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Food InsecurityNCT07511699

Produce Prescriptions and Veggie Meter Scores for College Food Security

A study testing Produce boxes in people with Food Insecurity and Carotenoid Status, run by Rutgers, The State University of New Jersey at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this pilot intervention study is to learn if providing weekly produce boxes helps college students who struggle to afford healthy food. It will also test if this program is practical to run on a college campus. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Produce boxes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Sep 2026to 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Must be a currently enrolled student at Rutgers Health.
  • Must be 18 years of age or older.
  • Must be able to pick up a produce box weekly at the designated campus distribution site for 8 consecutive weeks.
  • Must provide informed consent to participate in the study, including all data collection time points (Weeks 0, 4, and 8).

Who cannot join

  • Not a currently enrolled student at Rutgers Health.
  • Less than 18 years of age.
  • Not able to pick up food weekly
  • Not willing to go through study assessments.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Joachim D Sackey, PhD contact

973-972-6245

joachim.sackey@rutgers.edu

United States1 site
  • Rutgers Health Food Pantry

    Newark, New Jersey, 07107

    Joachim Sackey, PhD, 9739726245, joachim.sackey@rutgers.edu

    Joachim D. Sackey, PhD

Other trials in United States

About this study

Official title: Produce Prescriptions and Veggie-Meter Scores: A Feasibility and Pilot Study of an 8-Week Produce Box Intervention to Improve Fruit and Vegetable Intake and Food Security in College Students

The goal of this pilot intervention study is to learn if providing weekly produce boxes helps college students who struggle to afford healthy food. It will also test if this program is practical to run on a college campus. The main questions it aims to answer are:

  • Does receiving free produce boxes increase students' fruit and vegetable intake?
  • Does the program improve students' food security and nutrient levels in the skin? Researchers will measure skin carotenoids (a marker of healthy eating) using a non-invasive finger scan called a Veggie Meter to see if the produce boxes improve nutrition biomarkers.
Read more

Participants will:

  • Receive one free box of fresh fruits and vegetables plus printed nutrition education materials every week for 8 weeks.
  • Visit the campus site at the start, week 4 and end of the study [week 8] for a finger scan, measure their weight and to complete surveys.
  • Provide feedback on their experience with the produce boxes and their food access.
Being tested
Produce boxes
Keywords
Food Insecurity, Produce Prescription, Skin Carotenoids, College Students, Veggie Meter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Produce boxesOther

    The Produce Prescription Program provides a weekly, box of fresh produce specifically curated for high carotenoid content (e.g., leafy greens, carrots, sweet potatoes, and tomatoes). Each box is accompanied by nutrition education materials, including seasonal recipes, storage tips, and preparation guides designed to increase participant food agency and cooking confidence. This intervention is distinguished by its focus on objective nutritional biomarkers; rather than relying solely on self-reported intake, the study utilizes reflection spectroscopy (Veggie Meter) to track changes in skin carotenoid levels at baseline (Week 0), midpoint (Week 4), and completion (Week 8). The contents of the boxes are seasonally dependent to ensure high nutrient density and to simulate a sustainable, real-world campus food-as-medicine model.

Study groups in NCT07511699
Study groupRoleWhat they receive
Produce prescription armExperimentalParticipants receive one produce box per week for 8 consecutive weeks plus printed nutrition information. Each box contains approximately $40 worth of fresh fruits and vegetables selected for their high carotenoid content and dependent on seasonal availability. To monitor biological changes and adherence, participants undergo non-invasive skin carotenoid measurements using a Veggie Meter and complete surveys at baseline (Week 0), midpoint (Week 4), and study completion (Week 8).
Receives: Other: Produce boxes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Skin Carotenoid Score

    Skin carotenoid levels are measured using the Veggie Meter, a non-invasive device that utilizes reflection spectroscopy to provide an objective biomarker of fruit and vegetable intake. The Veggie Meter score is measured on a continuous scale ranging from 0 to 800 units. A higher score indicates a higher concentration of carotenoids in the skin, which serves as a proxy for increased consumption of carotenoid-rich fruits and vegetables. The study will evaluate the change in these scores to determine the impact of the produce box intervention.

    Measured: Baseline (Week 0) and Study Completion (Week 8)

Secondary outcomes (3)
  1. Change in Food Insecurity Status

    Food insecurity is assessed using the 2-item Hunger Vital Sign screener. This validated tool identifies individuals at risk of food insecurity based on concerns about food running out and the inability to afford more food. Responses are categorized as "food secure" or "food insecure." A participant is considered food insecure if they identify as "often true" or "sometimes true" to either of the two statements. The study will evaluate the change in the proportion of participants categorized as food insecure from the beginning to the end of the intervention.

    Measured: Baseline (Week 0) and Study Completion (Week 8)

  2. Change in Self-Reported Daily Fruit and Vegetable Intake

    Fruit and vegetable intake is assessed using the 2-item NIH (National Institutes of Health) All-Day Fruit and Vegetable Screener. This tool asks participants to report the frequency of their consumption of 100% fruit juice and fruit, as well as vegetables (excluding fried potatoes), over the past month. Responses are converted into an estimated score of daily servings of fruits and vegetables. The study will evaluate the mean change in daily servings from baseline to the end of the intervention.

