MedTrace Logo

Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity

NCT04724330 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 534

Last updated 2026-04-07

No results posted yet for this study

Summary

Healthy for Two, Healthy for You (H42/H4U) is an innovative evidence-based pregnancy/postpartum health coach intervention that is remotely-delivered (phone coaching using motivational interviewing, web-based platform, mobile phone behavioral tracking). The aim of this randomized controlled trial (RCT) is to embed H42/H4U into Johns Hopkins prenatal care clinics that serve a racially and economically diverse population, leveraging existing staff as trained health coaches to test its effectiveness and implementation. The investigators hypothesize that women in the H42/H4U arm will have lower gestational weight gain and lower rates of gestational diabetes, without an increase in low birth weight infants, and that implementation into the investigators' prenatal care clinics will be feasible and scalable.

Conditions

  • Pregnancy Weight Gain
  • Postpartum Weight Retention
  • Childhood Obesity
  • Gestational Diabetes
  • Overweight and Obesity

Interventions

BEHAVIORAL

Healthy for Two/Healthy for You

\~10 month (early pregnancy to 12 weeks postpartum), remotely-delivered, behavioral lifestyle intervention including health coach contacts (via phone, videoconference, and email/MyChart) and an interactive web-based platform.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Wendy L Bennett, MD, MPH · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2025-01-31
Completion
2025-06-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04724330 on ClinicalTrials.gov