Nourishing Beginnings: Addressing Food Insecurity During Pregnancy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy Related, Food Insecurity, Premature Birth, Pregnancy Complications

Intervention / Treatment
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* Behavioral: Food Delivery
* Other: Financial Support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medicaid eligible Enrolls in the CHW Hub Able to read and understand English Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Food Delivery<br>Food box delivered to participant home every 2 weeks until 6 weeks post delivery | Behavioral: Food Delivery<br>* 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.<br>|
| Experimental: Financial Support and Navigation<br>$30 provide on gift card every two weeks until 6 weeks post delivery + neighborhood food retail navigation support. | Other: Financial Support<br>* Provides supplemental funds to purchase healthy foods; provides choice. Includes recipes for limited budgets and assistance locating healthy food options in their specific neighborhood.<br>|
| No Intervention: Control Group<br>Selected from claims data, matched. | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prenatal Nutrition, Food Delivery, Social Determinants of Health, Food Insecurity, Community Health Workers