Nutrition Security Intervention for Low-Income Households
This trial is an intervention study for low-income households, aiming to improve nutrition security. It will assess diet quality and intervention acceptability.
Food Assistance Programs
+ Health Promotion and Education
+ Questionnaire Administration
Prevention Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy 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