Clinical trial NCT05939349: A Prescription for Health Equity: A Healthcare Provider-based Produce Prescription Program for People With Prediabetes and Type 2 Diabetes
Official title: A Prescription for Health Equity: A Healthcare Provider-based Produce Prescription Program for People With Prediabetes and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pre Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Griffin Hospital
Sponsor class: OTHER
Collaborators: name: Griffin Faculty Physicians
name: About Fresh
First posted: 2023-07-11
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. age 18 years or older
2. a patient of GH and/or GFP
3. diagnosis of prediabetes or Type 2 diabetes consistent with the American Diabetes Association diagnostic criteria
4. low-income and eligible for SNAP (Supplemental Nutrition Assistance Program, formerly known as Food Stamps) and/or Medicaid.

Exclusion Criteria:

1. inability to speak English or Spanish
2. having had gastric bypass or other bariatric surgeries
3. having an eating disorder, or other substantial, clinical dietary restrictions.

Primary outcomes:
measure: Glycemic control
timeFrame: Change from Baseline at 6 months and 9 months
Secondary outcomes:
measure: Diet quality
timeFrame: Change from Baseline at 6 months and 9 months
measure: Food Insecurity
timeFrame: Change from Baseline at 6 months and 9 months
measure: Respect and Dignity Scale
timeFrame: Change from Baseline at 6 months and 9 months
measure: Body weight
timeFrame: Change from Baseline at 6 months and 9 months
measure: Blood Pressure
timeFrame: Change from Baseline at 6 months and 9 months
measure: Serum lipids
timeFrame: Change from Baseline at 6 months and 9 months
measure: Socio-demographics
timeFrame: Change from Baseline at 6 months and 9 months
measure: Health related quality of life
timeFrame: Change from Baseline at 6 months and 9 months
measure: Participation in SNAP, food assistance
timeFrame: Change from Baseline at 6 months and 9 months
measure: Nutrition knowledge
timeFrame: Change from Baseline at 6 months and 9 months
Other outcomes:
measure: Tracking Study Participation Inputs
timeFrame: Change from Baseline at 6 months and 9 months
measure: Medication use
timeFrame: Change from Baseline at 6 months and 9 months
measure: Emergency room visits
timeFrame: Change from Baseline at 6 months and 9 months
measure: Hospitalizations
timeFrame: Change from Baseline at 6 months and 9 months
measure: Field notes
timeFrame: Change from Baseline at 6 months and 9 months
measure: Provider satisfaction survey
timeFrame: 9 months
Locations:
Study officials:
affiliation: Griffin Hospital
name: Monica Oris, RN, MSHA, CCM
role: STUDY_DIRECTOR
affiliation: Yale-Griffin Prevention Research Center
name: Beth P Comerford, MS
role: STUDY_DIRECTOR
affiliation: Yale-Griffin Prevention Research Center
name: Jaime S Foster, PhD
role: PRINCIPAL_INVESTIGATOR
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