NCT07039630

A Food Security Intervention for the Prevention of Cancer in Low-income Families

A Sustainable Nutrition Security Intervention for Low-Income Households

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is being done to see how produce delivery with or without nutritional education affects what people eat and if it can help improve diet and nutrition in low-income families and their ability to get enough healthy food. Research shows strong evidence regarding the role of diet in new cancer rates and cancer deaths. Although dietary guidelines have been established at the national level to improve diet quality, the average dietary quality remains low in American households, particularly in low-income communities. These disadvantaged communities are also more likely to be food insecure (having limited or uncertain access to nutritious food). FreshFix is a community-based organization that provides nutritious foods from local farmers to communities in Western New York and offers a Half-Price Produce delivery program which is targeted for lower-income and underserved communities. Participating in the FreshFix program with access to nutritional education materials may decrease food insecurity and improve diet quality in low-income families.

Detailed description

PRIMARY OBJECTIVES: I. To develop a nutrition security intervention to improve the nutrition security of low-income households. II. To determine the feasibility of the nutrition security intervention. SECONDARY OBJECTIVE: I. To refine the intervention by engaging community-based organizations and households enrolled in the nutrition security intervention to ascertain the barriers and facilitators of intervention implementation. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive enhanced delivery half-price food boxes delivered by a community health worker and assistance on the proper handling and storage of the food over 24 weeks on study. Participants receive nutritional education materials and access to additional educational resources on the FreshFix online ordering platform. Participants also receive a dietary recall phone call at baseline and at 6 months on study. ARM II: Participants receive the standard half-price produce box delivery delivered by FreshFix staff over 24 weeks on study.

Conditions

• Obesity-Related Malignant Neoplasm

Interventions

Type	Name	Description
BEHAVIORAL	Food Assistance Programs	Receive enhanced delivery half-price food boxes delivered by a community health worker
BEHAVIORAL	Food Assistance Programs	Receive the standard half-price produce box delivery delivered by FreshFix staff
OTHER	Health Promotion and Education	Receive nutritional education materials and resources
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Survey Administration	Ancillary studies
BEHAVIORAL	Telephone-Based Intervention	Receive a dietary recall phone call

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-05-30
• Completion: 2027-05-30
• First posted: 2025-06-26
• Last updated: 2026-03-17

Locations

1 site across 1 country: United States