Pre DiabetesNCT05939349
A Prescription for Health Equity: A Healthcare Provider-based Produce Prescription Program for People With Prediabetes and Type 2 Diabetes
A study testing Produce Prescription Group in people with Pre Diabetes and Diabetes Mellitus, Type 2, run by Griffin Hospital.
Trial summary
The goal of this project is to co-design a healthcare provider-based produce prescription program (PPR) in partnership with the community served to improve participants' food security status, diet quality, and cardio-metabolic health outcomes, and to reduce healthcare costs, specifically related to medication use and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- Produce Prescription Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or older
- a patient of GH and/or GFP
- diagnosis of prediabetes or Type 2 diabetes consistent with the American Diabetes Association diagnostic criteria
- low-income and eligible for SNAP (Supplemental Nutrition Assistance Program, formerly known as Food Stamps) and/or Medicaid.
Who cannot join
- inability to speak English or Spanish
- having had gastric bypass or other bariatric surgeries
- having an eating disorder, or other substantial, clinical dietary restrictions.
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this project is to co-design a healthcare provider-based produce prescription program (PPR) in partnership with the community served to improve participants' food security status, diet quality, and cardio-metabolic health outcomes, and to reduce healthcare costs, specifically related to medication use and hospital visits. Novel to this study is an implementation of a community co-designed randomized controlled trial (RCT) with a delayed intervention control group focused of equity (i.e., including the target population in the intervention designed for them) in design, implementation, and evaluation. The project will be conducted in 3 phases. Phase 1 will involve formative research and PPR co-design with community partners and potential participants through listening sessions, partner meetings, and community advisory group sessions to finalize the intervention protocol and components, for which investigators will then request IRB approval. Phase 2 will involve the implementation of a delayed intervention RCT PPR. Data analysis and final reporting will be conducted during Phase 3.
Specific Aims:
Read more
In collaboration with community partners and community members, utilize implementation science strategies to identify and address community, systemic, and structural barriers and assets to co-design a tailored produce prescription program (PPR) intervention that emphasizes health equity in a low-income population served by Griffin Hospital (GH) and/or Griffin Faculty Physicians (GFP).
Hypothesis: Collaborating with our community partners on the design and implementation of a PPR will lead to a successful design and implementation of the PPR to our population of focus, as evidenced by satisfaction, retention, experiences of dignity/respect, improved self-efficacy related to fruit and vegetable consumption, and diet quality.
Demonstrate improvements, in intervention group vs delayed intervention control group, in food security status, diet quality, and cardio-metabolic outcomes in individuals with prediabetes or type 2 diabetes through implementation of a tailored PPR in a low-income population served by GH and/or GFP.
Hypothesis: The PPR designed with community input will improve food security status, diet quality, self-reported health related quality of life and cardio-metabolic outcomes (Hemoglobin A1C, weight/body mass index, lipids, blood pressure), among our intervention participants compared with a control over a 6-month period.
Evaluate the impact of a tailored PPR on healthcare cost among low-income participants with prediabetes or type 2 diabetes.
Hypothesis: The successful implementation of the tailored PPR will lead to a reduction in certain healthcare cost specifically related to medication usage (including dose) and reduction in emergency department visit and/or hospitalization among intervention participants compared with a control over a 6-month period.
Read the detailed description
The risk of nutrition-related chronic diseases is significantly higher in low-income populations when compared with those with higher incomes. Over the course of the last century, the American diet has shifted toward higher consumption of sugar, saturated fat, added sodium, processed foods, and overall calories, while intake of fresh fruits and vegetables has starkly declined. These dietary shifts parallel the rapid rise in the national prevalence of obesity, cardiovascular disease and type 2 diabetes. With among 1 in 3 adults in the United States currently affected by obesity and over 30 million Americans (1 in 10) with type 2 diabetes, there is a growing need to invest resources in prevention and treatment. Diabetes is considered the seventh leading cause of death and is associated with $327 billion yearly in excess medical costs and lost productivity. Obesity, diabetes rates and diet quality are all associated with socioeconomic status and disparately impact low-income, Black and Hispanic persons compared to their higher-income or white counterparts.
