Nourishing Beginnings: Addressing Food Insecurity During Pregnancy

Sponsor

Case Western Reserve University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05341960

Collaborator

(none)

124

Enrollment

Location

Arms

26.1

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related Food Insecurity Premature Birth Pregnancy Complications	Behavioral: Food Delivery Other: Financial Support	N/A

Detailed Description

The Nourishing Beginnings pilot study will enroll 124 pregnant (<22 weeks gestation) who are eligible to use the Hub (i.e., Medicaid eligible). Participants will be randomly assigned into one of two intervention arms - either direct food delivery (n=62) or small financial resources and individualized navigation support for accessing local healthy foods (n=62).

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Food Delivery Food box delivered to participant home every 2 weeks until 6 weeks post delivery	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.
Experimental: Financial Support and Navigation $30 provide on gift card every two weeks until 6 weeks post delivery + neighborhood food retail navigation support.	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.
No Intervention: Control Group Selected from claims data, matched.

Arm

Intervention/Treatment

Experimental: Food Delivery

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

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.

Experimental: Financial Support and Navigation

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

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.

No Intervention: Control Group

Selected from claims data, matched.

Outcome Measures

Primary Outcome Measures

Food Insecurity [Change from baseline to 10 weeks post-randomization]
6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome
Food Insecurity [Change from baseline to delivery]
6 item, USDA measure; dichotomous outcome
Maternal depression [Change from baseline to 10 weeks post-randomization]
9 item, self-administered, assesses maternal depression
Maternal depression [Change from baseline to delivery]
9 item, self-administered, assesses maternal depression
Social Support [Change from baseline to 10 weeks post-randomization]
6 item, self-administered, assesses emotional and instrumental social support
Social Support [Change from baseline to delivery]
6 item, self-administered, assesses emotional and instrumental social support
Mastery [Change from baseline to 10 weeks post-randomization]
7 item, self-administered, assesses skill development and locus of control
Mastery [Change from baseline to delivery]
7 item, self-administered, assesses skill development and control
Baby Birthweight [At delivery]
Baby's birthweight, measured in grams
Baby Gestational Age [At delivery]
Baby's gestational age at birth, measured in weeks
Neonatal Intensive Care (NICU) Utilization [From date of NICU admission to date of discharge from NICU or death, which ever comes first, up to 100 months]
number of days baby was admitted to NICU
Days Hospitalization [From date of delivery to date of baby discharge from hospital or death, which ever comes first, up to 100 months]
total number of days baby was hospitalized following birth