Skip to main content
OpenTrials
Active, not recruiting

NCT Number: NCT07815756

FreshStart for Health Study

The goal of this study is to test whether a produce prescription program (FS4H) influences health behaviors and food security. FS4H engages a total of 4 cohorts to receive fresh local produce and nutrition lessons.

Active, not recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Food Insecurity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Buffalo Go Green, Buffalo, New York, United States

Loading trial locations.

About this study

This project aims to evaluate the effectiveness and implementation of a produce prescription (PRx) program on health behaviors and food security. The PRx program being evaluated, known as FreshStart for Health (FS4H), offers participants nutrition education lessons and access to fresh local produce (fruits and vegetables) across multiple cohorts, each with varying durations (8, 12, 18, or 24 weeks). FS4H is administered by Buffalo Go Green, serving eligible Kaleida Health employees in Buffalo, New York.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-65 years.
  • Be enrolled in Kaleida's Highmark Blue Cross Blue Shield health plan.
  • Having one of the following:
  • Prediabetes.
  • Diabetes.
  • Prehypertension.
  • Hypertension.
  • Obesity.
  • Food Insecurity.
  • Financial insecurity.

Exclusion criteria

  • Not being enrolled in Kaleida's Highmark Blue Cross Blue Shield health plan.
  • Having no chronic health condition.
  • Being food secure.
  • Having financial stability.

Treatment and study plan

Produce prescription

Behavioral

At random (using a random number generator), participants will be assigned to join a cohort to receive a weekly produce prescription for 8, 12, 18, or 24 weeks. Produce prescriptions can be picked up at a specified location or they can be delivered to participants' home.

Nutrition Education

Behavioral

Participants will attend eight (8), one-hour nutrition education classes. Nutrition education classes will be held primary in-person although a virtual (Zoom) option will be made available if necessary. The classes will be recorded. Nutrition education classes range in topics from eating healthy on a budget to cooking and recipe demonstrations, which entail attending a lecture portion that is combined with hands-on activities during each session.

Primary outcomes

  1. Fruit and vegetable intake

    Time frame: Up to 24 weeks.

    Participants will complete the short form of the Dietary Screener Questionnaire (10 items) at baseline and post-intervention.

  2. Food security

    Time frame: Up to 24 weeks.

    Participants will complete the 6-item USDA Household Food Security Module to assess food security status at baseline and post-intervention.

Secondary outcomes

  1. Physical and mental health outcomes

    Time frame: Up to 24 weeks.

    Participants will complete a set of validated scales at baseline and after completion of nutrition education classes.

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Collaborators

  • Highmark Blue Cross Blue Shield
  • Kaleida Health

Registry information

Official study title

FreshStart for Health: Produce Prescription to Promote Health Behaviors and Food Security.

Acronym: FS4H

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.