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Clinical Trials/NCT07039630
NCT07039630
Suspended
Not Applicable

A Sustainable Nutrition Security Intervention for Low-Income Households

Roswell Park Cancer Institute1 site in 1 country50 target enrollmentStarted: May 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Suspended
Enrollment
50
Locations
1
Primary Endpoint
Change in nutrition security

Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: Food Assistance Programs (Behavioral)

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.

Intervention: Health Promotion and Education (Other)

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.

Intervention: Questionnaire Administration (Other)

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.

Intervention: Survey Administration (Other)

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.

Intervention: Telephone-Based Intervention (Behavioral)

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.

Intervention: Food Assistance Programs (Behavioral)

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.

Intervention: Questionnaire Administration (Other)

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.

Intervention: Survey Administration (Other)

Outcomes

Primary Outcomes

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.

Intervention acceptability

Time Frame: At 24 weeks

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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