Nourishing Beginnings: Addressing Food Insecurity During Pregnancy
NCT ID: NCT05341960
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
124 participants
INTERVENTIONAL
2022-07-01
2026-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Food Delivery
Food box delivered to participant home every 2 weeks until 6 weeks post delivery
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.
Financial Support and Navigation
$30 provide on gift card every two weeks until 6 weeks post delivery + neighborhood food retail navigation support.
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.
Control Group
Selected from claims data, matched.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Enrolls in the CHW Hub
* Able to read and understand English
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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Better Health Partnership
UNKNOWN
Greater Cleveland Food Bank
UNKNOWN
Pregnancy with Possibilities Resource Center
UNKNOWN
Village of Healing Center
UNKNOWN
United Way of Greater Cleveland
UNKNOWN
MetroHealth Medical Center
OTHER
Cleveland Department of Public Health
UNKNOWN
Case Western Reserve University
OTHER
Responsible Party
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Elaine Borawski
Angela Bowen Williamson Professor of Community Nutrition
Principal Investigators
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Elaine A Borawski, PhD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Locations
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Mom's First
Cleveland, Ohio, United States
Better Health Partnership CHW HUB
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Christopher Mundorf, PHD
Role: primary
References
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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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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STUDY20211072
Identifier Type: -
Identifier Source: org_study_id
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