Evidence map›Paper›PMID 34896296›Full record

ArticleContemporary clinical trials2022

Healthy for Two/Healthy for You: Design and methods for a pragmatic randomized clinical trial to limit gestational weight gain and prevent obesity in the prenatal care setting.

Wendy L Bennett, Janelle W Coughlin, Janice Henderson, Stephen Martin, Golsa M Yazdy, Emmanuel F Drabo, Nakiya N Showell, Christine McKinney, Lindsay Martin, Arlene Dalcin and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04724330 (Healthy for 2/Healthy for U), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

NCT04724330 nacompletednot on this map

Healthy for 2/Healthy for U: A Pragmatic Randomized Clinical Trial to Limit Gestational Weight Gain and Prevent Obesity in Johns Hopkins Prenatal Care Practices

TypeinterventionalSponsorJohns Hopkins UniversityRan2021 to 2025Enrolled534ConditionsPregnancy Weight Gain, Postpartum Weight Retention, Childhood Obesity, Gestational DiabetesArmsHealthy for Two/Healthy for You
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
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

12 authors.

Wendy L BennettDepartment of Medicine, Division of General Internal Medicine, Johns Hopkins School of Medicine, 2024 E Monument Street, Baltimore, MD 21205, USA.. Electronic address: wendy.bennett@jhmi.edu.
Janelle W CoughlinDepartment of Psychiatry, Johns Hopkins School of Medicine, USA.
Janice HendersonDepartment of Gynecology and Obstetrics, Johns Hopkins School of Medicine, USA.
Stephen MartinDepartment of Gynecology and Obstetrics, Johns Hopkins School of Medicine, USA.
Golsa M YazdyDepartment of Gynecology and Obstetrics, Johns Hopkins School of Medicine, USA.
Emmanuel F DraboDepartment of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, USA.
Nakiya N ShowellDepartment of Pediatrics, Johns Hopkins School of Medicine, USA.
Christine McKinneyDepartment of Medicine, Division of General Internal Medicine, Johns Hopkins School of Medicine, 2024 E Monument Street, Baltimore, MD 21205, USA.
Lindsay MartinDepartment of Medicine, Division of General Internal Medicine, Johns Hopkins School of Medicine, 2024 E Monument Street, Baltimore, MD 21205, USA.
Arlene DalcinDepartment of Medicine, Division of General Internal Medicine, Johns Hopkins School of Medicine, 2024 E Monument Street, Baltimore, MD 21205, USA.
Rachel SandersDepartment of Medicine, Division of General Internal Medicine, Johns Hopkins School of Medicine, 2024 E Monument Street, Baltimore, MD 21205, USA.
Nae-Yuh WangDepartment of Medicine, Division of General Internal Medicine, Johns Hopkins School of Medicine, 2024 E Monument Street, Baltimore, MD 21205, USA.

Funding

Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
Healthy for 2/Healthy for U: A Pragmatic Randomized Clinical Trial to Limit Gestational Weight Gain and Prevent Obesity in the Prenatal Care SettingR18DK122416 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI BENNETT, WENDY LYNET · 2020 to 2024
$3.5M
NCATS NIH HHS UL1 TR001079NIDDK NIH HHS R18 DK122416
6 · The paper itself

Abstract

objectiveTo compare the effect of Healthy for Two/Healthy for You (H42/H4U), a health coaching program, in prenatal care clinics that serve a racially and economically diverse population, on total gestational weight gain (GWG) (vs. usual care). We hypothesize that compared to usual prenatal care, intervention participants will have lower GWG and lower rates of gestational diabetes mellitus (GDM).

methodsWe report the rationale and design of a pragmatic, parallel arm randomized clinical trial with 380 pregnant patients ≤15 weeks gestation with overweight or obesity from one of 6 academic and community-based obstetrics practices, randomized to either H42/H4U or usual prenatal care in a 1:1 ratio. The study duration is early pregnancy to 6 months postpartum. The primary outcome is total GWG, calculated as the difference between first clinic-assessed pregnancy weight and the weight at 37 weeks gestation. Key maternal and infant secondary outcomes include GDM incidence, weight retention at 6 months postpartum, infant weight, maternal health behaviors and wellness.

conclusionsThis pragmatic clinical trial embeds a pregnancy health coaching program into prenatal care to allow parallel testing compared to usual prenatal care on the outcome of total GWG. The real-world design provides an approach to enhance its sustainability beyond the trial to ultimately improve maternal/child health outcomes and reduce future obesity.

trial registrationThe study was first registered at clinicaltrials.gov on 1/26/21 (NCT04724330).

Indexed as

Gestational Weight GainPregnancy ComplicationsChildExerciseFemaleHumansInfantObesityOverweightPragmatic Clinical Trials as TopicPregnancyPrenatal CareRandomized Controlled Trials as TopicGestational weight gainLifestyle interventionObesityOverweightPostpartum weight retentionPregnancy

Identifiers

PMID34896296
PMCPMC8844210

What OpenQuestion holds

Textmetadata
LicenceTDM
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.