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Nourishing Beginnings: Addressing Food Insecurity During Pregnancy

Primary Purpose

Pregnancy Related, Food Insecurity, Premature Birth

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food Delivery
Financial Support
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pregnancy Related focused on measuring Food Insecurity, Community Health Workers, Food Delivery, Prenatal Nutrition, Social Determinants of Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Better Health Partnership CHW HUBRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Food Delivery

Financial Support and Navigation

Control Group

Arm Description

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

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

Selected from claims data, matched.

Outcomes

Primary Outcome Measures

Food Insecurity
6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome
Food Insecurity
6 item, USDA measure; dichotomous outcome
Maternal depression
9 item, self-administered, assesses maternal depression
Maternal depression
9 item, self-administered, assesses maternal depression
Social Support
6 item, self-administered, assesses emotional and instrumental social support
Social Support
6 item, self-administered, assesses emotional and instrumental social support
Mastery
7 item, self-administered, assesses skill development and locus of control
Mastery
7 item, self-administered, assesses skill development and control
Baby Birthweight
Baby's birthweight, measured in grams
Baby Gestational Age
Baby's gestational age at birth, measured in weeks
Neonatal Intensive Care (NICU) Utilization
number of days baby was admitted to NICU
Days Hospitalization
total number of days baby was hospitalized following birth

Secondary Outcome Measures

Full Information

First Posted
April 11, 2022
Last Updated
August 28, 2023
Sponsor
Case Western Reserve University
Collaborators
Better Health Partnership, Greater Cleveland Food Bank, Pregnancy with Possibilities Resource Center, Village of Healing Center, United Way of Greater Cleveland, MetroHealth Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05341960
Brief Title
Nourishing Beginnings: Addressing Food Insecurity During Pregnancy
Official Title
Nourishing Beginnings: Addressing Food Insecurity Among Medicaid-Eligible Pregnant Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
Collaborators
Better Health Partnership, Greater Cleveland Food Bank, Pregnancy with Possibilities Resource Center, Village of Healing Center, United Way of Greater Cleveland, MetroHealth Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Food Insecurity, Premature Birth, Pregnancy Complications
Keywords
Food Insecurity, Community Health Workers, Food Delivery, Prenatal Nutrition, Social Determinants of Health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Food Delivery
Arm Type
Experimental
Arm Description
Food box delivered to participant home every 2 weeks until 6 weeks post delivery
Arm Title
Financial Support and Navigation
Arm Type
Experimental
Arm Description
$30 provide on gift card every two weeks until 6 weeks post delivery + neighborhood food retail navigation support.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Selected from claims data, matched.
Intervention Type
Behavioral
Intervention Name(s)
Food Delivery
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Financial Support
Intervention Description
Provides supplemental funds to purchase healthy foods; provides choice. Includes recipes for limited budgets and assistance locating healthy food options in their specific neighborhood.
Primary Outcome Measure Information:
Title
Food Insecurity
Description
6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome
Time Frame
Change from baseline to 10 weeks post-randomization
Title
Food Insecurity
Description
6 item, USDA measure; dichotomous outcome
Time Frame
Change from baseline to delivery
Title
Maternal depression
Description
9 item, self-administered, assesses maternal depression
Time Frame
Change from baseline to 10 weeks post-randomization
Title
Maternal depression
Description
9 item, self-administered, assesses maternal depression
Time Frame
Change from baseline to delivery
Title
Social Support
Description
6 item, self-administered, assesses emotional and instrumental social support
Time Frame
Change from baseline to 10 weeks post-randomization
Title
Social Support
Description
6 item, self-administered, assesses emotional and instrumental social support
Time Frame
Change from baseline to delivery
Title
Mastery
Description
7 item, self-administered, assesses skill development and locus of control
Time Frame
Change from baseline to 10 weeks post-randomization
Title
Mastery
Description
7 item, self-administered, assesses skill development and control
Time Frame
Change from baseline to delivery
Title
Baby Birthweight
Description
Baby's birthweight, measured in grams
Time Frame
At delivery
Title
Baby Gestational Age
Description
Baby's gestational age at birth, measured in weeks
Time Frame
At delivery
Title
Neonatal Intensive Care (NICU) Utilization
Description
number of days baby was admitted to NICU
Time Frame
From date of NICU admission to date of discharge from NICU or death, which ever comes first, up to 100 months
Title
Days Hospitalization
Description
total number of days baby was hospitalized following birth
Time Frame
From date of delivery to date of baby discharge from hospital or death, which ever comes first, up to 100 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Medicaid eligible Enrolls in the CHW Hub Able to read and understand English Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine A Borawski, PhD
Phone
216-368-1024
Email
exb11@case.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Meredith Goodwin, PhD
Email
mag@case.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine A Borawski, PhD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Better Health Partnership CHW HUB
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Lever, MPH

12. IPD Sharing Statement

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Nourishing Beginnings: Addressing Food Insecurity During Pregnancy

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