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Cardiometabolic Impact of a Produce Prescription Program in Patients With Type 2 Diabetes and Food Insecurity (GARDEN-CARDIO)

24 giugno 2026 aggiornato da: George Sokos, West Virginia University

A Randomized Crossover Trial Evaluating the Cardiometabolic Impact of a Produce Prescription Program in Patients With Type 2 Diabetes and Food Insecurity

This study is testing whether providing monthly vouchers to buy fruits and vegetables can help improve blood sugar control in adults with type 2 diabetes. People receiving care at WVU clinics who recently had an HbA1c level above 8% will be invited to participate in the study. Those who are interested will speak with a study coordinator, be screened for eligibility, and, if eligible, will provide written consent to join the study. Participants will be randomly assigned to one of two groups. One group will receive $100 per month in produce-only grocery vouchers and standardized dietary education for 5 months, followed by 5 months of usual diabetes care. The second group will receive usual diabetes care first for 5 months, followed by 5 months of produce-only grocery vouchers and standardized dietary education. This crossover design allows all participants to experience both approaches during the study. Researchers will measure changes in blood sugar (HbA1c) as the main outcome. Other outcomes include blood pressure, cholesterol levels, body weight, diet quality, food security, anxiety symptoms, depressive symptoms, and physical activity. These will be assessed through lab tests, clinic measurements, and surveys at certain time points during the 10 month study period. The study team will also track how often participants use the vouchers and any challenges they face. The risks of participating are expected to be minimal and similar to routine diabetes care. The total study duration, including enrollment, participation, and analysis, is expected to be about 18 months.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

88

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • West Virginia
      • Morgantown, West Virginia, Stati Uniti, 26506
        • West Virginia University Heart and Vascular Institute
        • Contatto:
        • Investigatore principale:
          • George Sokos, DO, FACC

