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Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity
Sponsor: Johns Hopkins University
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
Conditions
Interventions
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