Nourishing Beginnings: Addressing Food Insecurity During Pregnancy

NCT05341960 | Active Not Recruiting

• 1 other identifier: STUDY20211072
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 2

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

Conditions

Pregnancy Related; Food Insecurity; Premature Birth; Pregnancy Complications

Keywords

Food Insecurity; Community Health Workers; Food Delivery; Prenatal Nutrition; Social Determinants of Health

Outcome Measures

Primary Outcomes (12)

• Food Insecurity

  6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome

  Change from baseline to 10 weeks post-randomization

• Food Insecurity

  6 item, USDA measure; dichotomous outcome

  Change from baseline to delivery

• Maternal depression

  9 item, self-administered, assesses maternal depression

  Change from baseline to 10 weeks post-randomization

• Maternal depression

  9 item, self-administered, assesses maternal depression

  Change from baseline to delivery

• Social Support

  6 item, self-administered, assesses emotional and instrumental social support

  Change from baseline to 10 weeks post-randomization

• Social Support

  6 item, self-administered, assesses emotional and instrumental social support

  Change from baseline to delivery

• Mastery

  7 item, self-administered, assesses skill development and locus of control

  Change from baseline to 10 weeks post-randomization

• Mastery

  7 item, self-administered, assesses skill development and control

  Change from baseline to delivery

• Baby Birthweight

  Baby's birthweight, measured in grams

  At delivery

• Baby Gestational Age

  Baby's gestational age at birth, measured in weeks

  At delivery

• 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

• 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

Study Arms (3)

Food Delivery

EXPERIMENTAL

Food box delivered to participant home every 2 weeks until 6 weeks post delivery

Behavioral: Food Delivery

Financial Support and Navigation

EXPERIMENTAL

$30 provide on gift card every two weeks until 6 weeks post delivery + neighborhood food retail navigation support.

Other: Financial Support

Control Group

NO INTERVENTION

Selected from claims data, matched.

Interventions

Food Delivery BEHAVIORAL

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.

Food Delivery

Financial Support OTHER

Provides supplemental funds to purchase healthy foods; provides choice. Includes recipes for limited budgets and assistance locating healthy food options in their specific neighborhood.

Financial Support and Navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Case Western Reserve University: lead
• Better Health Partnership: collaborator
• Greater Cleveland Food Bank: collaborator
• Pregnancy with Possibilities Resource Center: collaborator
• Village of Healing Center: collaborator
• United Way of Greater Cleveland: collaborator
• MetroHealth Medical Center: collaborator
• Cleveland Department of Public Health: collaborator

Study Sites (2)

Mom's First

Cleveland, Ohio, 44106, United States

Location

Better Health Partnership CHW HUB

Cleveland, Ohio, 44113, United States

Location

Related Publications (1)

• Borawski EA, Goodwin MA, Glenn AC, Mundorf C, Fernandez LI, Larberg N, Gunzler DD, Lever JS. Study design and protocol for Nourishing Beginnings, an integrated service delivery model addressing food insecurity and social needs of low-income pregnant individuals. Contemp Clin Trials. 2023 Oct;133:107310. doi: 10.1016/j.cct.2023.107310. Epub 2023 Aug 14.

  PMID: 37586560 DERIVED

MeSH Terms

Conditions

Premature Birth; Pregnancy Complications

Interventions

Financial Support

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Officials

• Elaine A Borawski, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Angela Bowen Williamson Professor of Community Nutrition

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 22, 2022
• Study Start: July 1, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (2)