NCT04724330Completed
Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity
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
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 534 (actual)
- First submitted
- 22 Jan 2021
- Start date
- 15 Mar 2021
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- Johns Hopkins University
- Diseases
- Obesity
- NCT number
- NCT04724330
What you commit to
- Study type: Interventional
- Participants enrolled: 534
- From 15 Mar 2021 to the primary completion date, 31 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Other
- BMI \<25 kg/m2
- Multiple fetuses
- Poorly controlled blood pressure (\> 160/100 mmHg)
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Health System and University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.