Integrated Child Obesity Treatment Study: Bull City Healthy and Fit

NCT02573142 | Completed

• 1 other identifier: Pro00066366
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

obesity; treatment; community; integrated

Outcome Measures

Primary Outcomes (1)

• Change in Body Mass Index

  Body mass index will be measured at 3- and 6-months post-enrollment.

  3 and 6 months

Secondary Outcomes (3)

• Change in Health habits

  3- and 6-month

• Change in Cardiovascular fitness

  3- and 6-months

• Change in Adherence to clinic appointments

  3- and 6- months

Study Arms (2)

Education-only

ACTIVE COMPARATOR

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

Bull City Fit Intervention

EXPERIMENTAL

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

Interventions

Bull City Healthy and Fit BEHAVIORAL

Integrated model of child obesity treatment including clinical care plus community-based program for family-based experiential learning of healthy habits.

Bull City Fit Intervention

Healthy Lifestyles Clinic BEHAVIORAL

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

Education-only

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Duke Children's Health Center

Durham, North Carolina, 27704, United States

Location

Related Publications (1)

• Hoffman J, Frerichs L, Story M, Jones J, Gaskin K, Apple A, Skinner A, Armstrong S. An Integrated Clinic-Community Partnership for Child Obesity Treatment: A Randomized Pilot Trial. Pediatrics. 2018 Jan;141(1):e20171444. doi: 10.1542/peds.2017-1444. Epub 2017 Dec 13.

  PMID: 29237800 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah C Armstrong, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 9, 2015
• Study Start: October 1, 2015
• Primary Completion: March 13, 2017
• Study Completion: March 13, 2017
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

US (1)