Improving food access for pregnant individuals
Nourishing Beginnings: Addressing Food Insecurity Among Medicaid-Eligible Pregnant Individuals
This study is testing whether providing pregnant individuals with direct food delivery or financial help to access healthy foods can improve their eating habits and health during pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Case Western Reserve University Academic / other |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Trial ID | NCT05341960 on ClinicalTrials.gov |
What this trial studies
This pilot project aims to test the feasibility of a community health worker-led intervention designed to enhance access to nutritious food for pregnant individuals. It will enroll 160 participants who are Medicaid eligible and randomly assign them to either receive direct food delivery or financial resources with navigation support for accessing healthy foods. The study will evaluate the effectiveness of these interventions on dietary behavior, psychosocial health, and birth outcomes, using a combination of primary and secondary data sources. The project is conducted in collaboration with local organizations to address food insecurity during pregnancy.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals under 22 weeks gestation who are Medicaid eligible and can engage with the community health worker hub.
Not a fit: Patients who are not Medicaid eligible or those who are beyond 22 weeks of gestation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve nutritional access and health outcomes for pregnant individuals facing food insecurity.
How similar studies have performed: Other studies have shown success with community health worker interventions in addressing social determinants of health, making this approach promising yet still somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Medicaid eligible * Enrolls in the CHW Hub * Able to read and understand English Exclusion Criteria: -
Where this trial is running
Cleveland, Ohio and 1 other locations
- Mom's First — Cleveland, Ohio, United States (Recruiting)
- Better Health Partnership CHW HUB — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Elaine A Borawski, PhD — Case Western Reserve University
- Study coordinator: Elaine A Borawski, PhD
- Email: exb11@case.edu
- Phone: 216-368-1024
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.