FreshStart for Health Study

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07815756

Acronym

FS4H

Enrollment

200

Registered

2026-09-11

Start date

2026-07-06

Completion date

2026-12-31

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Insecurity

Keywords

Produce prescription, Food security, Quasi-experimental study

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALProduce prescription

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.

BEHAVIORALNutrition education

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.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Fruit and vegetable intake	Up to 24 weeks.	Participants will complete the short form of the Dietary Screener Questionnaire (10 items) at baseline and post-intervention.
Food security	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

Measure	Time frame	Description
Physical and mental health outcomes	Up to 24 weeks.	Participants will complete a set of validated scales at baseline and after completion of nutrition education classes.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRoger Figueroa, Ph.D., M.P.H., M.Sc.

Cornell University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026