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

Roswell Park Comprehensive Cancer Center

Status: Suspended

Conditions: Obesity-Related Malignant Neoplasm

Treatments: Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention; Behavioral: Food Assistance Programs; Other: Survey Administration; Other: Health Promotion and Education

Study type: Interventional

Funder types: Other

Identifiers

NCT07039630

IC-4480925 (Other Identifier)

NCI-2025-03869 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Arm I (enhanced food box, educational materials, call)

Experimental group

Description:

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.

Treatment:

Other: Health Promotion and Education

Other: Survey Administration

Behavioral: Food Assistance Programs

Behavioral: Telephone-Based Intervention

Behavioral: Food Assistance Programs

Other: Questionnaire Administration

Arm II (standard food box)

Active Comparator group

Description:

Participants receive the standard half-price produce box delivery delivered by FreshFix staff over 24 weeks on study.

Treatment:

Other: Survey Administration

Behavioral: Food Assistance Programs

Behavioral: Food Assistance Programs

Other: Questionnaire Administration