Integrated Child Obesity Treatment Study: Bull City Healthy and Fit
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

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.
    

Detailed description: 
      Prevention strategies have made important strides to stabilize obesity prevalence, however US
      childhood obesity prevalence remains high (17%) and effective treatment has been elusive.
      Furthermore, children with severe obesity continues to increase, especially among Hispanics
      and African Americans. These children have increased cardio-metabolic risks and
      comorbidities, and healthcare costs are concentrated among them. It is critical to identify
      effective interventions that can be made widely available for low-income, diverse populations
      in order to mitigate economic and societal costs.

      High-intensity behavioral treatment interventions in specialized clinical research settings
      have been shown to be modestly effective.Effects tend to be small, short-term, and difficult
      to replicate in "real-world" clinical settings. Community-based settings (e.g., recreation
      centers) offer an attractive setting to deliver treatment. Community centers are locally
      accessible, can offer activities during evenings and on weekends, and provide relaxed
      environments that support social interaction. However, community-based interventions cannot
      provide the patient-centered medical care and individual nutrition counseling currently
      recommended for obesity treatment. New recommendations encourage linking clinical treatment
      with community resources, yet evidence demonstrating the feasibility and efficacy of such
      interventions is limited.

      Locally, the investigators have developed both a specialized clinical obesity treatment
      program as well as a community based treatment program, and have linked the two via a shared
      use agreement. The innovative model provides multidisciplinary, individualized behavioral
      modification counseling and support through the clinic-based Healthy Lifestyles program, and
      higher intensity social and environmental support to reinforce behavior change through Bull
      City Fit programming.

      The clinical program, Duke Children's Healthy Lifestyles (HL), is a comprehensive (AAP Stage
      2-4) childhood obesity treatment program that has served primarily low-income African
      American and Hispanic families since 2006. In short, children aged 22 years and under with
      BMI ≥ 95th percentile (i.e., obese) are referred by their primary physician to the
      multidisciplinary Healthy Lifestyles clinic for treatment of obesity and related
      co-morbidities. The intervention involves monthly visits for one year to meet with medical,
      dietary, exercise and behavior specialists all certified in Motivational Interviewing.
      Similar to other interventions delivered through primary care settings, the Healthy
      Lifestyles model alone leads to measurable but not clinically significant decreases in body
      mass index.

      The community-based program, Bull City Fit (BCF), was developed in 2012 by HL staff to
      increase intensity of the clinical intervention. The community center is a Durham Parks and
      Recreation (PR) facility. The investigators chose this municipal partner due to potential
      scalability of the intervention; over 5,000 PR facilities exist nationwide and every American
      lives within a 20 mile radius of a PR facility (DPR.gov). Bull City Fit provides free access
      to Edison Johnson Community Center, including 2 hours of staffed programming six days a week
      designed specifically for Healthy Lifestyles patients aged 2-18 and their families. This
      includes sports, games, cooking classes, gardening, parent support groups, teen support
      groups, and developmentally appropriate activities for all ages. With guidance from Healthy
      Lifestyles clinic providers, Bull City Fit programming is run by trained volunteers who are
      primarily Duke University students, pediatric residents, and community members invested in
      the wellness of families in their city.

      New treatment models with potential for both scalability and effect are critically needed to
      defray the estimated $14.1 billion annual direct costs of childhood obesity (e.g.,
      prescription drugs, emergency and outpatient visits),5 which will only rise substantially as
      children with obesity become adults with obesity. The healthcare-community partnership model
      has been operational since 2012, primarily reaching a low-income and racially diverse
      population. The model has potential to scale via establishment of similar partnerships in
      other communities. The goal of the present study is to provide important new information
      about the effectiveness of the model, which can be used to refine and tailor the intervention
      for future expansion.

      Study interventions

      Trained clinical providers will collect and perform assessments that are in accordance with
      the current clinical protocol. A trained research assistant will collect all other measures
      either through chart review or direct questioning of the parent and/or child. Subjects will
      be randomized to the intervention or control group using a random number generator (Excel,
      2010). A sample of 10 subjects will receive an accelerometer for 1 week as described above.

      Subjects randomized to the standard care control group includes a lifestyle counseling visit,
      educational materials, goal-setting by a physician and dietician, and information about
      general community parks and recreation resources. After 6 months, control participants will
      receive invitation to participate in Bull City Fit. Subjects randomized to the intervention
      group will receive standard care as above plus invitation to participate in Bull City Fit.
      During the initial Healthy Lifestyle clinic appointment, the intervention participants will
      receive an introductory packet of information about Bull City Fit, and both the clinical
      providers and the research assistant will discuss the program verbally with the parent and
      child. The parent will be instructed to attend their first Bull City Fit session the Saturday
      subsequent to their clinical appointment, during which they will receive an orientation to
      the program and complete contracts that specify ground rules for the sessions (e.g., adult
      caregiver must accompany their child patient, cell phones are not allowed except for
      emergencies, etc.) and their commitment to actively participate.
    

Intervention name(s): Bull City Healthy and Fit; Healthy Lifestyles Clinic
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Integrated model of child obesity treatment including clinical care plus community-based program for family-based experiential learning of healthy habits.; Clinic-only model of care including clinical care and educational materials
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; treatment; community; integrated