Integrated Child Obesity Treatment Study: Bull City Healthy and Fit
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 5 - 11 |
| Updated: | 4/21/2016 |
| Start Date: | October 2015 |
| End Date: | October 2017 |
| Contact: | Sarah C Armstrong, MD |
| Email: | sarah.c.armstrong@duke.edu |
| Phone: | 919-620-5394 |
A Novel Healthcare-Community Partnership for Childhood Obesity Treatment: A Randomized Pilot Study
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.
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.
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.
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.
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)
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