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Diagnosis of type 2 diabetes mellitus
  • Most recent HbA1c >8% within the prior 6 months
  • Must have had a clinic visit within the past 6 months
  • Positive screening for food insecurity based on the USDA 6-item food security survey
  • Receiving care through WVU cardiometabolic, endocrinology, or primary care clinics
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • End-stage renal disease
  • Advanced heart failure
  • Severe cognitive impairment
  • Chronic pancreatitis
  • Pancreatic malignancy
  • Pregnancy at time of enrollment
  • Anticipated inability to utilize intervention vouchers (e.g., lack of access to Walmart)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Produce Gift Card to Usual Care
Participants are randomized to receive the produce prescription intervention, consisting of fruit and vegetable vouchers and standardized dietary education, for 5 months, followed by crossover to usual care for an additional 5 months.
Comportamentale: Produce Gift Card and Dietary Education
Participants receive $100 per month in Walmart gift cards restricted to the purchase of fruits and vegetables. Gift cards are provided monthly during the intervention period and usage is tracked using participant-specific access codes. Participants also receive standardized dietary education consistent with current clinical guidelines, delivered by study personnel during the intervention period only.
Altro: Usual Care
Participants receive standard clinical care for management of type 2 diabetes. No study-provided produce vouchers or study-provided dietary education are provided during this period.
Sperimentale: Usual Care to Produce Gift Card
Participants are randomized to receive usual care for 5 months, followed by crossover to the produce prescription intervention, consisting of fruit and vegetable vouchers and standardized dietary education, for an additional 5 months.
Comportamentale: Produce Gift Card and Dietary Education
Participants receive $100 per month in Walmart gift cards restricted to the purchase of fruits and vegetables. Gift cards are provided monthly during the intervention period and usage is tracked using participant-specific access codes. Participants also receive standardized dietary education consistent with current clinical guidelines, delivered by study personnel during the intervention period only.
Altro: Usual Care
Participants receive standard clinical care for management of type 2 diabetes. No study-provided produce vouchers or study-provided dietary education are provided during this period.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Hemoglobin A1c from Baseline to 5 Months
Lasso di tempo: Baseline and 5 months
Change in hemoglobin A1c (%) measured using a standard laboratory test at baseline and at the 5-month study visit. Hemoglobin A1c reflects average blood glucose over the prior 2 to 3 months. The outcome measure is the change in hemoglobin A1c from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 5 months
Change in Hemoglobin A1c from Baseline to 10 Months
Lasso di tempo: Baseline and 10 months
Change in hemoglobin A1c (%) measured using a standard laboratory test at baseline and at the 10-month study visit. Hemoglobin A1c reflects average blood glucose over the prior 2 to 3 months. The outcome measure is the change in hemoglobin A1c from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period
Baseline and 10 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Food Insecurity Score (USDA 6-Item Survey) from Baseline to 5 Months
Lasso di tempo: Baseline and 5 months
Change in food insecurity score measured using the USDA 6-item Food Security Survey at baseline and at the 5 month study visit. Scores range from 0 to 6, with higher scores indicating greater food insecurity. The outcome measure is the change in food insecurity score from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 5 months
Change in Food Insecurity Score (USDA 6-Item Survey) from Baseline to 10 Months
Lasso di tempo: Baseline and 10 months
Change in food insecurity score measured using the USDA 6-item Food Security Survey at baseline and at the 10 month study visit. Scores range from 0 to 6, with higher scores indicating greater food insecurity. The outcome measure is the change in food insecurity score from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 10 months
Change in Sitting Systolic Blood Pressure from Baseline to 5 Months
Lasso di tempo: Baseline and 5 months
Change in sitting systolic blood pressure (mmHg), measured using an automated device at baseline and at the 5 month study visit. Three readings are obtained and averaged at each visit. The outcome measure is the change in systolic blood pressure from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 5 months
Change in Sitting Systolic Blood Pressure from Baseline to 10 Months
Lasso di tempo: Baseline and 10 months
Change in sitting systolic blood pressure (mmHg), measured using an automated device at baseline and at the 10 month study visit. Three readings are obtained and averaged at each visit. The outcome measure is the change in systolic blood pressure from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 10 months
Change in Body Weight from Baseline to 5 Months
Lasso di tempo: Baseline and 5 months
Change in body weight (kg), measured at baseline and at the 5 month study visit. Weight is measured using a calibrated scale. The outcome is the mean change in body weight between baseline and 5 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 5 months
Change in Body Weight from Baseline to 10 Months
Lasso di tempo: Baseline and 10 months
Change in body weight (kg), measured at baseline and at the 10 month study visit. Weight is measured using a calibrated scale. The outcome is the mean change in body weight between baseline and 10 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 10 months
Change in Body Mass Index (BMI) from Baseline to 5 Months
Lasso di tempo: Baseline and 5 months
Change in body mass index (kg/m²), measured at baseline and at the 5 month study visit. BMI is calculated as weight in kilograms divided by height in meters squared using measurements obtained at each visit. The outcome is the mean change in BMI between baseline and 5 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 5 months
Change in Body Mass Index (BMI) from Baseline to 10 Months