Increasing the consumption of fruits and vegetables can improve health by promoting healthy weight and reducing blood sugar, the risk of heart disease, stroke, some types of cancer, and digestive problems. Studies have shown that even without reducing caloric consumption, increasing fruit and vegetable consumption can provide independent benefits by increasing fiber intake, reducing sodium and fat intake, and increasing the micronutrient content of the consumer's diet. There are grave disparities in access to healthy foods based on income, race, geographic location, and immigration status, which in turn drive disparities in obesity, diabetes, overall health, and quality of life.
Fruit and vegetable incentive programs are a prudent method of improving food security, while not investing in or allocating money for poor nutritional quality food. They guarantee that the money spent goes to fruits and vegetables known to improve nutritional status, and a growing body of evidence demonstrates that money allocated to the purchase of fruits and vegetables can improve diet quality, purchasing patterns and sometimes health in a statistically and clinically significant manner. Produce prescription programs have the potential to reduce health disparities resulting from differential access to healthy food. In addition to providing free or discounted access to produce, many PPRs also attempt to address other cultural and socio-contextual barriers to accessing healthy food by providing educational and skill-building programming such as cooking demonstrations, suggested family meal plans, and nutritional information at the point of purchase. The few studies that examine the effectiveness of PPRs suggest that they are associated with dietary improvements and reductions in food insecurity. Overall, fruit and vegetable incentive programs have demonstrated positive impact (with few studies reporting no impact or minimal impact) on fruit and vegetable intake and or diet quality, reduced hemoglobin A1C, and reduced body weight.
Fruit and vegetable incentive programs are designed to increase the budget share available to a household for the purchase of fruits and vegetables.14 Incentive programs have the ability to immediately increase fruit and vegetable purchases, although the benefits of increasing fruit and vegetable purchases and consumption might take longer to realize. Incentives make it possible to encourage healthier purchasing patterns that are necessary for longer term behavior change that leads to improved health status. According to a 2020 meta-analysis conducted by Engel and Ruder, overall, fruit and vegetable incentive programs have a demonstrated benefit on fruit and vegetable purchase patterns.14 In Connecticut's Lower Naugatuck Valley (LNV), poverty and low-income rates (8% and 21%, respectively, in 2017) have been increasing across the region since 2000, according to a 2019 report on community well-being in the LNV. The seven communities (Ansonia, Beacon Falls, Derby, Naugatuck, Oxford, Seymour, and Shelton) of the LNV have a combined population of approximately 140,000, with increasing racial and ethnic diversity. Food insecurity and nutrition-related chronic disease are significant issues among the area's residents, with 12% of adults reporting food insecurity. Nutrition related chronic diseases such as obesity (affecting 28% of the population) are high. Heart disease and diabetes are among the eight leading causes of premature death and account for an average of 14 and 15 years of potential life lost per disease, respectively.
- Conditions
- Pre Diabetes, Diabetes Mellitus, Type 2
- Being tested
- Produce Prescription Group
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Produce Prescription GroupOther
Participants will receive vouchers equal to $40/household/month, with an additional $5/month per additional household member, for the purchase of fresh fruits and vegetables during the six-month intervention period. The vouchers will be administered in the form of a restricted Mastercard debit card.
A variety of nutrition education options will be offered throughout the intervention period and participation will be tracked. The Nutrition education options will include a periodic newsletter to participants that will include nutrition and diabetes prevention and management opportunities available through Griffin Hospital Population Health Team, the local health department, program and education opportunities available through the Registered Dietitians, local offerings by SNAP-Education and The Expanded Food and Nutrition Education Program.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | The PPR intervention will span 6 months and will include 2 main components: produce vouchers and nutrition education. Receives: Other: Produce Prescription Group |
| Delayed Intervention Group | No intervention | For participants enrolled in the delayed control group they will complete all the biometric measurements and surveys during the 9-month period while the intervention group received the 6-month intervention and completes the 3-month post intervention assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Glycated hemoglobin A1c (HbA1c) will be collected by Griffin's Community Health RN or Yale-Griffin Prevention Research Center Staff (will be obtained by direct measurements from the participants' finger stick blood sample) at baseline, 6 months and 9 months for both groups, while the intervention group is participating in the intervention and while the delayed group. HbA1c will be used to measure the average plasma glucose concentration and will be measured using a finger-prick test.
Measured: Change from Baseline at 6 months and 9 months
Secondary outcomes (10)
Diet quality
Diet quality will be measured using the Global Diet Quality Projects Diet Quality Questionnaire (DQQ) the survey can be found here (https://drive.google.com/drive/folders/16rpv-sr05HXTs3NSZmvFbRaL6dFfcuAs,
Measured: Change from Baseline at 6 months and 9 months
Food Insecurity
Food insecurity will be assessed using the U.S. Department of Agriculture (USDA) household food security survey module 18-item survey modified for a 30 days time reference point instead of the standard past 12-months.27
Measured: Change from Baseline at 6 months and 9 months
Respect and Dignity Scale
This survey, developed with community input from the PRCs CAG and PPR participants in other US projects, will be used to assess participant experiences related to respect and dignity when participating in the various program components.
Measured: Change from Baseline at 6 months and 9 months
Body weight
Body weight will be measured using a calibrated Tanita electronic scale.
Measured: Change from Baseline at 6 months and 9 months
Blood Pressure
Blood pressure will be measured by using a Dinamap Monitor Pro 100 (GE Healthcare, Piscataway, NJ) after sitting for 5 minutes by a registered nurse.
Measured: Change from Baseline at 6 months and 9 months
Serum lipids
Values of total cholesterol (Tchol), triglycerides (TG), and high-density lipoprotein (HDL) will be obtained by direct measurements from the participants' finger stick blood sample. Serum low-density lipoprotein (LDL) will be calculated using the following formula LDL = Tchol - (TG/5 + HDL). HDL:Tchol ratio will also be computed.
Measured: Change from Baseline at 6 months and 9 months
Socio-demographics
Socio-demographics will be measured using standard questionnaires developed by the funder and internally developed items.
Measured: Change from Baseline at 6 months and 9 months
Health related quality of life
Health related quality of life will be measured using a single item consistent with the CDC Behavioral Risk Factor Surveillance System.28 plus additional items collect self-reported diagnosis of nutrition-related nutrition disease.
Measured: Change from Baseline at 6 months and 9 months
Participation in SNAP, food assistance
Participation in SNAP, food assistance will be measured using items standard to the funder,
Measured: Change from Baseline at 6 months and 9 months
Nutrition knowledge
Nutrition knowledge will be measured using an internally developed survey based on the Dietary Guidelines for Americans and MyPlate.
Measured: Change from Baseline at 6 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Pre DiabetesStudies 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
- Parallel groups
- Model description
- The eligible participants will be allocated to one of two arms (i.e., the intervention and delayed intervention groups) and assigned a study number using a SAS-generated random table. The participants will be block randomized in blocks of 4, 6, 8, 10, 12 using a permuted block design in a 1:1 ratio to ensure a balance between the intervention and delayed intervention groups.
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Griffin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Griffin Faculty Physicians, About Fresh
- Responsible party
- Sponsor
- Investigators
- Monica Oris, RN, MSHA, CCM, Study director, Griffin HospitalBeth P Comerford, MS, Study director, Yale-Griffin Prevention Research CenterJaime S Foster, PhD, Principal investigator, Yale-Griffin Prevention Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939349
- Sponsor's protocol ID
- 2022-06
- Status last verified
- Aug 2023
- First submitted
- 19 Apr 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: DMP implementation and fidelity will reside with responsibility will reside with the Assistant Director, Evaluation/Data Director, with reporting to the Project Director and co-Investigators. The Yale-Griffin Prevention Research Center handles all data and data management and plans for all its research studies; the Center has established infrastructure to manage all aspects of the data management plan. The DMP implementation will be included in annual and final reports to NIFA and include progress in data sharing (publications, database, software, curriculum, outreach materials, etc.). The final report will also describe the data produced during the award period and the components that will be stored and preserved.
Publications
Liu J, Rehm CD, Onopa J, Mozaffarian D. Trends in Diet Quality Among Youth in the United States, 1999-2016. JAMA. 2020 Mar 24;323(12):1161-1174. doi: 10.1001/jama.2020.0878.
