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

Adolescent Body Mass Index Child Family Humans Life Style Pediatric Obesity / therapy Quality of Life Randomized Controlled Trials as Topic
Adolescents Cardiovascular Children Community Fitness Obesity Parks and recreation Partnership Pediatric Quality of life

Journal

BMC pediatrics
ISSN: 1471-2431
Titre abrégé: BMC Pediatr
Pays: England
ID NLM: 100967804

Informations de publication

Date de publication:
26 06 2020
Historique:
received: 14 04 2020
accepted: 02 06 2020
entrez: 28 6 2020
pubmed: 28 6 2020
medline: 15 5 2021
Statut: epublish

Résumé

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 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. 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. NCT03339440 .

Sections du résumé

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 .

Identifiants

DOI: 10.1186/s12887-020-02190-x PMID: 32590958 PMC: PMC7318397
pubmed: 32590958
doi: 10.1186/s12887-020-02190-x
pii: 10.1186/s12887-020-02190-x
pmc: PMC7318397
doi:

Banques de données

ClinicalTrials.gov
['NCT03339440']

Types de publication

Clinical Trial Protocol Journal Article Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

308

Subventions

Organisme : American Heart Association
ID : 17SFRN33700117
Pays : International
Organisme : American Heart Association
ID : 17SFRN33670990
Pays : International
Organisme : American Heart Association
ID : 17SFRN33671003
Pays : International
Organisme : American Heart Association
ID : 17SFRN33700155
Pays : International

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Auteurs

Sarah C Armstrong (SC)

Department of Pediatrics, Duke University, Durham, NC, 27710, USA.
Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.

McAllister Windom (M)

Department of Pediatrics, Duke University, Durham, NC, 27710, USA.

Nathan A Bihlmeyer (NA)

Duke Molecular Physiology Institute, Duke University, Durham, NC, 27710, USA.

Jennifer S Li (JS)

Department of Pediatrics, Duke University, Durham, NC, 27710, USA.

Svati H Shah (SH)

Duke Molecular Physiology Institute, Duke University, Durham, NC, 27710, USA.
Department of Medicine, Duke University, Durham, NC, 27710, USA.

Mary Story (M)

Department of Family Medicine and Community Health, Duke University, Durham, NC, 27710, USA.

Nancy Zucker (N)

Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, 27710, USA.

William E Kraus (WE)

Department of Medicine, Duke University, Durham, NC, 27710, USA.

Neha Pagidipati (N)

Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.
Department of Medicine, Duke University, Durham, NC, 27710, USA.

Eric Peterson (E)

Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.
Department of Medicine, Duke University, Durham, NC, 27710, USA.

Charlene Wong (C)

Department of Pediatrics, Duke University, Durham, NC, 27710, USA.
Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.

Manuela Wiedemeier (M)

Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.

Lauren Sibley (L)

University of North Carolina School of Medicine, Chapel Hill, NC, 27516, USA.

Samuel I Berchuck (SI)

Department of Statistical Science, Duke University, Durham, NC, 27710, USA.

Peter Merrill (P)

Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.

Alexandra Zizzi (A)

Department of Pediatrics, Duke University, Durham, NC, 27710, USA.

Charles Sarria (C)

Department of Pediatrics, Duke University, Durham, NC, 27710, USA.

Holly K Dressman (HK)

Department of Molecular Genetics and Microbiology, Duke University, Durham, NC, 27708, USA.

John F Rawls (JF)

Department of Molecular Genetics and Microbiology, Duke University, Durham, NC, 27708, USA.

Asheley C Skinner (AC)

Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA. asheley.skinner@duke.edu.
Department of Population Health Sciences, Duke University, 215 Morris Street, Suite 210, Durham, NC, 27701, USA. asheley.skinner@duke.edu.
ORCID: 0000-0002-7737-9181

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adolescent › Rationale and design of "Hearts & Parks":...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Mesures épidémiologiques › Biométrie › Anthropométrie › Indice de masse corporelle › Rationale and design of "Hearts & Parks":...
questionsmedicales.fr › Personnes › Tranches d'âge › Enfant › Rationale and design of "Hearts & Parks":...
questionsmedicales.fr › Sciences sociales › Sociologie › Facteurs sociologiques › Famille › Rationale and design of "Hearts & Parks":...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Rationale and design of "Hearts & Parks":...
questionsmedicales.fr › Comportement et mécanismes comportementaux › Mode de vie › Rationale and design of "Hearts & Parks":...
questionsmedicales.fr › États, signes et symptômes pathologiques › Signes et symptômes › Obésité › Obésité pédiatrique › Rationale and design of "Hearts & Parks":...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Mesures épidémiologiques › Démographie › État de santé › Qualité de vie › Rationale and design of "Hearts & Parks":...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › Rationale and design of "Hearts & Parks":...