Yale-Griffin Prevention Research Center| Title: | A Prescription for Health Equity: A Healthcare Provider-based Produce Prescription Program for People with Prediabetes and Type 2 Diabetes |
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| Status: | Current |
| Topic: | Cooking/Culinary Arts;Diabetes / Insulin Resistance |
| Published Article: | Nutrition Education Content for E-Blasts and Websites full.pdf |
| Eligibility: | To qualify for this study, you must: |
| Changed at: | 7/28/2023 3:53 PM | Changed by: | Christian Meagher |
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| Created at: | 7/28/2023 3:48 PM | Created by: | Christian Meagher |
| Title: | Effects of Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern on Endothelial Function, Cardio-Metabolic Risk Factors and Diet Quality |
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| Status: | Current |
| Topic: | Cardiovascular Health / Endothelial Function*;Diabetes / Insulin Resistance;Nutrition / Diet |
| Funding Source: | The Egg Nutrition Center |
| Funding Period: | July 2022 – December 2023 |
| Study Design: | Randomized controlled trial with a crossover design. All participants will be assigned to both an intervention and a control phase. The sequence of the phases will be randomly assigned. |
| Purpose: | This study will examine the effects of including eggs in the context of the Dietary Approach to Stop Hypertension (DASH) diet.The DASH diet features vegetables, fruits, whole grains, low-fat dairy products, fish, poultry, beans, nuts, seeds, and vegetable oils. It includes eggs, but limits egg yolks to 4 per week due to their cholesterol content, and the long-standing belief that foods high in dietary cholesterol raise blood cholesterol level. Yet recent studies haven’t supported a link between dietary and blood cholesterol levels and cardiovascular risk.Because eggs are rich in protein, vitamins, and minerals, and contribute to satiety, it is important to study their consumption in the context of health-promoting diets. |
| Further Study Details: | This study will examine the effects of a DASH diet with and without eggs on cardio-metabolic risk measures and diet quality when consumed by 45 overweight adults with high blood cholesterol. Participants will be randomly assigned to Group A or B. Both groups will receive dietary guidance from the study dietitian.During an initial 4-week run-in period, both groups will consume a DASH diet without eggs.After the first 4 weeks:Group A will consume a DASH diet plus 2 eggs daily for 8 weeks (Phase 1), then a DASH diet without eggs during an 8-week washout, then a DASH diet without eggs for 8 weeks (Phase 2).Group B will consume a DASH diet without eggs for 8 weeks (Phase 1), then a DASH diet without eggs during an 8-week washout, then a DASH diet plus 2 eggs daily for 8-weeks (Phase 2). |
| Eligibility: | Inclusion criteria:Men greater than 18 years of agePost-menopausal women not on hormone replacement therapyNon-smokersOverweight or obeseTotal cholesterol of 240-300 mg/dl and /or LDL cholesterol of 130-190 mg/dl, and/or a total cholesterol to HDL ratio of >5.7 |
| Evaluation: | Assessments will be done at the start and end of each phase. Each of the 4 study assessments will include these measures: 1. Ultrasound of the brachial artery in the right arm to assess blood flow (endothelial function) 2. Review of 3-day diet intake, medications, and physical activity 3. Blood pressure 4. Height, weight, body composition and waist circumference 5. Blood cholesterol, glucose, and insulin |
| Changed at: | 4/12/2023 4:14 PM | Changed by: | Christian Meagher |
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| Created at: | 4/12/2023 4:14 PM | Created by: | Christian Meagher |
| Title: | A Prescription for Health Equity: A Healthcare Provider-based Produce Prescription Program for People with Prediabetes and Type 2 Diabetes |
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| Status: | Current |
| Topic: | Community;Diabetes / Insulin Resistance;Nutrition / Diet |
| Funding Source: | Gus Schumacher Nutrition Incentive Program (GusNIP) Produce Prescription Program, administered by the National Institute of Food and Agriculture at the U.S. Department of Agriculture |
| Funding Period: | 2022-2026 |
| Study Design: | This project will be conducted in 3 phases: 1. Sept. 2022-Feb. 2023: Formative research and program co-design with community partners and potential program participants 2. March 2023-Feb. 2025: Randomized controlled trial of a healthcare provider-based produce prescription program (PPR) 3. March 2025-Aug. 2026: Data analyses and dissemination of findings |