PubMed 32207798Andreyeva T, Tripp AS, Schwartz MB. Dietary Quality of Americans by Supplemental Nutrition Assistance Program Participation Status: A Systematic Review. Am J Prev Med. 2015 Oct;49(4):594-604. doi: 10.1016/j.amepre.2015.04.035. Epub 2015 Aug 1.
PubMed 26238602Lagisetty PA, Priyadarshini S, Terrell S, Hamati M, Landgraf J, Chopra V, Heisler M. Culturally Targeted Strategies for Diabetes Prevention in Minority Population. Diabetes Educ. 2017 Feb;43(1):54-77. doi: 10.1177/0145721716683811.
PubMed 28118127Teutsch S. The cost-effectiveness of preventing diabetes. Diabetes Care. 2003 Sep;26(9):2693-4. doi: 10.2337/diacare.26.9.2693. No abstract available.
PubMed 12941741American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2017. Diabetes Care. 2018 May;41(5):917-928. doi: 10.2337/dci18-0007. Epub 2018 Mar 22.
PubMed 29567642Beckles GL, Chou CF. Disparities in the Prevalence of Diagnosed Diabetes - United States, 1999-2002 and 2011-2014. MMWR Morb Mortal Wkly Rep. 2016 Nov 18;65(45):1265-1269. doi: 10.15585/mmwr.mm6545a4.
PubMed 27855140Mozaffarian D, Liu J, Sy S, Huang Y, Rehm C, Lee Y, Wilde P, Abrahams-Gessel S, de Souza Veiga Jardim T, Gaziano T, Micha R. Cost-effectiveness of financial incentives and disincentives for improving food purchases and health through the US Supplemental Nutrition Assistance Program (SNAP): A microsimulation study. PLoS Med. 2018 Oct 2;15(10):e1002661. doi: 10.1371/journal.pmed.1002661. eCollection 2018 Oct.
PubMed 30278053Abdullah MM, Gyles CL, Marinangeli CP, Carlberg JG, Jones PJ. Cost-of-illness analysis reveals potential healthcare savings with reductions in type 2 diabetes and cardiovascular disease following recommended intakes of dietary fiber in Canada. Front Pharmacol. 2015 Aug 11;6:167. doi: 10.3389/fphar.2015.00167. eCollection 2015.
PubMed 26321953Dodd AH, Briefel R, Cabili C, Wilson A, Crepinsek MK. Disparities in consumption of sugar-sweetened and other beverages by race/ethnicity and obesity status among United States schoolchildren. J Nutr Educ Behav. 2013 May-Jun;45(3):240-9. doi: 10.1016/j.jneb.2012.11.005. Epub 2013 Feb 13.
PubMed 23414783Bowling AB, Moretti M, Ringelheim K, Tran A, Davison K. Healthy Foods, Healthy Families: combining incentives and exposure interventions at urban farmers' markets to improve nutrition among recipients of US federal food assistance. Health Promot Perspect. 2016 Mar 31;6(1):10-6. doi: 10.15171/hpp.2016.02. eCollection 2016.
PubMed 27123431Cavanagh M, Jurkowski J, Bozlak C, Hastings J, Klein A. Veggie Rx: an outcome evaluation of a healthy food incentive programme. Public Health Nutr. 2017 Oct;20(14):2636-2641. doi: 10.1017/S1368980016002081. Epub 2016 Aug 19.
PubMed 27539192Cooksey-Stowers K, Schwartz MB, Brownell KD. Food Swamps Predict Obesity Rates Better Than Food Deserts in the United States. Int J Environ Res Public Health. 2017 Nov 14;14(11):1366. doi: 10.3390/ijerph14111366.
PubMed 29135909Ghosh-Dastidar B, Cohen D, Hunter G, Zenk SN, Huang C, Beckman R, Dubowitz T. Distance to store, food prices, and obesity in urban food deserts. Am J Prev Med. 2014 Nov;47(5):587-95. doi: 10.1016/j.amepre.2014.07.005. Epub 2014 Sep 10.
PubMed 25217097Engel K, Ruder EH. Fruit and Vegetable Incentive Programs for Supplemental Nutrition Assistance Program (SNAP) Participants: A Scoping Review of Program Structure. Nutrients. 2020 Jun 4;12(6):1676. doi: 10.3390/nu12061676.
