Nourishing Beginnings: Addressing Food Insecurity During Pregnancy

Last updated: March 20, 2025
Sponsor: Case Western Reserve University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Treatment

Food Delivery

Financial Support

Clinical Study ID

NCT05341960
STUDY20211072
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Medicaid eligible

  • Enrolls in the CHW Hub

  • Able to read and understand English

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 124
Treatment Group(s): 2
Primary Treatment: Food Delivery
Phase:
Study Start date:
July 01, 2022
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • Better Health Partnership CHW HUB

    Cleveland, Ohio 44113
    United States

    Active - Recruiting

  • Mom's First

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

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