Nourishing Beginnings: Addressing Food Insecurity During Pregnancy

Case Western Reserve University

Status: Enrolling

Conditions: Pregnancy Complications; Pregnancy Related; Food Insecurity; Premature Birth

Treatments: Behavioral: Food Delivery; Other: Financial Support

Study type: Interventional

Funder types: Other

Identifiers

NCT05341960

STUDY20211072

Details and patient eligibility

About

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

Full 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.

Enrollment: 124 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 3 patient groups

Food Delivery

Experimental group

Description:

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

Treatment:

Behavioral: Food Delivery

Financial Support and Navigation

Experimental group

Description:

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

Treatment:

Other: Financial Support

Control Group

No Intervention group

Description:

Selected from claims data, matched.