| Purpose: | Griffin Hospital and the Yale-Griffin PRC are partnering to offer a healthcare provider-based produce prescription program (PPR) (co-designed with community partners and residents) to low-income residents of Connecticut’s Lower Naugatuck Valley (LNV) who receive care from Griffin Hospital and/or the Griffin Faculty Physicians practice, and who have prediabetes or type 2 diabetes. The goal is to improve their food security, diet quality, cardio-metabolic health outcomes, and healthcare costs.Disparities in access to healthy foods can lead to disparities in obesity, diabetes, overall health, and quality of life. Produce prescription programs with incentives to buy fruits and vegetables can help improve participants’ food security and nutritional status, which can help reduce health disparities resulting from differential access to healthy foods. |
| Further Study Details: | The project team will recruit 134 adults with pre-diabetes or type 2 diabetes. We will randomly assign 67 to a PPR intervention and 67 to a delayed intervention control group.The 6-month PPR will include vouchers to buy fresh fruits and vegetables, along with nutrition education. The vouchers’ monthly value will be $40 per household, with an extra $5 per additional household member. The specific nutrition education and the voucher redemption sites will be determined based on the formative research. |
| Eligibility: | To qualify for this study, you must be:Age 18 years or olderResident of the Lower Naugatuck ValleyPatient at Griffin Hospital and/or Griffin Faculty Physicians practiceEligible for Medicaid and/or the Supplemental Nutrition Assistance ProgramDiagnosis of prediabetes or type 2 diabetesAble to communicate in English or Spanish |
| Evaluation: | The project team will evaluate the co-design process, PPR implementation, and the PPR’s impact on participants’ food security status, diet quality, hemoglobin A1C, blood lipids, blood pressure, weight, and body mass index. Outcome measures will be assessed at baseline, after the 6-month intervention, and 3 months later. We will also assess the PPR’s impact on healthcare costs. |
| Changed at: | 4/12/2023 1:19 PM | Changed by: | Christian Meagher |
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| Created at: | 4/12/2023 1:19 PM | Created by: | Christian Meagher |
| Title: | COVID-19 Booster Vaccination in Persons with Multiple Sclerosis |
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| Status: | Current |
| Topic: | Multiple Sclerosis;COVID-19 Vaccine |
| Funding Source: | The Connecticut Department of Public Health’s Biomedical Research Trust Fund |
| Funding Period: | 2021-2022 |
| Study Design: | Prospective, randomized study |
| Purpose: | Certain medications prescribed to persons with multiple sclerosis (MS) may suppress their immune systems and reduce the effectiveness of vaccines. This study will test whether adding a booster dose of one of three currently available COVID-19 vaccines to persons with MS on immune-suppressive medications can improve their immune response to COVID-19. Two of the vaccines (Pfizer and Moderna) are mRNA vaccines, while the third (Johnson & Johnson) is a DNA vaccine.This study is designed to:determine immune response by testing for the spike protein antibodies to COVID-19 after receiving a booster of either an mRNA or a DNA vaccine;test whether receiving the same vs. different type of vaccine for a booster – relative to the type of vaccine received initially – is more likely to produce an immune response;test whether certain MS medications are more or less likely to affect response to a booster vaccine;test whether the levels of lymphocytes (T or B cells) and total antibodies affect the likelihood of a response to a booster vaccine. |
| Further Study Details: | Study participants will be randomized to receive a booster dose of either a homologous vaccine or a heterologous vaccine. This means the Johnson & Johnson vaccine if they originally received the Pfizer or Moderna vaccine, or vice versa.At the first visit, participants will provide information on their medication history and course of their MS, undergo a neurological evaluation, have a blood sample taken, and receive a booster vaccination. At the second visit 4 to 6 weeks later, they will respond to questions regarding their booster vaccine experience and state of their MS, and will have a blood sample taken. |
