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

24. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

88

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Spojené státy
    • West Virginia
      • Morgantown, West Virginia, Spojené státy, 26506
        • West Virginia University Heart and Vascular Institute
        • Kontakt:
        • Vrchní vyšetřovatel:
          • George Sokos, DO, FACC

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: 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.
Jiný: 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.
Experimentální: 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.
Behaviorální: 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.
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Hemoglobin A1c from Baseline to 5 Months
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Food Insecurity Score (USDA 6-Item Survey) from Baseline to 5 Months
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Average Monthly Produce Voucher Spending per Participant
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

West Virginia University

Vyšetřovatelé

  • Vrchní vyšetřovatel: George Sokos, DO, FACC, West Virginia University Heart and Vascular Institute

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. června 2027

Dokončení studie (Odhadovaný)

1. června 2027

Termíny zápisu do studia

První předloženo

24. června 2026

První předloženo, které splnilo kritéria kontroly kvality

24. června 2026

První zveřejněno (Aktuální)

30. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

30. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

24. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • STUDY00000327

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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

Časový rámec sdílení 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.

Kritéria přístupu pro sdílení 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.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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