PubMed 32512758Bhat S, Coyle DH, Trieu K, Neal B, Mozaffarian D, Marklund M, Wu JHY. Healthy Food Prescription Programs and their Impact on Dietary Behavior and Cardiometabolic Risk Factors: A Systematic Review and Meta-Analysis. Adv Nutr. 2021 Oct 1;12(5):1944-1956. doi: 10.1093/advances/nmab039.
PubMed 33999108
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prescription for Health Equity: A Healthcare Provider-based Produce Prescription Program for People With Prediabetes and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05939349
- Acronym / sponsor ID
- 2022-06
- Conditions
- Pre Diabetes, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Griffin HospitalUniversity, hospital or other
- Collaborators
- Griffin Faculty Physicians, About Fresh
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 11 Jul 2023 (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 project is to co-design a healthcare provider-based produce prescription program (PPR) in partnership with the community served to improve participants' food security status, diet quality, and cardio-metabolic health outcomes, and to reduce healthcare costs, specifically related to medication use and hospital visits. Novel to this study is an implementation of a community co-designed randomized controlled trial (RCT) with a delayed intervention control group focused of equity (i.e., including the target population in the intervention designed for them) in design, implementation, and evaluation. The project will be conducted in 3 phases. Phase 1 will involve formative research and PPR co-design with community partners and potential participants through listening sessions, partner meetings, and community advisory group sessions to finalize the intervention protocol and components, for which investigators will then request IRB approval. Phase 2 will involve the implementation of a delayed intervention RCT PPR. Data analysis and final reporting will be conducted during Phase 3.
Specific Aims:
In collaboration with community partners and community members, utilize implementation science strategies to identify and address community, systemic, and structural barriers and assets to co-design a tailored produce prescription program (PPR) intervention that emphasizes health equity in a low-income population served by Griffin Hospital (GH) and/or Griffin Faculty Physicians (GFP).
Hypothesis: Collaborating with our community partners on the design and implementation of a PPR will lead to a successful design and implementation of the PPR to our population of focus, as evidenced by satisfaction, retention, experiences of dignity/respect, improved self-efficacy related to fruit and vegetable consumption, and diet quality.
Demonstrate improvements, in intervention group vs delayed intervention control group, in food security status, diet quality, and cardio-metabolic outcomes in individuals with prediabetes or type 2 diabetes through implementation of a tailored PPR in a low-income population served by GH and/or GFP.
Hypothesis: The PPR designed with community input will improve food security status, diet quality, self-reported health related quality of life and cardio-metabolic outcomes (Hemoglobin A1C, weight/body mass index, lipids, blood pressure), among our intervention participants compared with a control over a 6-month period.
Evaluate the impact of a tailored PPR on healthcare cost among low-income participants with prediabetes or type 2 diabetes.
Hypothesis: The successful implementation of the tailored PPR will lead to a reduction in certain healthcare cost specifically related to medication usage (including dose) and reduction in emergency department visit and/or hospitalization among intervention participants compared with a control over a 6-month period.
Detailed description
The risk of nutrition-related chronic diseases is significantly higher in low-income populations when compared with those with higher incomes. Over the course of the last century, the American diet has shifted toward higher consumption of sugar, saturated fat, added sodium, processed foods, and overall calories, while intake of fresh fruits and vegetables has starkly declined. These dietary shifts parallel the rapid rise in the national prevalence of obesity, cardiovascular disease and type 2 diabetes. With among 1 in 3 adults in the United States currently affected by obesity and over 30 million Americans (1 in 10) with type 2 diabetes, there is a growing need to invest resources in prevention and treatment. Diabetes is considered the seventh leading cause of death and is associated with $327 billion yearly in excess medical costs and lost productivity. Obesity, diabetes rates and diet quality are all associated with socioeconomic status and disparately impact low-income, Black and Hispanic persons compared to their higher-income or white counterparts.
Increasing the consumption of fruits and vegetables can improve health by promoting healthy weight and reducing blood sugar, the risk of heart disease, stroke, some types of cancer, and digestive problems. Studies have shown that even without reducing caloric consumption, increasing fruit and vegetable consumption can provide independent benefits by increasing fiber intake, reducing sodium and fat intake, and increasing the micronutrient content of the consumer's diet. There are grave disparities in access to healthy foods based on income, race, geographic location, and immigration status, which in turn drive disparities in obesity, diabetes, overall health, and quality of life.
