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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK142965 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prescription Produce Program (PPP) within a Diabetes Prevention Program (DPP) | Experimental | 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. |
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| Diabetes Prevention Program (DPP) only | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Prevention Program (DPP) | Behavioral | A 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of recruitment rates | Assess feasibility and acceptability by recording and measuring the recruitment rates. | Baseline, 16 weeks, 6 months, and 12 months |
| Assessment of enrollment rates | Assess feasibility and acceptability by recording and measuring the enrollment rates. | Baseline, 16 weeks, 6 months, and 12 months |
| Assessment of attendance | Assess feasibility and acceptability by recording and measuring the attendance rates. | Baseline, 16 weeks, 6 months, and 12 months |
| Assessment of retention rates | Assess feasibility and acceptability by recording and measuring the retention rates. | Baseline, 16 weeks, 6 months, and 12 months |
| Assessment of blood glucose | Blood glucose (hemoglobin A1c) will be recorded and measured to asses the blood glucose levels. | Baseline, 16 weeks, 6 months, and 12 months |
| Assessment of weight | Weight will be will be recorded and measured for assessment | Baseline, 16 weeks, 6 months, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of food security needs | Using the Brief Social Needs evaluation to assess the participants food security needs using the Brief social needs including 2-item food security . | Baseline, 16 weeks, 6 months, and 12 months |
| Assessment of social needs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Diallo | Contact | (804) 852-0538 | dialloa@vcu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ana Diallo | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23298 | United States |
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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.
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| Produce Prescription Plan (PPP) | Behavioral | 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. |
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Using the American Academic of Family Physician Social Needs Screening form to assess the participants social needs. This assessment is a set of validated questions designed to help healthcare providers identify and address social determinants of health. Underlined answers generally indicate a positive response for a social need. For the Personal Safety section, a total numerical value greater than 10 indicates a positive screen. |
| Baseline, 16 weeks, 6 months, and 12 months |
| Assessment of diet quality | Using the Healthy Eating Index derived from DietID™,an assessment tool capturing dietary intake through innovative Diet Quality Photo Navigation (DQPN®) to assess the participants diet quality. The Diet ID scoring system provides a diet quality score on a 1-10 scale. A Diet ID score of 10 represents the highest quality (HEI 90-100), while a score of 1 represents the lowest. | Baseline, 16 weeks, 6 months, and 12 months |
| Assessment of medication adherence | Medication adherence will be recorded and measured for assessment | Baseline, 16 weeks, 6 months, and 12 months |
| Assessment of wellness goals set and met | Wellness goals set and met will be recorded and measured for assessment | Baseline, 16 weeks, 6 months, and 12 months |
| Assessment of physical activity | Physical activity will be recorded and measured for assessment using International Physical Activity Questionnaire (IPAQ) measures time spent sitting, light, moderate, and vigorous activity over a set period (e.g., past 7 days), increased activity time at a higher rate of activity will indicate increased physical activity. | Baseline, 16 weeks, 6 months, and 12 months |
| Assessment of Blood pressure | Both systolic and diastolic blood pressure will be recorded and measured for assessment. | Baseline, 16 weeks, 6 months, and 12 months |