Nourishing Beginnings: Addressing Food Insecurity During Pregnancy

Not Applicable

Recruiting

• Conditions: Pregnancy Related; Pregnancy Complications; Food Insecurity; Premature Birth

• Registration Number: NCT05341960
• Lead Sponsor: Case Western Reserve University

Brief 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.

Study Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-22
• Study Start: 2022-07-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-06
• Primary Completion: 2026-02-28
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 124

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Food Insecurity	Change from baseline to delivery	6 item, USDA measure; dichotomous outcome
Maternal depression	Change from baseline to delivery	9 item, self-administered, assesses maternal depression
Neonatal Intensive Care (NICU) Utilization	From date of NICU admission to date of discharge from NICU or death, which ever comes first, up to 100 months	number of days baby was admitted to NICU
Baby Gestational Age	At delivery	Baby's gestational age at birth, measured in weeks
Social Support	Change from baseline to delivery	6 item, self-administered, assesses emotional and instrumental social support
Mastery	Change from baseline to delivery	7 item, self-administered, assesses skill development and control
Baby Birthweight	At delivery	Baby's birthweight, measured in grams
Days Hospitalization	From date of delivery to date of baby discharge from hospital or death, which ever comes first, up to 100 months	total number of days baby was hospitalized following birth

Trial Locations

Locations (2)

Mom's First; 🇺🇸 Cleveland, Ohio, United States

Better Health Partnership CHW HUB; 🇺🇸 Cleveland, Ohio, United States