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Integrated Child Obesity Treatment Study: Bull City Healthy and Fit

NCT02573142 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2017-04-10

No results posted yet for this study

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.

Conditions

  • Childhood Obesity

Interventions

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.

BEHAVIORAL

Healthy Lifestyles Clinic

Clinic-only model of care including clinical care and educational materials

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Sarah C Armstrong, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-03-13
Completion
2017-03-13

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02573142 on ClinicalTrials.gov