Integrated Child Obesity Treatment Study: Bull City Healthy and Fit
Completed · Not applicable
Conditions studied: Childhood Obesity
In brief
The primary aim of this study is to reduce body mass index (BMI) among children ages 5-11 who are obese by integrating behavioral treatment strategies in both clinic (Healthy Lifestyles) and community (Bull City Fit) settings. A two-group randomized, controlled, non-blinded pilot design will be utilized. The intended target population is the adult caregiver and a child with obesity (BMI ≥ 95th percentile) aged 5-11. The intervention condition will be standard care with Healthy Lifestyles programming plus Bull City Fit; upcoming activities will be texted to the parents mobile device using GoogleVoice. The control condition will be standard clinical care with Healthy Lifestyles programming. Primary outcome is BMI at 6 months. Secondary outcomes include anthropometric, psychosocial, and reported health behaviors.
Key facts
- Study ID
- NCT02573142
- Run by
- Duke University
- People needed
- 97
- Starts
- 2015-10-01
- Expected to finish
- 2017-03-13
- Last updated by the study team
- 2017-04-10
Who can join
Age: 5 and older, up to 11. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult aged 18 or older and is the child's primary caregiver ("parent")
- Child aged 5-11 years
- Child with age- and gender-specific BMI ≥ 95th percentile
You may not qualify if…
- Inability to read and write in English
- Family currently has paid membership to a gym or fitness center
- Parent with severe medical or mental health condition limiting ability to attend appointments
- Child with severe medical or mental health condition limiting ability to attend appointments or participate in behavioral therapies
- Parent and child live greater than 30 miles from the Duke Healthy Lifestyles clinic
- Plan to move out of state in next 6 months
- Child with medical condition as cause of obesity (e.g., hypothyroidism, Cushing's Syndrome, Prader-Willi syndrome (PWS), drug-induced obesity)
Where it is running
- Duke Children's Health Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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