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

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, 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

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: NCT03339440 .

Keywords: Adolescents; Cardiovascular; Children; Community; Fitness; Obesity; Parks and recreation; Partnership; Pediatric; Quality of life.

Conflict of interest statement

Sarah C. Armstrong: Dr. Armstrong has research supported by Astra Zeneca. She is a member of the Data Safety and Monitoring Committee for Novo Nordisk. She is a paid speaker for Rhythm Pharmaceuticals.

McAllister Windom: Declaration of interest—none.

Nathan A. Bihlmeyer: Declaration of interest—none.

Jennifer S. Li: Declaration of interest—none.

Svati H. Shah: Declaration of interest—none.

Mary Story: Declaration of interest—none.

Nancy Zucker: Declaration of interest—none.

William E. Kraus: Declaration of interest—none.

Neha Pagidipati: Dr. Pagidipati reports research grants from: Alexion Pharmaceuticals, Inc.; Amarin Pharmaceutical Company; Amgen, Inc.; AstraZeneca; Baseline Study LLC; Boehringer Ingleheim; Duke Clinical Research Institute; Eli Lilly & Company; Novo Nordisk Pharmaceutical Company; Regeneron Pharmaceuticals, Inc.; Sanofi-S.A.; Verily Sciences Research Company. She reports consulting fees from AstraZeneca.

Eric Peterson: Dr. Peterson Receives research support from Amgen, Janssen, Astra Zeneca, and Sanofi and receives consulting support from Amgen, Sanofi, Janssen. He also is on the advisory board for Cerner and Livogo.

Charlene Wong: Dr. Wong has research supported by Verily Life Sciences.

Manuela Wiedemeier: Declaration of interest—none.

Lauren Sibley: Declaration of interest—none.

Samuel Berchuck: Declaration of interest—none.

Peter Merrill: Declaration of interest—none.

Alexandra Zizzi: Declaration of interest—none.

Charles Sarria: Declaration of interest—none.

Holly K. Dressman: Declaration of interest—none.

John F. Rawls: Declaration of interest—none.

Asheley C. Skinner: Declaration of interest—none.

Figures

Fig. 1
Fig. 1
Hearts and Parks Study Diagram
Fig. 2
Fig. 2
Overview of expansion of R24 Cohort by the newly funded Duke Center for Pediatric Obesity Research (American Heart Association Strategically Focused Research Network). Outline of which samples come from which cohort and age-group. Obese/lean is also listed. Only obese individuals will have follow-up samples collected

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