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

NCT07039630 — Not applicable, Suspended, 50 participants, Roswell Park Cancer Institute

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A Sustainable Nutrition Security Intervention for Low-Income Households

Registry	NCT07039630
Status	Suspended - behavioral intervention is being prepared
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	50 (Estimated)
Sponsor	Roswell Park Cancer Institute (Other); collaborators: UB Clinical and Translational Science Institute
Conditions	Obesity-Related Malignant Neoplasm
Interventions	Food Assistance Programs, Health Promotion and Education, Questionnaire Administration, Survey Administration, Telephone-Based Intervention (Behavioral, other)
Dates	start 2026-11-15 (estimated), primary completion 2027-05-30 (estimated), completion 2027-05-30 (estimated), first posted 2025-06-26, last updated 2026-09-15
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Arm I (enhanced food box, educational materials, call)	Experimental	Behavioral: Food Assistance Programs; Other: Health Promotion and Education; Other: Questionnaire Administration; Other: Survey Administration; Behavioral: Telephone-Based Intervention	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 (standard food box)	Active comparator	Behavioral: Food Assistance Programs; Other: Questionnaire Administration; Other: Survey Administration	Participants receive the standard half-price produce box delivery delivered by FreshFix staff over 24 weeks on study.

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

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any, 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

+Locations (1)

Facility	City	Country	Status
Roswell Park Cancer Institute	Buffalo, New York	United States

+Investigators

Karen Yeary, Principal investigator, Roswell Park Cancer Institute