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

NCT07039630 | Suspended

• 2 other identifiers: IC-4480925NCI-2025-03869
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity-Related Malignant Neoplasm

Outcome Measures

Primary Outcomes (2)

• Change in nutrition security

  Diet quality will be assessed by recall interview administered through the Nutrition Data System for Research.

  Baseline to 24 weeks

• Intervention acceptability

  Conducted at 24 week follow up via phone or text based survey

  At 24 weeks

Study Arms (2)

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

EXPERIMENTAL

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.

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

Arm II (standard food box)

ACTIVE COMPARATOR

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

Behavioral: Food Assistance Programs; Other: Questionnaire Administration; Other: Survey Administration

Interventions

Food Assistance Programs BEHAVIORAL

Receive enhanced delivery half-price food boxes delivered by a community health worker

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

Health Promotion and Education OTHER

Receive nutritional education materials and resources

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

Questionnaire Administration OTHER

Ancillary studies

Arm I (enhanced food box, educational materials, call); Arm II (standard food box)

Survey Administration OTHER

Ancillary studies

Arm I (enhanced food box, educational materials, call); Arm II (standard food box)

Telephone-Based Intervention BEHAVIORAL

Receive a dietary recall phone call

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• UB Clinical and Translational Science Institute: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Interventions

Food Assistance; Health Promotion; Educational Status

Intervention Hierarchy (Ancestors)

Public Assistance; Financing, Government; Financing, Organized; Economics; Health Care Economics and Organizations; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Karen Yeary

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 26, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (1)