Advancing Health Equity by Integrating Social-Clinical Models During Pregnancy

NCT06311799 | Completed

• 1 other identifier: 2024-0102
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases; Obesity, Maternal; Diabetes

Outcome Measures

Primary Outcomes (1)

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

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

  6 months

Secondary Outcomes (4)

• WIC retention

  6 months

• WIC adherence

  6 months

• Prenatal clinic visit adherence.

  6 months

• Registered Dietitian/Nutritionist (RDN) visit adherence

  6 months

Study Arms (4)

Arm 1: Clinic Model

NO INTERVENTION

Clinical team gives WIC information only

Arm 2: Clinic-WIC Model

ACTIVE COMPARATOR

Clinical team connects patient to WIC

Behavioral: WIC Referral

Arm 3: Clinic-RDN Model

ACTIVE COMPARATOR

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

Behavioral: RDN Referral

Arm 4: Clinic-WIC-RDN

ACTIVE COMPARATOR

Clinical team connects patient to WIC and RDN

Behavioral: WIC Referral; Behavioral: RDN Referral

Interventions

WIC Referral BEHAVIORAL

Clinical team will refer study participants to WIC

Arm 2: Clinic-WIC Model; Arm 4: Clinic-WIC-RDN

RDN Referral BEHAVIORAL

Clinical team will refer study participants to a RDN

Arm 3: Clinic-RDN Model; Arm 4: Clinic-WIC-RDN

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pre-existing WIC enrollment as a pregnant person
• Not eligible for WIC
• Private insurance
• Unwilling to participate for up to 12 months

Sponsors & Collaborators

• Geisinger Clinic: lead
• American Heart Association: collaborator
• Family Health Council of Central Pennsylvania (FHCCP): collaborator

Study Sites (1)

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

Related Publications (1)

• Herb Neff KM, Brandt K, Chang AR, Lutcher S, Mackeen AD, Marshall KA, Naylor A, Seiler CJ, Wood GC, Wright L, Bailey-Davis L. Comparing models that integrate obstetric care and WIC on improved program enrollment during pregnancy: a protocol for a randomized controlled trial. BMC Public Health. 2024 Dec 5;24(1):3393. doi: 10.1186/s12889-024-20509-6.

  PMID: 39639285 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Pregnancy in Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lisa D Bailey-Davis

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: April 29, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be made available immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data may access for any purpose.

Locations

US (1)