Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity
Completed · Not applicable
Conditions studied: Pregnancy Weight Gain, Postpartum Weight Retention, Childhood Obesity, Gestational Diabetes, Overweight and Obesity
In brief
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.
Key facts
- Study ID
- NCT04724330
- Run by
- Johns Hopkins University
- People needed
- 534
- Starts
- 2021-03-15
- Expected to finish
- 2025-06-25
- Last updated by the study team
- 2026-07-02
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age≥18
- Singleton pregnancy
- ≤15 weeks gestation with documented prenatal weight and height in electronic health record
- Body mass index ≥ 25.0 kg/m2
- English-speaking
- Has smartphone, laptop or tablet and willing to use it for this study
- Has email address and willing to use for this study
You may not qualify if…
- BMI <25 kg/m2
- Multiple fetuses
- History of pre-gestational Type 1 or Type 2 diabetes or taking diabetes medication for treatment of diabetes prior to first prenatal visit
- Prior history of severe preeclampsia, pre-term birth (< 32 weeks gestation)
- Poorly controlled blood pressure (> 160/100 mmHg)
- Substance use disorder or positive urine toxicology (except for THC) for illicit substances (screening done as part of routine care)
- Psychiatric hospitalization in last 12 months or diagnosis of severe mental illness that is not well controlled
- Active diagnosis of an eating disorder
- Unable to walk 1 block without pain or shortness of breath
- No email address
- Unable to speak or read in English
- Planning to move in next 12 months
Where it is running
- Johns Hopkins Health System and University — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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