    Measured: Baseline (Week 0) and Study Completion (Week 8)

  3. Change in Prime Diet Quality Score (PDQS)

    Diet quality is assessed using the 21-item Prime Diet Quality Score (PDQS). The PDQS measures the consumption frequency of 21 distinct food groups, which are categorized into 12 "healthy" food groups (e.g., green leafy vegetables, legumes, whole grains) and 9 "unhealthy" food groups (e.g., processed meats, sugar-sweetened beverages, fried foods).

    Scoring logic: > * For healthy food groups, higher consumption frequency receives a higher point value.

    For unhealthy food groups, higher consumption frequency receives a lower point value (points are penalized).

    The total score ranges from 0 to 42, where a higher score indicates better overall diet quality and higher alignment with a nutrient-dense dietary pattern. The study will evaluate the mean change in the total PDQS score from baseline to study completion.

    Measured: Baseline (Week 0) and Study Completion (Week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07511699
Sponsor's protocol ID
Pro2026000603
Status last verified
Apr 2026
First submitted
30 Mar 2026
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: As this is a pilot feasibility study with a small sample size (N=20) at a single campus location, the risk of participant re-identification is elevated. The study team is currently evaluating the technical and ethical requirements for de-identification that would satisfy both Institutional Review Board (IRB) privacy standards and the data sharing requirements of future peer-reviewed journals. A final decision on the scope and platform for data sharing will be made upon the conclusion of the 8-week intervention and primary data analysis.

Publications

  • Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.

    PubMed 25831962
  • Switkowski KM, Kronsteiner-Gicevic S, Rifas-Shiman SL, Lightdale JR, Oken E. Evaluation of the Prime Diet Quality Score from Early Childhood Through Mid-Adolescence. J Nutr. 2024 Jun;154(6):1890-1906. doi: 10.1016/j.tjnut.2024.04.014. Epub 2024 Apr 16.

    PubMed 38614240
  • Hager ER, Quigg AM, Black MM, Coleman SM, Heeren T, Rose-Jacobs R, Cook JT, Ettinger de Cuba SA, Casey PH, Chilton M, Cutts DB, Meyers AF, Frank DA. Development and validity of a 2-item screen to identify families at risk for food insecurity. Pediatrics. 2010 Jul;126(1):e26-32. doi: 10.1542/peds.2009-3146.

    PubMed 20595453
  • Jilcott Pitts S, Moran NE, Laska MN, Wu Q, Harnack L, Moe S, Carr-Manthe P, Gates E, Chang J, Zaidi Y, Gelineau A, Berg L, Craft NE. Reflection Spectroscopy-Assessed Skin Carotenoids Are Sensitive to Change in Carotenoid Intake in a 6-Week Randomized Controlled Feeding Trial in a Racially/Ethnically Diverse Sample. J Nutr. 2023 Apr;153(4):1133-1142. doi: 10.1016/j.tjnut.2023.02.017. Epub 2023 Feb 18.

    PubMed 36804322
  • Radtke MD, Poe M, Stookey J, Jilcott Pitts S, Moran NE, Landry MJ, Rubin LP, Stage VC, Scherr RE. Recommendations for the Use of the Veggie Meter(R) for Spectroscopy-Based Skin Carotenoid Measurements in the Research Setting. Curr Dev Nutr. 2021 Jul 29;5(8):nzab104. doi: 10.1093/cdn/nzab104. eCollection 2021 Aug.

    PubMed 34476333
  • Di Noia J, Gellermann W. Use of the Spectroscopy-Based Veggie Meter(R) to Objectively Assess Fruit and Vegetable Intake in Low-Income Adults. Nutrients. 2021 Jun 30;13(7):2270. doi: 10.3390/nu13072270.

    PubMed 34209048
  • Slagel N, Newman T, Sanville L, Thompson JJ, Dallas J, Cotto-Rivera E, Lee JS. A Pilot Fruit and Vegetable Prescription (FVRx) Program Improves Local Fruit and Vegetable Consumption, Nutrition Knowledge, and Food Purchasing Practices. Health Promot Pract. 2023 Jan;24(1):62-69. doi: 10.1177/15248399211018169. Epub 2021 Jun 2.

    PubMed 34078142
  • Sackey JD, Pike K, Rothpletz-Puglia P, Brody R, Touger-Decker R. Food Insecurity Among Health Sciences Graduate Students at a Large Northeastern University. J Nutr Educ Behav. 2021 May;53(5):428-433. doi: 10.1016/j.jneb.2020.11.003. Epub 2021 Jan 19.

    PubMed 33349595
  • Goldman BJ, Freiria CN, Landry MJ, Arikawa AY, Wright L. Research trends and gaps concerning food insecurity in college students in the United States: a scoping review. J Am Coll Health. 2025 Oct;73(8):2960-2999. doi: 10.1080/07448481.2024.2351420. Epub 2024 Jun 13.

    PubMed 38870038

Questions about this trial

What is this clinical trial studying?

A study testing Produce boxes in people with Food Insecurity and Carotenoid Status, run by Rutgers, The State University of New Jersey at 1 site 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 4 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: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Contact Joachim D Sackey, PhD (973-972-6245, joachim.sackey@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Skin Carotenoid Score (time frame: Baseline (Week 0) and Study Completion (Week 8)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07511699, which also lists 9 linked publications.

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 7 May 2026.

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