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

Publication ,  Journal Article
Armstrong, SC; Windom, M; Bihlmeyer, NA; Li, JS; Shah, SH; Story, M; Zucker, N; Kraus, WE; Pagidipati, N; Peterson, E; Wong, C; Wiedemeier, M ...
Published in: BMC Pediatr
June 26, 2020

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 .

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Published In

BMC Pediatr

DOI

EISSN

1471-2431

Publication Date

June 26, 2020

Volume

20

Issue

1

Start / End Page

308

Location

England

Related Subject Headings

  • Randomized Controlled Trials as Topic
  • Quality of Life
  • Pediatrics
  • Pediatric Obesity
  • Life Style
  • Humans
  • Family
  • Child
  • Body Mass Index
  • Adolescent
 

Citation

APA
Chicago
ICMJE
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Armstrong, S. C., Windom, M., Bihlmeyer, N. A., Li, J. S., Shah, S. H., Story, M., … Skinner, A. C. (2020). Rationale and design of "Hearts & Parks": study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity. BMC Pediatr, 20(1), 308. https://doi.org/10.1186/s12887-020-02190-x
Armstrong, Sarah C., McAllister Windom, Nathan A. Bihlmeyer, Jennifer S. Li, Svati H. Shah, Mary Story, Nancy Zucker, et al. “Rationale and design of "Hearts & Parks": study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity.BMC Pediatr 20, no. 1 (June 26, 2020): 308. https://doi.org/10.1186/s12887-020-02190-x.
Armstrong, Sarah C., et al. “Rationale and design of "Hearts & Parks": study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity.BMC Pediatr, vol. 20, no. 1, June 2020, p. 308. Pubmed, doi:10.1186/s12887-020-02190-x.
Armstrong SC, Windom M, Bihlmeyer NA, Li JS, Shah SH, Story M, Zucker N, Kraus WE, Pagidipati N, Peterson E, Wong C, Wiedemeier M, Sibley L, Berchuck SI, Merrill P, Zizzi A, Sarria C, Dressman HK, Rawls JF, Skinner AC. Rationale and design of "Hearts & Parks": study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity. BMC Pediatr. 2020 Jun 26;20(1):308.
Journal cover image

Published In

BMC Pediatr

DOI

EISSN

1471-2431

Publication Date

June 26, 2020

Volume

20

Issue

1

Start / End Page

308

Location

England

Related Subject Headings

  • Randomized Controlled Trials as Topic
  • Quality of Life
  • Pediatrics
  • Pediatric Obesity
  • Life Style
  • Humans
  • Family
  • Child
  • Body Mass Index
  • Adolescent