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OpenTrials
Completed

NCT Number: NCT06311799

Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WIC Referral

Behavioral

Clinical team will refer study participants to WIC

RDN Referral

Behavioral

Clinical team will refer study participants to a RDN

Primary outcomes

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

    Time frame: 6 months

    Difference in WIC enrollment between Arm 1 and Arm 3 (Information only) vs Arm 2 and Arm 4 (digital connections)

Secondary outcomes

  1. WIC retention

    Time frame: 6 months

    Number of WIC benefit pick up visits completed

  2. WIC adherence

    Time frame: 6 months

    Frequency of redeeming WIC benefit

  3. Prenatal clinic visit adherence.

    Time frame: 6 months

    Number of prenatal clinic visits attended

  4. Registered Dietitian/Nutritionist (RDN) visit adherence

    Time frame: 6 months

    Number of RDN visits completed

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Collaborators

  • American Heart Association
  • Family Health Council of Central Pennsylvania (FHCCP)

Registry information

Acronym: FIMPreg

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2024
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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