Food InsecurityFS4HNCT07815756
FreshStart for Health Study
A study testing Produce prescription and Nutrition education in people with Food Insecurity, run by Cornell University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity
- What is being tested?
- Produce prescription and Nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Jul 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years.
- Be enrolled in Kaleida's Highmark Blue Cross Blue Shield health plan.
- Having one of the following:
- Prediabetes.
- Diabetes.
- Prehypertension.
Show all 10Show fewer
- Hypertension.
- Obesity.
- Food Insecurity.
- Financial insecurity.
Who cannot join
- Not being enrolled in Kaleida's Highmark Blue Cross Blue Shield health plan.
- Having no chronic health condition.
- Being food secure.
- Having financial stability.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kaledia Health
Buffalo, New York, 14209
Buffalo Go Green
Buffalo, New York, 14211
Nutrition Education: Holistic Wellness & Agricultural Education Campus, Buffalo Go Green
Buffalo, New York, 14215
Nutrition Education (Teaching Kitchen Live/Recorded): Buffalo State University, Caudell Hall
Buffalo, New York, 14222
About this study
Official title: FreshStart for Health: Produce Prescription to Promote Health Behaviors and Food Security.
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.
Read the 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.
- Conditions
- Food Insecurity
- Being tested
- Produce prescription, Nutrition education
- Keywords
- Produce prescription, Food security, Quasi-experimental study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Produce prescriptionBehavioural
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 educationBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Produce prescription; Behavioral: Nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fruit and vegetable intake
Participants will complete the short form of the Dietary Screener Questionnaire (10 items) at baseline and post-intervention.
Measured: 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.
Measured: Up to 24 weeks.
Secondary outcomes (1)
Physical and mental health outcomes
Participants will complete a set of validated scales at baseline and after completion of nutrition education classes.
Measured: Up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start6 Jul 2026
- Primary completion20 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Kaleida Health, Highmark Blue Cross Blue Shield
- Responsible party
- Sponsor
- Investigators
- Roger Figueroa, Ph.D., M.P.H., M.Sc., Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815756
- Sponsor's protocol ID
- IRB0149718
- Acronym
- FS4H
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FreshStart for Health: Produce Prescription to Promote Health Behaviors and Food Security.
- ClinicalTrials.gov ID
- NCT07815756
- Acronym / sponsor ID
- FS4H / IRB0149718
- Conditions
- Food Insecurity
- Keywords
- Produce prescription, Food security, Quasi-experimental study
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- Kaleida Health, Highmark Blue Cross Blue Shield
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Weekly produce prescriptions for eight (8) weeks. | Experimental | Behavioral: Produce prescription, Behavioral: Nutrition educationAt 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. |
| Weekly produce prescriptions for twelve (12) weeks. | Experimental | Behavioral: Produce prescription, Behavioral: Nutrition educationAt 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. |
| Weekly produce prescriptions for eighteen (18) weeks. | Experimental | Behavioral: Produce prescription, Behavioral: Nutrition educationAt 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. |
| Weekly produce prescriptions for twenty-four (24) weeks. | Experimental | Behavioral: Produce prescription, Behavioral: Nutrition educationAt 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-65 years.
- Be enrolled in Kaleida's Highmark Blue Cross Blue Shield health plan.
- Having one of the following:
- Prediabetes.
- Diabetes.
Key exclusion criteria (4 listed)
- Not being enrolled in Kaleida's Highmark Blue Cross Blue Shield health plan.
- Having no chronic health condition.
- Being food secure.
- Having financial stability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Produce prescriptionAt 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. | Behavioural | 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 educationParticipants 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. | Behavioural | 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. |
Primary outcome
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.
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.
1 secondary outcome
Physical and mental health outcomes
Time frame: Up to 24 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Figueroa, Ph.D., M.P.H., M.Sc. principal investigator
Cornell University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Produce prescription and Nutrition education in people with Food Insecurity, run by Cornell University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fruit and vegetable intake (time frame: Up to 24 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.