Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity (NCT04724330) | Clinical Trial Compass
CompletedNot Applicable
Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity
United States534 participantsStarted 2021-03-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.