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Integrated Child Obesity Treatment Study: Bull City Healthy and Fit (BCHF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02573142
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : April 10, 2017
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: Bull City Healthy and Fit Behavioral: Healthy Lifestyles Clinic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in Body Mass Index [ Time Frame: 3 and 6 months ]
    Body mass index will be measured at 3- and 6-months post-enrollment.


Secondary Outcome Measures :
  1. 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

  2. Change in Cardiovascular fitness [ Time Frame: 3- and 6-months ]
    Score on 3-minute step test at 3- and 6-months post-enrollment

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Duke Children's Health Center
Durham, North Carolina, United States, 27704
Sponsors and Collaborators
Duke University
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Sarah C Armstrong, MD Duke University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02573142    
Other Study ID Numbers: Pro00066366
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Keywords provided by Duke University:
obesity
treatment
community
integrated
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms