Study 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.
Eligible Conditions
- Childhood Obesity
- Implementation
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 8 Secondary · Reporting Duration: Baseline, 6 months, 12 months
12 months
Patient Satisfaction at 12 months
6 months
Patient Satisfaction at 6 months
Month 12
Change in number of combined minutes per day of moderate and vigorous physical activity, as measured by Garmin vivofit4 fitness tracker
Month 12
Change in blood pressure
Change in diet quality
Change in mental health
Month 12
Change in percent of the 95th percentile for BMI Collected from clinic records.
Change in quality of life
Change in self-report physical activity
Month 30
Cost effects
Fidelity
Implementation characteristics
Up through 12 months
Assessment of harms related to the program
Month 18
Proportion of eligible children referred to the intervention
Up to 12 months
Healthcare utilization
Proportion of children with 26 hours or more of intervention contact
Unintended Consequences as measured by adverse events
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Control
1 of 2
Fit Together
1 of 2
Active Control
Experimental Treatment
400 Total Participants · 2 Treatment Groups
Primary Treatment: Fit Together · No Placebo Group · N/A
Fit Together
Behavioral
Experimental Group · 1 Intervention: Fit Together · Intervention Types: BehavioralControl
Behavioral
ActiveComparator Group · 1 Intervention: Educational materials · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 6 months, 12 months
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,173 Previous Clinical Trials
3,199,527 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,821 Previous Clinical Trials
2,237,736 Total Patients Enrolled
Eligibility Criteria
Age 6 - 11 · All Participants · 4 Total Inclusion Criteria
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Conditions
Cancer Related
Treatments