| Eligibility: | We plan to enroll up to 60 adults with MS. They must meet the following criteria:have completed an initial course of one of the three vaccines (Pfizer, Moderna, or Johnson & Johnson);have tested negative for CovID-19 spike protein antibodies after vaccination;are willing to receive one of the three available vaccines as a one-shot booster;women of child-bearing potential must not be pregnant. |
| Evaluation: | Outcome measures include: • percentage of participants who test positive for COVID-19 spike protein antibodies following a booster vaccination; • comparison of percentage of participants who test positive for COVID-19 specific spike protein antibodies between those who receive homologous vs. heterologous boosters. from baseline; • comparison of percentage of participants who test positive for COVID-19 spike protein antibodies based on disease modifying treatment; • correlation of COVID-19 spike antibody presence and levels based on B and T cell subsets and overall immune globulin levels. |
| Changed at: | 12/21/2021 12:54 PM | Changed by: | |
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| Created at: | 12/21/2021 12:44 PM | Created by: |
| Title: | REALIST REVIEW: What Does it Take for Type 2 Diabetes Prevention/Lifestyle Management Virtual Interventions to Work among Low-Income Communities? |
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| Status: | Current |
| Topic: | Community;Diabetes / Insulin Resistance;Health Promotion & Wellness;Nutrition / Diet;Physical Activity |
| Funding Source: | Centers for Disease Control and Prevention (CDC) |
| Funding Period: | 2020-2023 |
| Study Design: | Realist review of published literature |
| Purpose: | Concurrent with our core research project, a team led by Associate Research Scientist Amber Hromi-Fielder, PhD, MPH is conducting a realist review of published research articles on Type 2 diabetes prevention/ lifestyle management interventions in low-income communities. The purpose of this review is to determine how, why and in what circumstances diabetes prevention programs (DPPs) delivered virtually can effectively improve diabetes risk factors among adults with lower incomes. The team will search for articles on: (1) diabetes prevention and lifestyle management programs, (2) virtual services, and (3) community health workers (CHWs), and will then look for areas of overlap between these topics to help address these questions. Adults with lower incomes are at increased risk for Type 2 diabetes, but face barriers to participating in programs to help reduce this risk. Virtual services have been proposed as a way to reduce these barriers. Although they’ve been found effective in improving diabetes self-management among adults in general, less is known about their effectiveness in preventing diabetes in adults with lower incomes.CHWs can serve as a critical link to providing health services to these adults. Research has been published on virtual delivery of DPPs, and the roles of CHWs in diabetes prevention. However, there is a gap in knowledge concerning the role of CHWS in the virtual delivery of DPPs. The realist review is intended to help fill in this gap. |
| Further Study Details: | Realist reviews, unlike traditional systemic reviews, are not intended to locate every published paper. Rather, searches become refined as the conceptual framework guiding the search is continually improved. |
| Eligibility: | Journal articles that meet criteria for selection as established by the Realist Review team. |
| Evaluation: | The team will search for published articles on three research topics and look for areas of overlap between these topics to help address our research questions. See “Purpose” for more details. |
| Changed at: | 4/12/2023 4:17 PM | Changed by: | Christian Meagher |
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| Created at: | 1/5/2021 9:07 AM | Created by: |
| Title: | A Pilot Study of Oral FMT (Fecal Microbial Transplant) in Subjects with Multiple Sclerosis |
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| Status: | Current |
| Topic: | Complementary & Alternative Medicine;Multiple Sclerosis |
| Funding Source: | State of Connecticut: Biomedical Research Trust Fund |
| Funding Period: | 2018-2023 |
| Study Design: | Investigational pilot study |
| Purpose: | This study will examine whether changing the bacteria in the gut through a fecal microbial transplant (FMT) can affect the autoimmune process that leads to the development of multiple sclerosis (MS). Using oral capsules approved by the Food and Drug Administration (FDA) for other uses, we will transfer fecal material from healthy persons to persons with MS. The FDA has granted permission for this investigational pilot study. |
