Pregnancy Related Clinical Trial
Official title:
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
Status | Recruiting |
Enrollment | 124 |
Est. completion date | February 28, 2026 |
Est. primary completion date | February 28, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Medicaid eligible - Enrolls in the CHW Hub - Able to read and understand English Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
United States | Better Health Partnership CHW HUB | Cleveland | Ohio |
United States | Mom's First | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Western Reserve University | Better Health Partnership, Greater Cleveland Food Bank, MetroHealth Medical Center, Mom's First - Cleveland Department of Public Health, Pregnancy with Possibilities Resource Center, United Way of Greater Cleveland, Village of Healing Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Food Insecurity | 6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome | Change from baseline to 10 weeks post-randomization | |
Primary | Food Insecurity | 6 item, USDA measure; dichotomous outcome | Change from baseline to delivery | |
Primary | Maternal depression | 9 item, self-administered, assesses maternal depression | Change from baseline to 10 weeks post-randomization | |
Primary | Maternal depression | 9 item, self-administered, assesses maternal depression | Change from baseline to delivery | |
Primary | Social Support | 6 item, self-administered, assesses emotional and instrumental social support | Change from baseline to 10 weeks post-randomization | |
Primary | Social Support | 6 item, self-administered, assesses emotional and instrumental social support | Change from baseline to delivery | |
Primary | Mastery | 7 item, self-administered, assesses skill development and locus of control | Change from baseline to 10 weeks post-randomization | |
Primary | Mastery | 7 item, self-administered, assesses skill development and control | Change from baseline to delivery | |
Primary | Baby Birthweight | Baby's birthweight, measured in grams | At delivery | |
Primary | Baby Gestational Age | Baby's gestational age at birth, measured in weeks | At delivery | |
Primary | Neonatal Intensive Care (NICU) Utilization | 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 | |
Primary | Days Hospitalization | 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 |
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