Recruiting

Nutrition Security Intervention for Low-Income Households

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Study Aim

This trial is an intervention study for low-income households, aiming to improve nutrition security. It will assess diet quality and intervention acceptability.

What is being tested

Food Assistance Programs

+ Health Promotion and Education

+ Questionnaire Administration

BehavioralOther
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorRoswell Park Cancer Institute
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2025

Actual date on which the first participant was enrolled.

This study aims to create a program to help low-income households have better access to nutritious foods. The goal is to make sure families can consistently get the healthy foods they need, which is known as nutrition security. This is important because having regular access to good nutrition can improve health and well-being. The study will also look at how easy it is to use this program and find out what might help or hinder its success, involving both community organizations and the families themselves. Participants in the study are divided into two groups. One group receives food boxes at a reduced price, delivered by a community health worker, along with help on how to store and handle the food properly. They also get educational materials about nutrition and can use online resources for more learning. A phone call to discuss their diet is made at the start and after six months. The second group receives the same reduced-price food boxes, but they are delivered by the staff of the service provider, FreshFix, over the same 24-week period. The study will track and compare the outcomes of both groups to understand the effectiveness of the program.

Official TitleA Sustainable Nutrition Security Intervention for Low-Income Households 
NCT07039630
Principal SponsorRoswell Park Cancer Institute
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Roswell Park Cancer Institute

Buffalo, United StatesSee the location
Recruiting
One Study Center