Healthy for Two-Home Visiting (H42-HV): Health Coaching for Pregnant Women (NCT05619705) | Clinical Trial Compass
RecruitingNot Applicable
Healthy for Two-Home Visiting (H42-HV): Health Coaching for Pregnant Women
United States360 participantsStarted 2023-04-25
Plain-language summary
The purpose of this study is to compare the effectiveness of H42-HV integrated into home visiting compared with usual home visiting services in reducing postpartum weight retention (difference between pre-pregnancy weight and weight at 6 months postpartum) among pregnant and postpartum participants. The overall goal is to improve long-term cardiometabolic health.
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:
* Pregnant, ≤33 weeks gestation
* Singleton pregnancy
* Pre pregnancy BMI≥25.0 Kg/m\^2 (calculated based on self-reported pre pregnancy height and weight)
* Able to provide informed consent
* English or Spanish speaking
* Completion of screening and baseline data collection
* Willing to participate in the intervention and data collection procedure (e.g., home weights)
Exclusion Criteria:
* Type 1 diabetes or taking insulin prior to delivery
* Pregnant with multiple fetuses
* Unable to walk 1 block without pain or shortness of breath
* Not cleared by the study's clinicians or home visiting program staff
* Planning to relocate from area during next 1 year
* Active substance abuse disorder (except marijuana)
* Psychiatric or substance use related hospitalization in past 1 year
* Active eating disorder
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.