Integrating a Prescription Produce Program Within a Diabetes Prevention Program
Purpose
Type 2 Diabetes remains a major chronic disease among adults in the United States. A way to prevent Type 2 Diabetes is to engage in a diabetes prevention program. In the diabetes prevention program, individuals at risk of Type 2 Diabetes meet with a health coach to learn effective ways to build health behaviors around diet and physical activity. Individuals who participate in the diabetes prevention program are more likely to lose weight and eat a healthy diet.
Condition
- Type2diabetes
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- ≥age 18 - rationale: adolescents who are at-risk of T2DM may have unique needs that will not be addressed in this study - Most recent BMI ≥ 25kg/m 2 and not pregnant - rationale: elevated BMI is associated with higher risk of developing T2DM - Elevated glucose as evidenced by one of the following criteria: - Hemoglobin A1c 5.7-6.4% indicative of prediabetes within the last 36 months - Fasting blood glucose 100-125mg/dl or 2-hour glucose 140-199mg/dl within the last six months - Physician diagnosis of prediabetes (impaired fasting glucose, impaired glucose intolerance) - These criteria indicate the presence of prediabetes and places individuals are risk of T2DM - Speak, read, and understand English - rationale: current version of PPP intervention (cooking classes) is available in English - Have a working U.S.- based phone number - rationale: participants must have a working phone number because they will receive automated text messages as reminders to receive session reminders; participants must have a working phone number in case adverse event monitoring contacts are required - Able to attend study-related sessions at the Health Hub @ 25th over the year long study (i.e., weekly for 4 months, then monthly for 7 months) - rationale: participants must be able to attend study activities at the community site in order to engage in the intervention and study related sessions.
Exclusion Criteria
- Individuals with HbA1c or glucose levels above the indicated glucose ranges will be advised to see their physician and excluded from participation unless they receive physician consent to participate. - Pregnant adults (>18 years old) will not be included in this current study because prediabetes (HbA1c levels between 5.7% - 6.4% within the last 36 months) during pregnancy presents unique physiological challenges that the study intervention does not address. - Pregnancy status will be based on participants self-report. We will not provide any pregnancy tests prior to enrollment.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- A feasibility and pilot study using a mixed method design with a two-arm parallel active control randomized trial and two focus groups. It is a pragmatic, real-world trial conducted in the community.
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Prescription Produce Program (PPP) within a Diabetes Prevention Program (DPP) |
The research intervention in this study is the DPP + Produce Prescription Plan (DPP+PPP). Besides receiving the DPP, the intervention group participants will receive bags of fresh fruits and vegetables, attend four cooking demonstrations, and if there are positive screens for social needs, be referred to work with a community-based wellness program to access resources. |
|
|
Placebo Comparator Diabetes Prevention Program (DPP) only |
All participants in this research study will participate in the Diabetes Prevention Program (DPP), which is a 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet. Additionally, all participants will be screened for social needs at regular timepoints and receive a list of available resources. |
|
Recruiting Locations
Richmond, Virginia 23298
More Details
- Status
- Recruiting
- Sponsor
- Virginia Commonwealth University
Detailed Description
The diabetes prevention program does not provide support for major factors influencing Type 2 diabetes, such as food insecurity or the challenge of accessing and eating healthy food to maintain optimal health. Millions of adults who are at risk of Type diabetes face challenges such as food insecurity and access to healthcare, transportation, and housing. A prescription produce program is a community-based initiative that supports an individual who may face food insecurity to access healthy fruits and vegetables and receive health advice and resources to manage their health, including referrals for health services, housing, and transportation. This research examines whether or not a diabetes prevention program integrating a prescription produce program provides more benefits in preventing Type 2 diabetes compared to a regular diabetes prevention program. Subjects in this study may lose weight, increase their knowledge of health, and provide additional services to manage their health.