Lasso di tempo: Baseline and 10 months
Change in body mass index (kg/m²), measured at baseline and at the 10 month study visit. BMI is calculated as weight in kilograms divided by height in meters squared using measurements obtained at each visit. The outcome is the mean change in BMI between baseline and 10 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 10 months
Change in Waist Circumference from Baseline to 5 Months
Lasso di tempo: Baseline and 5 months
Change in waist circumference (cm), measured at baseline and at the 5 month study visit using a standardized measuring tape. The outcome is the mean change in waist circumference between baseline and 5 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 5 months
Change in Waist Circumference from Baseline to 10 Months
Lasso di tempo: Baseline and 10 months
Change in waist circumference (cm), measured at baseline and at the 10 month study visit using a standardized measuring tape. The outcome is the mean change in waist circumference between baseline and 10 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 10 months
Change in PREVENT Cardiovascular Risk Score from Baseline to 5 Months
Lasso di tempo: Baseline and 5 months
Change in estimated 10-year cardiovascular risk (%) calculated using the American Heart Association PREVENT cardiovascular risk equation at baseline and at the 5-month study visit. Higher values indicate greater cardiovascular risk. The outcome measure is the change in estimated cardiovascular risk from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 5 months
Change in PREVENT Cardiovascular Risk Score from Baseline to 10 Months
Lasso di tempo: Baseline and 10 months
hange in estimated 10-year cardiovascular risk (%) calculated using the American Heart Association PREVENT cardiovascular risk equation at baseline and at the 5-month study visit. Higher values indicate greater cardiovascular risk. The outcome measure is the change in estimated cardiovascular risk from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 10 months
Change in Healthy Eating Index (HEI) Score from Baseline to 5 Months
Lasso di tempo: Baseline and 5 months
The Healthy Eating Index (HEI) score will be measured at baseline and at 5 months using a 24-hour recall of everything the participant ate and drank the previous day, collected by trained study staff. The HEI-2015 scoring method will be used, which compares the participant's diet to national dietary guidelines. The total score ranges from 0 to 100, where higher scores indicate a healthier overall diet. The outcome measure is the change in Healthy Eating Index score from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 5 months
Change in Healthy Eating Index (HEI) Score from Baseline to 10 Months
Lasso di tempo: Baseline and 10 months
The Healthy Eating Index (HEI) score will be measured at baseline and at 10 months using a 24-hour recall of everything the participant ate and drank the previous day, collected by trained study staff. The HEI-2015 scoring method will be used, which compares the participant's diet to national dietary guidelines. The total score ranges from 0 to 100, where higher scores indicate a healthier overall diet. The outcome measure is the change in Healthy Eating Index score from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 10 months
Daily Fruit and Vegetable Intake from Baseline to 5 Months
Lasso di tempo: Baseline and 5 months
Change in mean daily fruit and vegetable intake (cups/day) from baseline and 5 months. Intake is assessed using a 24-hour dietary recall administered by a trained study team member or clinical research coordinator. The outcome measure is the change in average daily fruit and vegetable intake from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 5 months
Daily Fruit and Vegetable Intake from Baseline to 10 Months
Lasso di tempo: Baseline and 10 months
Change in mean daily fruit and vegetable intake (cups/day) from baseline and 10 months. Intake is assessed using a 24-hour dietary recall administered by a trained study team member or clinical research coordinator. The outcome measure is the change in average daily fruit and vegetable intake from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 10 months
Change in Anxiety Score (HADS-A) from Baseline to 5 Months
Lasso di tempo: Baseline and 5 months
Change in anxiety score, measured using the HADS Anxiety subscale (0 to 21) at baseline and at the 5 month study visit. Higher scores indicate greater anxiety symptoms. The outcome measure is the change from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 5 months
Change in Anxiety Score (HADS-A) from Baseline to 10 Months
Lasso di tempo: Baseline and 10 months
Change in anxiety score, measured using the HADS Anxiety subscale (0 to 21) at baseline and at the 10 month study visit. Higher scores indicate greater anxiety symptoms. The outcome measure is the change from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 10 months
Change in Depression Score (HADS-D) from Baseline to 5 Months
Lasso di tempo: Baseline and 5 months
Change in depression score, measured using the HADS Depression subscale (0 to 21) at baseline and at the 5 month study visit. Higher scores indicate greater depressive symptoms. The outcome measure is the change from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 5 months
Change in Depression Score (HADS-D) from Baseline to 10 Months
Lasso di tempo: Baseline and 10 months
Change in depression score, measured using the HADS Depression subscale (0 to 21) at baseline and at the 10 month study visit. Higher scores indicate greater depressive symptoms. The outcome measure is the change from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 10 months
Change in Physical Activity (IPAQ) from Baseline to 5 Months
Lasso di tempo: Baseline and 5 months
Change in physical activity measured using the International Physical Activity Questionnaire (IPAQ), reported as total metabolic equivalent (MET) minutes per week. The IPAQ assesses physical activity over the past 7 days. Measurements are obtained at baseline and at the 5 month study visit. The outcome measure is the change from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 5 months
Change in Physical Activity (IPAQ) from Baseline to 10 Months
Lasso di tempo: Baseline and 10 months
