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COMPLETED
NCT04724330
NA

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

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

534

Start Date

2021-03-15

Completion Date

2025-06-25

Last Updated

2026-07-02

Healthy Volunteers

No

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.

Locations (1)

Johns Hopkins Health System and University

Baltimore, Maryland, United States