was \> 95th%ile at the time they started attending Healthy Lifestyles/Bull City Fit. An exception may also be made if BMI was below the 95th%ile but \> 85th%ile and obesity treatment/program participation is clinically indicated (e.g., provider still referred them to Healthy Lifestyles and their HL provider referred them to BCF)) * Child and parent are English- or Spanish-speaking * Child does not have an injury or disability preventing them for engaging in physical activity -- if a child meets this
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in percent of the 95th percentile for BMI Collected from clinic records. | Baseline, 3 months, 6 months, and 12 months | Change in child's BMI, based on percent of the 95th percentile, measured using height and weight collected from clinic/medical records |
| Proportion of children with 26 hours or more of intervention contact | Up to 12 months | Measured by program attendance |
| Change in number of combined minutes per day of moderate and vigorous physical activity, as measured by Garmin vivofit4 fitness tracker | Baseline up to 12 months | Change in physical activity measured by Garmin vivofit4 fitness tracker |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-report physical activity | Baseline, 6 months, and 12 months | Measured by the Evaluation of Activity Surveys in Youth (EASY); Scoring: range 0-88, higher scores indicate more activity |
| Change in quality of life | Baseline, 6 months, and 12 months | Measured by Sizing Them Up; Scoring: range 0-100, higher scores indicate better health-related quality of life |
| Unintended Consequences as measured by adverse events | Up to 12 months | Measured by collecting adverse events throughout participation |
| Patient Satisfaction at 3 months | 3 months | Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction |
| Patient Satisfaction at 6 months | 6 months | Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction |
| Patient Satisfaction at 12 months | 12 months | Measured by satisfaction survey; Scoring: ranging 5-25, higher scores indicate higher satisfaction |
| Change in diet quality | Baseline, 6 months, 12 months | Measured by the Dietary Screener Questionnaire (DSQ) |
| Physical activity during program sessions measured by accelerometer | 6 months | Measured by the average number of minutes of moderate to vigorous physical activity (MVPA) per session. |
Countries
United States
Outcome results
None listed