Fruit and vegetable incentive programs are a prudent method of improving food security, while not investing in or allocating money for poor nutritional quality food. They guarantee that the money spent goes to fruits and vegetables known to improve nutritional status, and a growing body of evidence demonstrates that money allocated to the purchase of fruits and vegetables can improve diet quality, purchasing patterns and sometimes health in a statistically and clinically significant manner. Produce prescription programs have the potential to reduce health disparities resulting from differential access to healthy food. In addition to providing free or discounted access to produce, many PPRs also attempt to address other cultural and socio-contextual barriers to accessing healthy food by providing educational and skill-building programming such as cooking demonstrations, suggested family meal plans, and nutritional information at the point of purchase. The few studies that examine the effectiveness of PPRs suggest that they are associated with dietary improvements and reductions in food insecurity. Overall, fruit and vegetable incentive programs have demonstrated positive impact (with few studies reporting no impact or minimal impact) on fruit and vegetable intake and or diet quality, reduced hemoglobin A1C, and reduced body weight.
Fruit and vegetable incentive programs are designed to increase the budget share available to a household for the purchase of fruits and vegetables.14 Incentive programs have the ability to immediately increase fruit and vegetable purchases, although the benefits of increasing fruit and vegetable purchases and consumption might take longer to realize. Incentives make it possible to encourage healthier purchasing patterns that are necessary for longer term behavior change that leads to improved health status. According to a 2020 meta-analysis conducted by Engel and Ruder, overall, fruit and vegetable incentive programs have a demonstrated benefit on fruit and vegetable purchase patterns.14 In Connecticut's Lower Naugatuck Valley (LNV), poverty and low-income rates (8% and 21%, respectively, in 2017) have been increasing across the region since 2000, according to a 2019 report on community well-being in the LNV. The seven communities (Ansonia, Beacon Falls, Derby, Naugatuck, Oxford, Seymour, and Shelton) of the LNV have a combined population of approximately 140,000, with increasing racial and ethnic diversity. Food insecurity and nutrition-related chronic disease are significant issues among the area's residents, with 12% of adults reporting food insecurity. Nutrition related chronic diseases such as obesity (affecting 28% of the population) are high. Heart disease and diabetes are among the eight leading causes of premature death and account for an average of 14 and 15 years of potential life lost per disease, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The eligible participants will be allocated to one of two arms (i.e., the intervention and delayed intervention groups) and assigned a study number using a SAS-generated random table. The participants will be block randomized in blocks of 4, 6, 8, 10, 12 using a permuted block design in a 1:1 ratio to ensure a balance between the intervention and delayed intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Other: Produce Prescription GroupThe PPR intervention will span 6 months and will include 2 main components: produce vouchers and nutrition education. |
| Delayed Intervention Group | No intervention | –For participants enrolled in the delayed control group they will complete all the biometric measurements and surveys during the 9-month period while the intervention group received the 6-month intervention and completes the 3-month post intervention assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older
- a patient of GH and/or GFP
- diagnosis of prediabetes or Type 2 diabetes consistent with the American Diabetes Association diagnostic criteria
- low-income and eligible for SNAP (Supplemental Nutrition Assistance Program, formerly known as Food Stamps) and/or Medicaid.
Key exclusion criteria (3 listed)
- inability to speak English or Spanish
- having had gastric bypass or other bariatric surgeries
- having an eating disorder, or other substantial, clinical dietary restrictions.
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 Prescription GroupParticipants will receive vouchers equal to $40/household/month, with an additional $5/month per additional household member, for the purchase of fresh fruits and vegetables during the six-month intervention period. The vouchers will be administered in the form of a restricted Mastercard debit card. A variety of nutrition education options will be offered throughout the intervention period and participation will be tracked. The Nutrition education options will include a periodic newsletter to participants that will include nutrition and diabetes prevention and management opportunities available through Griffin Hospital Population Health Team, the local health department, program and education opportunities available through the Registered Dietitians, local offerings by SNAP-Education and The Expanded Food and Nutrition Education Program. | Other | Intervention Group |
Primary outcome
Glycemic control
Time frame: Change from Baseline at 6 months and 9 months
Glycated hemoglobin A1c (HbA1c) will be collected by Griffin's Community Health RN or Yale-Griffin Prevention Research Center Staff (will be obtained by direct measurements from the participants' finger stick blood sample) at baseline, 6 months and 9 months for both groups, while the intervention group is participating in the intervention and while the delayed group. HbA1c will be used to measure the average plasma glucose concentration and will be measured using a finger-prick test.
