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Nourishing Beginnings: Addressing Food Insecurity During Pregnancy

Nourishing Beginnings: Addressing Food Insecurity During Pregnancy

Recruiting
18 years and older
Female
Phase N/A

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Overview

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

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.

Eligibility

Inclusion Criteria:

  • Medicaid eligible
  • Enrolls in the CHW Hub
  • Able to read and understand English

Exclusion Criteria:

-

Study details
    Pregnancy Related
    Food Insecurity
    Premature Birth
    Pregnancy Complications

NCT05341960

Case Western Reserve University

16 June 2025

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