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

Not Applicable

Not yet recruiting

• Conditions: Obesity-Related Malignant Neoplasm

• Registration Number: NCT07039630
• Lead Sponsor: Roswell Park Cancer Institute

Brief 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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Study Start: 2025-06-30
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Lives in Western New York (WNY)
• Is the person responsible for at least half of the food purchasing and preparation
• Categorized as having marginal, low of very low food security
• Able to access to internet and e-mail/text messages
• Speaks and understands English

Exclusion Criteria

• Participants that are unable to speak and understand English
• Participants that are unwilling or unable to follow protocol requirements
• Any condition which in the investigator's opinion deems the participant(s) is/are an unsuitable candidate to receive the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in nutrition security	Baseline to 24 weeks	Diet quality will be assessed by recall interview administered through the Nutrition Data System for Research.
Intervention acceptability	At 24 weeks	Conducted at 24 week follow up via phone or text based survey

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States