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BMC Pediatrics
Published in: BMC Pediatrics 1/2020

01-12-2020 | Obesity | Study protocol

Rationale and design of “Hearts & Parks”: study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity

Authors: Sarah C. Armstrong, McAllister Windom, Nathan A. Bihlmeyer, Jennifer S. Li, Svati H. Shah, Mary Story, Nancy Zucker, William E. Kraus, Neha Pagidipati, Eric Peterson, Charlene Wong, Manuela Wiedemeier, Lauren Sibley, Samuel I. Berchuck, Peter Merrill, Alexandra Zizzi, Charles Sarria, Holly K. Dressman, John F. Rawls, Asheley C. Skinner

Published in: BMC Pediatrics | Issue 1/2020

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Abstract

Background

The prevalence of child and adolescent obesity and severe obesity continues to increase despite decades of policy and research aimed at prevention. Obesity strongly predicts cardiovascular and metabolic disease risk; both begin in childhood. Children who receive intensive behavioral interventions can reduce body mass index (BMI) and reverse disease risk. However, delivering these interventions with fidelity at scale remains a challenge. Clinic-community partnerships offer a promising strategy to provide high-quality clinical care and deliver behavioral treatment in local park and recreation settings. The Hearts & Parks study has three broad objectives: (1) evaluate the effectiveness of the clinic-community model for the treatment of child obesity, (2) define microbiome and metabolomic signatures of obesity and response to lifestyle change, and (3) inform the implementation of similar models in clinical systems.

Methods

Methods are designed for a pragmatic randomized, controlled clinical trial (n = 270) to test the effectiveness of an integrated clinic-community child obesity intervention as compared with usual care. We are powered to detect a difference in body mass index (BMI) between groups at 6 months, with follow up to 12 months. Secondary outcomes include changes in biomarkers for cardiovascular disease, psychosocial risk, and quality of life. Through collection of biospecimens (serum and stool), additional exploratory outcomes include microbiome and metabolomics biomarkers of response to lifestyle modification.

Discussion

We present the study design, enrollment strategy, and intervention details for a randomized clinical trial to measure the effectiveness of a clinic-community child obesity treatment intervention. This study will inform a critical area in child obesity and cardiovascular risk research—defining outcomes, implementation feasibility, and identifying potential molecular mechanisms of treatment response.

Clinical trial registration

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Metadata
Title
Rationale and design of “Hearts & Parks”: study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity
Authors
Sarah C. Armstrong
McAllister Windom
Nathan A. Bihlmeyer
Jennifer S. Li
Svati H. Shah
Mary Story
Nancy Zucker
William E. Kraus
Neha Pagidipati
Eric Peterson
Charlene Wong
Manuela Wiedemeier
Lauren Sibley
Samuel I. Berchuck
Peter Merrill
Alexandra Zizzi
Charles Sarria
Holly K. Dressman
John F. Rawls
Asheley C. Skinner
Publication date
01-12-2020
Publisher
BioMed Central
Published in
BMC Pediatrics / Issue 1/2020
Electronic ISSN: 1471-2431
DOI
https://doi.org/10.1186/s12887-020-02190-x

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