Recruiting

Nutrition Security Intervention for Low-Income Households

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Study AimThis 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

+ Food Assistance Programs
+ Health Promotion and Education
Behavioral
Other
Who is being recruted

Obesity-Related Malignant Neoplasm

Over 18 Years
+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorRoswell Park Cancer Institute
Last updated: September 17, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 30, 2025Actual 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 
Principal SponsorRoswell Park Cancer Institute
Last updated: September 17, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Obesity-Related Malignant Neoplasm
Criteria
5 inclusion criteria required to participate
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

Show More Criteria

3 exclusion criteria prevent from participating
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

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

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

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 InstituteBuffalo, United StatesSee the location
Recruiting
One Study Center