Integrated Child Obesity Treatment Study: Bull City Healthy and Fit (BCHF)
|ClinicalTrials.gov Identifier: NCT02573142|
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : April 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Childhood Obesity||Behavioral: Bull City Healthy and Fit Behavioral: Healthy Lifestyles Clinic||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Novel Healthcare-Community Partnership for Childhood Obesity Treatment: A Randomized Pilot Study|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||March 13, 2017|
|Actual Study Completion Date :||March 13, 2017|
Active Comparator: Education-only
Subjects in the education-only control will receive standard of care clinical treatment in the Duke Healthy Lifestyles clinic and educational materials describing community-based resources for physical activity and how to access them.
Behavioral: Healthy Lifestyles Clinic
Clinic-only model of care including clinical care and educational materials
Experimental: Bull City Fit Intervention
Subjects in the Bull City Fit intervention will receive standard of care clinical treatment in the Duke Healthy Lifestyles clinic and unlimited access to a community-based wellness program that includes physical fitness activities and cooking classes.
Behavioral: Bull City Healthy and Fit
Integrated model of child obesity treatment including clinical care plus community-based program for family-based experiential learning of healthy habits.
- Change in Body Mass Index [ Time Frame: 3 and 6 months ]Body mass index will be measured at 3- and 6-months post-enrollment.
- Change in Health habits [ Time Frame: 3- and 6-month ]Self-reported fruit and vegetable consumption, and sugary drink consumption at 3 and 6 months post-intervention
- Change in Cardiovascular fitness [ Time Frame: 3- and 6-months ]Score on 3-minute step test at 3- and 6-months post-enrollment
- Change in Adherence to clinic appointments [ Time Frame: 3- and 6- months ]Number of clinic appointments patient attended at 3- and 6-months post enrollment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573142
|United States, North Carolina|
|Duke Children's Health Center|
|Durham, North Carolina, United States, 27704|
|Principal Investigator:||Sarah C Armstrong, MD||Duke University|