Clinical trial NCT05341960: Nourishing Beginnings: Addressing Food Insecurity During Pregnancy
Official title: Nourishing Beginnings: Addressing Food Insecurity Among Medicaid-Eligible Pregnant Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Food Insecurity
Premature Birth
Pregnancy Complications
Keywords: Food Insecurity
Community Health Workers
Food Delivery
Prenatal Nutrition
Social Determinants of Health
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: Better Health Partnership
name: Greater Cleveland Food Bank
name: Pregnancy with Possibilities Resource Center
name: Village of Healing Center
name: United Way of Greater Cleveland
name: MetroHealth Medical Center
name: Cleveland Department of Public Health
First posted: 2022-04-22
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Food Insecurity
timeFrame: Change from baseline to 10 weeks post-randomization
measure: Food Insecurity
timeFrame: Change from baseline to delivery
measure: Maternal depression
timeFrame: Change from baseline to 10 weeks post-randomization
measure: Maternal depression
timeFrame: Change from baseline to delivery
measure: Social Support
timeFrame: Change from baseline to 10 weeks post-randomization
measure: Social Support
timeFrame: Change from baseline to delivery
measure: Mastery
timeFrame: Change from baseline to 10 weeks post-randomization
measure: Mastery
timeFrame: Change from baseline to delivery
measure: Baby Birthweight
timeFrame: At delivery
measure: Baby Gestational Age
timeFrame: At delivery
measure: Neonatal Intensive Care (NICU) Utilization
timeFrame: From date of NICU admission to date of discharge from NICU or death, which ever comes first, up to 100 months
measure: Days Hospitalization
timeFrame: From date of delivery to date of baby discharge from hospital or death, which ever comes first, up to 100 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Mom's First
state: Ohio
city: Cleveland
country: United States
facility: Better Health Partnership CHW HUB
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Elaine A Borawski, PhD
role: PRINCIPAL_INVESTIGATOR
References: