- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07511699
Produce Prescriptions and Veggie Meter Scores for College Food Security
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joachim D Sackey, PhD
- Phone Number: 973-972-6245
- Email: joachim.sackey@rutgers.edu
Study Locations
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New Jersey
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Newark, New Jersey, United States, 07107
- Rutgers Health Food Pantry
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Contact:
- Joachim Sackey, PhD
- Phone Number: 9739726245
- Email: joachim.sackey@rutgers.edu
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Principal Investigator:
- Joachim D. Sackey, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Produce prescription arm
Participants 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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Skin Carotenoid Score
Time Frame: Baseline (Week 0) and Study Completion (Week 8)
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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.
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Baseline (Week 0) and Study Completion (Week 8)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Food Insecurity Status
Time Frame: Baseline (Week 0) and Study Completion (Week 8)
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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.
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Baseline (Week 0) and Study Completion (Week 8)
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Change in Self-Reported Daily Fruit and Vegetable Intake
Time Frame: Baseline (Week 0) and Study Completion (Week 8)
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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.
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Baseline (Week 0) and Study Completion (Week 8)
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Change in Prime Diet Quality Score (PDQS)
Time Frame: Baseline (Week 0) and Study Completion (Week 8)
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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. |
Baseline (Week 0) and Study Completion (Week 8)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Subjective Well-Being (WHO-5)
Time Frame: Baseline (Week 0) and Study Completion (Week 8)
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Subjective well-being and quality of life are assessed using the 5-item World Health Organization Well-Being Index (WHO-5). This validated scale asks participants to rate their well-being over the past two weeks using five positively phrased statements (e.g., "I have felt cheerful and in good spirits"). Scoring logic: > * Each item is scored on a 0 to 5 scale, where 0 is "at no time" and 5 is "all of the time." The raw score ranges from 0 to 25. The raw score is multiplied by 4 to generate a final percentage score from 0 (worst imaginable well-being) to 100 (best imaginable well-being). The study will evaluate the mean change in the transformed (0-100) score from baseline to study completion. |
Baseline (Week 0) and Study Completion (Week 8)
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Collaborators and Investigators
Investigators
- Principal Investigator: Joachim D. Sackey, PhD, Rutgers Health, Rutgers University
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro2026000603
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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