Nourishing Beginnings: Addressing Food Insecurity During Pregnancy

April 14, 2026 updated by: Elaine Borawski, Case Western Reserve University

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Mom's First
      • Cleveland, Ohio, United States, 44113
        • Better Health Partnership CHW HUB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Food Delivery
Food box delivered to participant home every 2 weeks until 6 weeks post delivery
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.
Experimental: Financial Support and Navigation
$30 provide on gift card every two weeks until 6 weeks post delivery + neighborhood food retail navigation support.
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.
No Intervention: Control Group
Selected from claims data, matched.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food Insecurity
Time Frame: Change from baseline to 10 weeks post-randomization
6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome
Change from baseline to 10 weeks post-randomization
Food Insecurity
Time Frame: Change from baseline to delivery
6 item, USDA measure; dichotomous outcome
Change from baseline to delivery
Maternal depression
Time Frame: Change from baseline to 10 weeks post-randomization
9 item, self-administered, assesses maternal depression
Change from baseline to 10 weeks post-randomization
Maternal depression
Time Frame: Change from baseline to delivery
9 item, self-administered, assesses maternal depression
Change from baseline to delivery
Social Support
Time Frame: Change from baseline to 10 weeks post-randomization
6 item, self-administered, assesses emotional and instrumental social support
Change from baseline to 10 weeks post-randomization
Social Support
Time Frame: Change from baseline to delivery
6 item, self-administered, assesses emotional and instrumental social support
Change from baseline to delivery
Mastery
Time Frame: Change from baseline to 10 weeks post-randomization
7 item, self-administered, assesses skill development and locus of control
Change from baseline to 10 weeks post-randomization
Mastery
Time Frame: Change from baseline to delivery
7 item, self-administered, assesses skill development and control
Change from baseline to delivery
Baby Birthweight
Time Frame: At delivery
Baby's birthweight, measured in grams
At delivery
Baby Gestational Age
Time Frame: At delivery
Baby's gestational age at birth, measured in weeks
At delivery
Neonatal Intensive Care (NICU) Utilization
Time Frame: 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
From date of NICU admission to date of discharge from NICU or death, which ever comes first, up to 100 months
Days Hospitalization
Time Frame: 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
From date of delivery to date of baby discharge from hospital or death, which ever comes first, up to 100 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Collaborators

MetroHealth Medical Center
Better Health Partnership
Greater Cleveland Food Bank
Pregnancy with Possibilities Resource Center
Village of Healing Center
United Way of Greater Cleveland
Cleveland Department of Public Health

Investigators

  • Principal Investigator: Elaine A Borawski, PhD, Case Western Reserve University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

April 1, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20211072

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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