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Suspended

NCT Number: NCT07039630

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

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.

Why the study stopped: behavioral intervention is being prepared
Suspended

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Key information

Conditions

Obesity-Related Malignant Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food Assistance Programs

Behavioral

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

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

Primary outcomes

  1. Change in nutrition security

    Time frame: Baseline to 24 weeks

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

  2. Intervention acceptability

    Time frame: At 24 weeks

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

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • UB Clinical and Translational Science Institute

Registry information

Official study title

A Sustainable Nutrition Security Intervention for Low-Income Households

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2025
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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