What is the mechanism of action of this treatment?

Common treatments for food insecurity, such as the Community Health Worker-Led Intervention, work by improving access to nutritious food and providing education through community support. Community health workers (CHWs) educate patients on healthy eating, help them navigate food assistance programs, and offer ongoing support to ensure they have consistent access to healthy foods. These interventions increase knowledge about nutrition, improve access to food resources, and provide social support, which collectively address both immediate food needs and long-term dietary habits. This comprehensive approach is crucial for food insecurity patients as it enhances their overall health and well-being by ensuring they have the necessary resources and knowledge to maintain a nutritious diet.

What side effects are associated with this type of intervention?

Community Health Worker-led interventions aimed at improving nutritious food access and consumption generally have minimal side effects. However, potential challenges may include logistical issues such as inconsistent food supply, cultural barriers to dietary changes, and varying levels of participant engagement. Additionally, there may be psychological impacts such as stress or frustration if participants struggle to implement dietary changes or if the support provided does not meet their expectations. Overall, these interventions are considered safe and beneficial, with the primary focus on improving dietary habits and overall health.

What prior FDA approvals exist?

There are no FDA-approved drugs specifically for the treatment of food insecurity. However, interventions similar to the Community Health Worker-Led Intervention, which focuses on improving nutritious food access and consumption through community support and education, have been studied. These interventions typically involve community health workers providing education, resources, and support to improve dietary habits and access to nutritious foods. Such programs are often implemented in partnership with local organizations like food banks and health partnerships, rather than relying on pharmacological treatments.

What other types of research exist?

Promising novel alternatives to Community Health Worker-Led Interventions for food insecurity patients in 2024 include: 1) Mobile apps and online platforms that connect individuals with local food resources and provide nutrition education. 2) Policy initiatives that increase funding for food assistance programs and incentivize healthy food options in underserved areas. 3) Community gardens and urban farming projects that empower local communities to grow their own nutritious food. 4) Partnerships with local businesses and restaurants to redistribute surplus food to those in need. 5) Telehealth services offering remote nutritional counseling and support.

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Nutritional Support for Pregnant Individuals Facing Food Insecurity

N/A

Recruiting

Led By Elaine A Borawski, PhD

Research Sponsored by Case Western Reserve University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of nicu admission to date of discharge from nicu or death, which ever comes first, up to 100 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if community health workers can help pregnant women on Medicaid get and eat healthy food. Some participants will have food delivered to them, while others will receive support to buy healthy food. The goal is to see if this support improves their diet and health.

Who is the study for?

This trial is for pregnant individuals who are experiencing food insecurity, are eligible for Medicaid, and can read and understand English. They must enroll in the Community Health Worker (CHW) Hub to participate.

What is being tested?

The study tests a program where community health workers help improve access to nutritious food through direct food delivery and financial support. It's done with the Greater Cleveland Food Bank and Better Health Partnership CHW HUB.

What are the potential side effects?

Since this trial involves non-medical interventions like food delivery and financial support, traditional side effects associated with medications aren't expected. However, participants may experience changes in diet or stress levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of nicu admission to date of discharge from nicu or death, which ever comes first, up to 100 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of nicu admission to date of discharge from nicu or death, which ever comes first, up to 100 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of nicu admission to date of discharge from nicu or death, which ever comes first, up to 100 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Baby Birthweight

Baby Gestational Age

Days Hospitalization

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Food DeliveryExperimental Treatment1 Intervention

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

Group II: Financial Support and NavigationExperimental Treatment1 Intervention

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

Group III: Control GroupActive Control1 Intervention

Selected from claims data, matched.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Food Delivery

2005

Completed Phase 1

~960

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for food insecurity, such as the Community Health Worker-Led Intervention, work by improving access to nutritious food and providing education through community support. Community health workers (CHWs) educate patients on healthy eating, help them navigate food assistance programs, and offer ongoing support to ensure they have consistent access to healthy foods. These interventions increase knowledge about nutrition, improve access to food resources, and provide social support, which collectively address both immediate food needs and long-term dietary habits. This comprehensive approach is crucial for food insecurity patients as it enhances their overall health and well-being by ensuring they have the necessary resources and knowledge to maintain a nutritious diet.

Food assistance is associated with improved body mass index, food security and attendance at clinic in an HIV program in central Haiti: a prospective observational cohort study.