10 secondary outcomes
Diet quality
Time frame: Change from Baseline at 6 months and 9 months
Food Insecurity
Time frame: Change from Baseline at 6 months and 9 months
Respect and Dignity Scale
Time frame: Change from Baseline at 6 months and 9 months
Body weight
Time frame: Change from Baseline at 6 months and 9 months
Blood Pressure
Time frame: Change from Baseline at 6 months and 9 months
Serum lipids
Time frame: Change from Baseline at 6 months and 9 months
Socio-demographics
Time frame: Change from Baseline at 6 months and 9 months
Health related quality of life
Time frame: Change from Baseline at 6 months and 9 months
Participation in SNAP, food assistance
Time frame: Change from Baseline at 6 months and 9 months
Nutrition knowledge
Time frame: Change from Baseline at 6 months and 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 32207798Liu J, Rehm CD, Onopa J, Mozaffarian D. Trends in Diet Quality Among Youth in the United States, 1999-2016. JAMA. 2020 Mar 24;323(12):1161-1174. doi: 10.1001/jama.2020.0878.
- Background: PubMed 26238602Andreyeva T, Tripp AS, Schwartz MB. Dietary Quality of Americans by Supplemental Nutrition Assistance Program Participation Status: A Systematic Review. Am J Prev Med. 2015 Oct;49(4):594-604. doi: 10.1016/j.amepre.2015.04.035. Epub 2015 Aug 1.
- Background: PubMed 28118127Lagisetty PA, Priyadarshini S, Terrell S, Hamati M, Landgraf J, Chopra V, Heisler M. Culturally Targeted Strategies for Diabetes Prevention in Minority Population. Diabetes Educ. 2017 Feb;43(1):54-77. doi: 10.1177/0145721716683811.
- Background: PubMed 12941741Teutsch S. The cost-effectiveness of preventing diabetes. Diabetes Care. 2003 Sep;26(9):2693-4. doi: 10.2337/diacare.26.9.2693. No abstract available.
- Background: PubMed 29567642American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2017. Diabetes Care. 2018 May;41(5):917-928. doi: 10.2337/dci18-0007. Epub 2018 Mar 22.
- Background: PubMed 27855140Beckles GL, Chou CF. Disparities in the Prevalence of Diagnosed Diabetes - United States, 1999-2002 and 2011-2014. MMWR Morb Mortal Wkly Rep. 2016 Nov 18;65(45):1265-1269. doi: 10.15585/mmwr.mm6545a4.
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- Individual participant dataSharing planned: Yes. DMP implementation and fidelity will reside with responsibility will reside with the Assistant Director, Evaluation/Data Director, with reporting to the Project Director and co-Investigators. The Yale-Griffin Prevention Research Center handles all data and data management and plans for all its research studies; the Center has established infrastructure to manage all aspects of the data management plan. The DMP implementation will be included in annual and final reports to NIFA and include progress in data sharing (publications, database, software, curriculum, outreach materials, etc.). The final report will also describe the data produced during the award period and the components that will be stored and preserved.
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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.
Monica Oris, RN, MSHA, CCM study director
Griffin Hospital
Beth P Comerford, MS study director
Yale-Griffin Prevention Research Center
Jaime S Foster, PhD principal investigator
Yale-Griffin Prevention Research Center
Questions about this trial
What is this clinical trial studying?
A study testing Produce Prescription Group in people with Pre Diabetes and Diabetes Mellitus, Type 2, run by Griffin Hospital.
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 3 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rockiy G Ayettey, MS, DHSc (2037321125, rockiy.ayettey@yalegriffinprc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: Change from Baseline at 6 months and 9 months). 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 NCT05939349, which also lists 29 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 14 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.