Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-29

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Cardiovascular Diseases Obesity, Maternal Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Arm 1: Clinic Model

Clinical team gives WIC information only

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm 2: Clinic-WIC Model

Clinical team connects patient to WIC

Group Type ACTIVE_COMPARATOR

WIC Referral

Intervention Type BEHAVIORAL

Clinical team will refer study participants to WIC

Arm 3: Clinic-RDN Model

Clinical team gives WIC information only; connects patient to registered dietitian/nutritionist (RDN)

Group Type ACTIVE_COMPARATOR

RDN Referral

Intervention Type BEHAVIORAL

Clinical team will refer study participants to a RDN

Arm 4: Clinic-WIC-RDN

Clinical team connects patient to WIC and RDN

Group Type ACTIVE_COMPARATOR

WIC Referral

Intervention Type BEHAVIORAL

Clinical team will refer study participants to WIC

RDN Referral

Intervention Type BEHAVIORAL

Clinical team will refer study participants to a RDN

Interventions

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WIC Referral

Clinical team will refer study participants to WIC

Intervention Type BEHAVIORAL

RDN Referral

Clinical team will refer study participants to a RDN

Intervention Type BEHAVIORAL

Eligibility Criteria

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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