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

NCT ID: NCT07039630

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-10-30

Brief Summary

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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

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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.

Conditions

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Obesity-Related Malignant Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

Food Assistance Programs

Intervention Type BEHAVIORAL

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

Health Promotion and Education

Intervention Type OTHER

Receive nutritional education materials and resources

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Telephone-Based Intervention

Intervention Type BEHAVIORAL

Receive a dietary recall phone call

Arm II (standard food box)

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

Group Type ACTIVE_COMPARATOR

Food Assistance Programs

Intervention Type BEHAVIORAL

Receive the standard half-price produce box delivery delivered by FreshFix staff

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Food Assistance Programs

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

Intervention Type BEHAVIORAL

Food Assistance Programs

Receive the standard half-price produce box delivery delivered by FreshFix staff

Intervention Type BEHAVIORAL

Health Promotion and Education

Receive nutritional education materials and resources

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Telephone-Based Intervention

Receive a dietary recall phone call

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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UB Clinical and Translational Science Institute

UNKNOWN

Sponsor Role collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Yeary

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

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Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Karen Yeary

Role: primary

Other Identifiers

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NCI-2025-03869

Identifier Type: REGISTRY

Identifier Source: secondary_id

IC-4480925

Identifier Type: OTHER

Identifier Source: secondary_id

IC-4480925

Identifier Type: -

Identifier Source: org_study_id