Integrated Child Obesity Treatment Study: Bull City Healthy and Fit (BCHF)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|