Change in physical activity measured using the International Physical Activity Questionnaire (IPAQ), reported as total metabolic equivalent (MET) minutes per week. The IPAQ assesses physical activity over the past 7 days. Measurements are obtained at baseline and at the 10 month study visit. The outcome measure is the change from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 10 months
Change in Total Cholesterol from Baseline to 5 Months
Lasso di tempo: Baseline and 5 months
Change in total cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 5 month study visit. Total cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in total cholesterol from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 5 months
Change in Total Cholesterol from Baseline to 10 Months
Lasso di tempo: Baseline and 10 months
Change in total cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 10 month study visit. Total cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in total cholesterol from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 10 months
Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 5 Months
Lasso di tempo: Baseline and 5 months
Change in low-density lipoprotein (LDL) cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 5 month study visit. LDL cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in LDL from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 5 months
Change in Low-Density Lipoprotein (LDL) Cholesterol Baseline to 10 months
Lasso di tempo: Baseline and 10 months
Change in low-density lipoprotein (LDL) cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 10 month study visit. LDL cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in LDL from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 10 months
Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 5 Months
Lasso di tempo: Baseline and 5 months
Change in high-density lipoprotein (HDL) cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 5 month study visit. HDL cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in HDL from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 5 months
Change in High-Density Lipoprotein (HDL) Cholesterol Baseline to 10 months
Lasso di tempo: Baseline and 10 months
Change in high-density lipoprotein (HDL) cholesterol (mg/dL), measured via fasting blood sample at baseline and at the 10 month study visit. HDL cholesterol is quantified using standard clinical laboratory methods. The outcome measure is the change in HDL from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 10 months
Change in Triglycerides from Baseline to 5 Months
Lasso di tempo: Baseline and 5 months
Change in triglycerides (mg/dL), measured via fasting blood sample at baseline and at the 5 month study visit. Triglycerides are quantified using standard clinical laboratory methods. The outcome measure is the change in triglycerides from baseline to 5 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 5 months
Change in Triglycerides Baseline to 10 months
Lasso di tempo: Baseline and 10 months
Change in triglycerides (mg/dL), measured via fasting blood sample at baseline and at the 10 month study visit. Triglycerides are quantified using standard clinical laboratory methods. The outcome measure is the change in triglycerides from baseline to 10 months and will be evaluated according to randomized treatment sequence and study period.
Baseline and 10 months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Average Monthly Produce Voucher Spending per Participant
Lasso di tempo: 10 months
Average monthly amount spent (USD) per participant during the produce prescription intervention period, calculated from gift card redemption records.
10 months
Protocol Retention at 5 Months (Proportion of Participants)
Lasso di tempo: 5 months
Proportion of enrolled participants who remain actively enrolled in the study and have not withdrawn consent or been lost to follow-up at the 5-month assessment. Retention is calculated as the number of active participants divided by the total number of enrolled participants.
5 months
Protocol Retention at 10 Months (Proportion of Participants)
Lasso di tempo: 10 months
Proportion of enrolled participants who remain actively enrolled in the study and have not withdrawn consent or been lost to follow-up at the 10-month assessment. Retention is calculated as the number of active participants divided by the total number of enrolled participants.
10 months
Protocol adherence (Proportion of Participants)
Lasso di tempo: 10 months
Proportion of enrolled participants who complete all required study procedures during the 10-month study period, including attendance at scheduled study visits, completion of required laboratory assessments, and completion of required study questionnaires. Adherence is calculated as the number of participants who complete all required study procedures divided by the total number of enrolled participants.
10 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

West Virginia University

Investigatori

  • Investigatore principale: George Sokos, DO, FACC, West Virginia University Heart and Vascular Institute

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 giugno 2027

Date di iscrizione allo studio

Primo inviato

24 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 giugno 2026

Primo Inserito (Effettivo)

30 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY00000327

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Upon reasonable request, prospectively collected data points (lab values, vital signs, survey results) will be shared. All shared data will be completely anonymous.

Periodo di condivisione IPD

Data will be available, upon reasonable request, starting 6 months after the manuscript is published in a scientific peer-reviewed journal. This will be available for other researchers for up to one year.

Criteri di accesso alla condivisione IPD

Criteria include ethical use of data, appropriate citation of source of data (such as study team, grant, etc.), clear plan for use of data, and transparency in use of data. Those requesting access must provide proof of affiliation to United States-based academic institution or clinical facility.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Sponsor e collaboratori

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CROs by country

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
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