| Further Study Details: | The PRC is conducting this study in collaboration with neurologist Joseph Guarnaccia, MD of the Multiple Sclerosis Treatment Center (MSTC) at Griffin Hospital, who is the principal investigator.Each participant will make 8 visits to Griffin Hospital in Derby, CT. These will include: a clinical screening; a single procedure of 30 FMT capsules taken by mouth; and 5 other visits for blood and stool samples, medical exams, and surveys. FMT capsules and all study procedures and tests will be provided free of charge. |
| Eligibility: | Study participants must: (1) be 18 to 55 years of age; (2) have been clinically diagnosed as having MS; (3) be able to walk with without stopping to rest for up to 100 meters (about 300 feet) or able to walk 20 meters (about 60 feet) without stopping to rest while using 2 canes, 2 crutches, or a walker; (4) not be on immunotherapy (except for interferon beta or glatiramer acetate); and (5) be willing to visit Griffin Hospital 8 times over a 4-month period. |
| Evaluation: | The study team will measure the following: (1) ability to tolerate FMT capsules without vomiting or adverse side effects; (2) changes in immune markers found in blood samples; (3) changes in microbiome of stool samples; (4) changes in self-reported quality of life, mental health status, and levels of fatigue; and (5) changes in MS disease status. |
| Changed at: | 4/12/2023 4:16 PM | Changed by: | Christian Meagher |
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| Created at: | 3/27/2020 2:56 PM | Created by: |
| Title: | CORE RESEARCH PROJECT: Improving Health in Low Income Communities – Virtual Delivery of a Diabetes Prevention Program Facilitated by Community Care Coordination |
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| Status: | Current |
| Topic: | Community;Diabetes / Insulin Resistance;Nutrition / Diet;Physical Activity |
| Funding Source: | Centers for Disease Control and Prevention (CDC) |
| Funding Period: | 2019-2024 |
| Study Design: | Implementation Science Research |
| Purpose: | The risk of diabetes is higher among low-income populations. The progression from pre-diabetes to type 2 diabetes can often be prevented through lifestyle interventions. The Diabetes Prevention Program (DPP) is among the best-studied lifestyle interventions. However, people with low incomes often face barriers to engaging in the DPP when offered in traditional settings. Providing digital online access to the DPP – combined with personally tailored guidance and care coordination – might improve participation, engagement, and outcomes. |
| Further Study Details: | This study will assess the feasibility and health impacts (behavioral and cardio-metabolic outcomes) of implementing a virtually-delivered Diabetes Prevention Program (vDPP) – facilitated by community health workers or hospital-based community nurses –among low-income adults at risk for type 2 diabetes. It will identify and address barriers to participating in evidence-based lifestyle programs. The study will take place in New Haven and the Lower Naugatuck Valley of Connecticut.Specific Aims:Conduct formative research (focus groups, interviews with key stakeholders, and a small pilot study) with community partners to assess community, systemic, technological, and structural level barriers to implementing a v-DPP.In collaboration with community partners, use strategies identified in Aim 1 to maximize impact of the v-DPP in target communities, as evidenced by measures of Reach, Effectiveness, Adoption, Implementation, and Maintenance; and assess factors influencing RE-AIM outcomes, such as social determinants of health, demographic variables, and self-efficacy.Demonstrate improvements in diet quality, physical activity, body weight, and blood pressure, in low-income adults at risk for type 2 diabetes who participate in a v-DPP facilitated by community-based care coordination.Collaborate with community partners to develop and implement a strategic approach to sustain the v-DPP benefits through community-based care coordination in the study communities; and then disseminate the model to other communities. |
| Eligibility: | Adult residents of New Haven and the Lower Naugatuck Valley of CT who are eligible for Medicaid and at risk for type 2 diabetes. |
| Evaluation: | See “Specific Aims” above |
| Changed at: | 12/21/2021 12:48 PM | Changed by: | |
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| Created at: | 3/27/2020 2:52 PM | Created by: |