Evidence map›Paper›PMID 32590958›Full record

ArticleBMC pediatrics2020

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 and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC pediatrics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03339440 (A Randomized Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.9field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03339440 nacompletednot on this map

A Randomized Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity

TypeinterventionalSponsorDuke UniversityRan2018 to 2021Enrolled327ConditionsChildhood Obesity, Pediatric Obesity, Quality of Life, Cardiovascular Risk FactorArmsHearts & Parks
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 13 citations in OpenAlex.

  1. Observational
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 2 institutions in 1 country.

Sarah C ArmstrongDepartment of Pediatrics, Duke University, Durham, NC, 27710, USA.
McAllister WindomDepartment of Pediatrics, Duke University, Durham, NC, 27710, USA.
Nathan A BihlmeyerDuke Molecular Physiology Institute, Duke University, Durham, NC, 27710, USA.
Jennifer S LiDepartment of Pediatrics, Duke University, Durham, NC, 27710, USA.
Svati H ShahDuke Molecular Physiology Institute, Duke University, Durham, NC, 27710, USA.
Mary StoryDepartment of Family Medicine and Community Health, Duke University, Durham, NC, 27710, USA.
Nancy ZuckerDepartment of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, 27710, USA.
William E KrausDepartment of Medicine, Duke University, Durham, NC, 27710, USA.
Neha PagidipatiDuke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.
Eric PetersonDuke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.
Charlene WongDepartment of Pediatrics, Duke University, Durham, NC, 27710, USA.
Manuela WiedemeierDuke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.
Lauren SibleyUniversity of North Carolina School of Medicine, Chapel Hill, NC, 27516, USA.
Samuel I BerchuckDepartment of Statistical Science, Duke University, Durham, NC, 27710, USA.
Peter MerrillDuke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.
Alexandra ZizziDepartment of Pediatrics, Duke University, Durham, NC, 27710, USA.
Charles SarriaDepartment of Pediatrics, Duke University, Durham, NC, 27710, USA.
Holly K DressmanDepartment of Molecular Genetics and Microbiology, Duke University, Durham, NC, 27708, USA.
John F RawlsDepartment of Molecular Genetics and Microbiology, Duke University, Durham, NC, 27708, USA.
Asheley C SkinnerDuke Clinical Research Institute, Duke University, Durham, NC, 27710, USA. asheley.skinner@duke.edu.ORCID 0000-0002-7737-9181
Duke University · USUniversity of North Carolina at Chapel Hill · US

Funding

American Heart Association 17SFRN33670990American Heart Association 17SFRN33671003American Heart Association 17SFRN33700117American Heart Association 17SFRN33700155
6 · The paper itself

Abstract

backgroundThe 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.

methodsMethods 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 registrationNCT03339440 .

Indexed as

Pediatric ObesityAdolescentBody Mass IndexChildFamilyHumansLife StylePragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicAdolescentsCardiovascularChildrenCommunityFitnessObesityParks and recreationPartnershipPediatricQuality of life

Identifiers

PMID32590958
PMCPMC7318397
OpenAlexW3037336986

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.