CompletedNot Applicable

Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy

United States240 participantsStarted 2024-04-29

Plain-language summary

This study is being done to find out if online referrals to a food management program for Women, Infants, and Children (WIC) made by clinical teams will get more people to enroll in WIC. Women aged 18 or older who get healthcare at Geisinger, are pregnant, and are eligible to be referred to the WIC program will be recruited. These women need to consent to join this study. There are four groups in this study. Group 1 will get usual care with details about WIC from their clinical team. Group 2 will be sent to WIC by their clinical team. The study team may help the clinical team with the referrals. Group 3 will get details about WIC from their clinical team and a dietitian will talk to them about heart-healthy diets and food management. Group 4 will be sent to WIC by their clinical team or study team and a dietitian will talk to them about heart-healthy diets and food management. Participants who talk with the dietitians will be sent kitchen utensils based on need. This study will last about 18 months and will have 240 total subjects joining at about 60 per month. Each subject will be in the study for about 6 months. Subjects will be asked to complete surveys at the start and end of the study. Some subjects will also be asked about their experience in the study after they are done.

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: * English speaking * Confirmed pregnancy * Public Insurance (Medicaid) OR no insurance * If no insurance, must meet income eligibility for WIC * Intent to deliver at a Geisinger facility * Able and willing to provide consent Exclusion Criteria: * Pre-existing WIC enrollment as a pregnant person * Not eligible for WIC * Private insurance * Unwilling to participate for up to 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.

What they're measuring

Difference in Women, Infants, and Children (WIC) enrollment

Timeframe: 6 months

Trial details

NCT IDNCT06311799

SponsorGeisinger Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Cardiovascular Diseases trials