Nourishing Beginnings: Addressing Food Insecurity During Pregnancy

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05341960
• Other study ID #: STUDY20211072
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: February 28, 2026

Study information

• Verified date: June 2024
• Source: Case Western Reserve University
• Contact: Elaine A Borawski, PhD
• Phone: 216-368-1024
• Email: exb11[@]case.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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:

-

Related Conditions & MeSH terms

• Food Insecurity
• Pregnancy Complications
• Pregnancy Related
• Premature Birth

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Better Health Partnership CHW HUB	Cleveland	Ohio
United States	Mom's First	Cleveland	Ohio

Sponsors (8)

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

Country where clinical trial is conducted

United States, 

Outcome

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