FreshStart for Health Study

NCT07815756 | Active Not Recruiting

• 1 other identifier: IRB0149718
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

Food Insecurity

Keywords

Produce prescription; Food security; Quasi-experimental study

Outcome Measures

Primary Outcomes (2)

• Fruit and vegetable intake

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

  Up to 24 weeks.

• Food security

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

  Up to 24 weeks.

Secondary Outcomes (1)

• Physical and mental health outcomes

  Up to 24 weeks.

Study Arms (4)

Weekly produce prescriptions for eight (8) weeks.

EXPERIMENTAL

At random (using a random number generator), participants will be assigned to join a cohort to receive 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. Participants assigned under this arm will receive produce prescriptions up to 8 weeks total.

Behavioral: Produce prescription; Behavioral: Nutrition education

Weekly produce prescriptions for twelve (12) weeks.

EXPERIMENTAL

At random (using a random number generator), participants will be assigned to join a cohort to receive 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. Participants assigned under this arm will receive produce prescriptions up to 12 weeks total.

Behavioral: Produce prescription; Behavioral: Nutrition education

Weekly produce prescriptions for eighteen (18) weeks.

EXPERIMENTAL

At random (using a random number generator), participants will be assigned to join a cohort to receive 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. Participants assigned under this arm will receive produce prescriptions up to 18 weeks total.

Behavioral: Produce prescription; Behavioral: Nutrition education

Weekly produce prescriptions for twenty-four (24) weeks.

EXPERIMENTAL

At random (using a random number generator), participants will be assigned to join a cohort to receive 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. Participants assigned under this arm will receive produce prescriptions up to 24 weeks total.

Behavioral: Produce prescription; Behavioral: Nutrition education

Interventions

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.

Weekly produce prescriptions for eight (8) weeks.; Weekly produce prescriptions for eighteen (18) weeks.; Weekly produce prescriptions for twelve (12) weeks.; Weekly produce prescriptions for twenty-four (24) weeks.

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.

Weekly produce prescriptions for eight (8) weeks.; Weekly produce prescriptions for eighteen (18) weeks.; Weekly produce prescriptions for twelve (12) weeks.; Weekly produce prescriptions for twenty-four (24) weeks.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cornell University: lead
• Kaleida Health: collaborator
• Highmark Blue Cross Blue Shield: collaborator

Study Sites (4)

Kaledia Health

Buffalo, New York, 14209, United States

Location

Buffalo Go Green

Buffalo, New York, 14211, United States

Location

Nutrition Education: Holistic Wellness & Agricultural Education Campus, Buffalo Go Green

Buffalo, New York, 14215, United States

Location

Nutrition Education (Teaching Kitchen Live/Recorded): Buffalo State University, Caudell Hall

Buffalo, New York, 14222, United States

Location

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Roger Figueroa, Ph.D., M.P.H., M.Sc.

  Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: September 11, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)