NCT05341960

Nourishing Beginnings: Addressing Food Insecurity During Pregnancy

Nourishing Beginnings: Addressing Food Insecurity Among Medicaid-Eligible Pregnant Individuals

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a pilot project designed to test the feasibility of implementing a community health worker (CHW)-led intervention to improve nutritious food access and consumption among pregnant people and to evaluate the effectiveness of this approach. The project will be conducted in partnership with the Greater Cleveland Food Bank and the Better Health Partnership Community Health Worker HUB

Detailed description

The Nourishing Beginnings pilot study will enroll 160 pregnant individuals (\<22 weeks gestation) who are eligible to use the Partnership Community HUB (i.e., Medicaid eligible). Participants will be randomly assigned into one of two intervention arms - either direct food delivery (n=80) or small financial resources and individualized navigation support for accessing local healthy foods (n=80). The pilot will (1) assess the feasibility and allow protocol refinement; (2) assess the preliminary impact of CHW-led intervention; and (3) conduct a rigorous process evaluation of the implementation of the intervention using an effectiveness-implementation hybrid type 1 design. Dietary behavior, psychosocial health, health care utilization, and health outcomes and birth outcomes will be tracked at baseline, mid-pregnancy, and at delivery, derived from both primary and secondary data sources (i.e., Hub and claims data). Critical implementation points (referral, CHW touch points, and food delivery) will be assessed. Intervention arms will be compared to a matched comparison group derived from local claims data for the same time period.

Conditions

• Pregnancy Related
• Food Insecurity
• Premature Birth
• Pregnancy Complications

Interventions

Type	Name	Description
BEHAVIORAL	Food Delivery	Food box with food to feed a family of four, delivered by the Greater Cleveland Food Bank every two weeks. Based on participant preferences, includes recipes.
OTHER	Financial Support	Provides supplemental funds to purchase healthy foods; provides choice. Includes recipes for limited budgets and assistance locating healthy food options in their specific neighborhood.

Timeline

• Start date: 2022-07-01
• Primary completion: 2026-04-01
• Completion: 2026-07-31
• First posted: 2022-04-22
• Last updated: 2026-04-15

Locations

2 sites across 1 country: United States