Childhood Obesity Clinical Trial
— BCHFOfficial title:
A Novel Healthcare-Community Partnership for Childhood Obesity Treatment: A Randomized Pilot Study
Verified date | April 2017 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 97 |
Est. completion date | March 13, 2017 |
Est. primary completion date | March 13, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 11 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
United States | Duke Children's Health Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | University of North Carolina, Chapel Hill |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Body Mass Index | Body mass index will be measured at 3- and 6-months post-enrollment. | 3 and 6 months | |
Secondary | Change in Health habits | Self-reported fruit and vegetable consumption, and sugary drink consumption at 3 and 6 months post-intervention | 3- and 6-month | |
Secondary | Change in Cardiovascular fitness | Score on 3-minute step test at 3- and 6-months post-enrollment | 3- and 6-months | |
Secondary | Change in Adherence to clinic appointments | Number of clinic appointments patient attended at 3- and 6-months post enrollment | 3- and 6- months |
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