Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this study is to understand how a Produce Prescription Program paired with a behavioral nutrition intervention affect nutrition and overall health in low-income Iowans with type 2 diabetes or pre-diabetes. Research questions include:
Participants of the behavioral nutrition intervention (Produce Your Path) alone will:
Participants of both the Produce Prescription and Produce Your Path Interventions will:
Participants of the control group will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-PPP+PYP Group | Experimental | The I-PPP+PYP participants will participate in both the Iowa Produce Prescription Program and the Produce Your Path Behavioral Nutrition Intervention. This group will complete the monthly PYP intervention modules to receive the produce prescription dollar amount, which can be redeemed at partnering retail locations on fresh fruits and vegetables. An optional Facebook group for the I-PPP+PYP participants with offer additional social support and resources for participants, who can use the Facebook page to post questions, share goals and recipes, and answer prompts posted by the research team. |
|
| PYP Alone Group | Experimental | The PYP Alone Group will complete the six-month behavioral nutrition intervention, but will not receive monthly incentives to redeem for fresh fruits and vegetables. PYP Alone participants will still complete the corresponding quizzes to monthly education modules. The PYP Alone participants will also have access to separate optional Facebook group to post questions, share goals and recipes, and answer prompts posted by the research team. |
|
| Control Group | No Intervention | This group will not receive the produce prescription incentive or behavioral intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iowa Produce Prescription Program (I-PPP) | Other | The I-PPP intervention offers a produce prescription in the form of $30.00 per family member in a household every month to spend on fruit and vegetables. The dollars can be used at local retail partners, which are specific to each community. A mobile app has been developed for the I-PPP intervention participants. At the beginning of each month for six months, the app asks participants to complete a nutrition education module and a corresponding short quiz. After the participant completes the module, $30.00 per family member in the house will be loaded into the app for participants to use over the next month at local retail partners to buy fresh fruits and vegetables. Participants will have 30 days from the date of distribution to spend the funds before they expire. |
| Measure | Description | Time Frame |
|---|---|---|
| Nutrition Security | The USDA's definition of Nutrition Security is 'all Americans have consistent and equitable access to healthy, safe, affordable foods essential to optimal health and well-being'. To measure participant's nutrition security, the investigators will administer the four-item Household Nutrition Security tool developed by the Center for Nutrition & Health Impact. Participants of every arm of the study will complete the nutrition security items as part of the Baseline Survey (Month 1) and Post-Survey (Month 6). Participants will answer the four questions using a 5-point Likert frequency scale (never to always). The answers correspond to a number, and the overall score is the mean of the four answers, with lower scores indicating less nutrition security. | From Month 1 of the intervention to the end of the intervention (Month 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HA1c) | Participant's hemoglobin A1c levels (HA1c) will be measured to help identify how well blood sugar levels are being managed. The Hemoglobin A1c test measures what percentage of blood hemoglobin proteins are glycated, with higher percentages indicating poorer glucose control and prediabetes or diabetes. This test is conducted by participant's primary care providers and data is released to the research team. HA1c will be collected from lab draws in electronic medical records. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | BMI from height and weight will be collected near the beginning and conclusion of the intervention by the primary care provider. | From Month 1 of the intervention to the end of the intervention (Month 6) |
| Food Security |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iowa State University | Ames | Iowa | 50014 | United States |
Not provided
| Label | URL |
|---|---|
| Iowa Healthiest State Initiative's Iowa Produce Rx webpage. | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Produce Your Path Behavioral Nutrition Intervention (PYP) | Behavioral | The PYP Intervention is a six-month virtual behavioral intervention grounded in Self Determination Theory. The intervention aims to improve participants' competence, autonomy, and sense of relatedness through educational videos, recipes, and supplemental resources. Each monthly module contains several short videos, totaling around 15 minutes in length. The module topics include goal-setting, planning meals, preparing fruits and vegetables, reading nutrition labels, budgeting for healthier eating, and making healthier food swaps. The videos are tailored to represent a variety of cultures, ethnicities, and backgrounds, with diverse actors and recipes. Upon completion of each monthly module, a short quiz is administered to participants to measure self-efficacy related to the topic and prompt goal-setting. To further increase social support, an optional Facebook Group component allows participants to post questions, share goals and recipes, and answer prompts from the research team. |
|
| From Month 1 of the intervention to the end of the intervention (Month 6) |
| Dietary Intake | Investigators will measure participant's fruit and vegetable consumption using the 10-item dietary assessment tool from the Center for Nutrition, which was previously adapted from the Dietary Screener Questionnaire from developed by NIH and the National Cancer Insititute. The assessment tool asks participants how often they consumed certain fruits, vegetables, and food products over the last 30 days. This dietary assessment tool is part of the Baseline Survey (Month 1) and Post-Survey (Month 6). | From Month 1 of the intervention to the end of the intervention (Month 6) |
| Psychosocial Mediators | Psychosocial constructs including self-efficacy, social support, and motivation level are measured in the Baseline Survey (Month 1) and Post-Survey (Month 6). Self-efficacy and social support are measured using a two- and three-item tool recommended by the Center for Nutrition, respectively. Motivational level is measured using the 15-item Treatment Self-Regulation Questionnaire, which was specifically developed to measure how intrinsically motivated a person is, as proposed by Self Determination Theory. These psychosocial constructs were chosen because the intervention is designed to increase self-efficacy and social support, and is also grounded in Self Determination Theory, aiming to increase intrinsic motivation. | From Month 1 of the intervention to the end of the intervention (Month 6) |
Food Security will be measured using the 6-item shortened version of the USDA's household food security tool, as recommended by the Center for Nutrition. Food security is defined as 'access by all people at all times to enough food for an active, healthy life.'
| From Month 1 of the intervention to the end of the intervention (Month 6) |
| Lipid Panel | Participant's serum lipids (Total cholesterol, HDL, LDL, and triglycerides) will be collected near the beginning and conclusion of the intervention by the primary care provider. | From Month 1 of the intervention to the end of the intervention (Month 6) |
| Blood Pressure | The primary care provider will collect blood pressure near the beginning and conclusion of the intervention. | From Month 1 of the intervention to the end of the intervention (Month 6) |
| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |