Farming for Life - Health Impact of Organic Vegetable Prescriptions for Adults Living With or at Risk of Type 2 Diabetes

Summary

Participation Requirements

Description

Farming for Life will recruit adults with or at high risk of developing type 2 diabetes (non-insulin treated). Because diabetes rates are disproportionately high in low income and minority populations, the investigators expect that many participants will be members of these groups. After obtaining w...

Farming for Life will recruit adults with or at high risk of developing type 2 diabetes (non-insulin treated). Because diabetes rates are disproportionately high in low income and minority populations, the investigators expect that many participants will be members of these groups. After obtaining written consent, participants will receive 10 weekly free "prescriptions" of fresh organic vegetables sourced from local growers. Health measurements will be conducted by trained clinical staff at baseline and upon completion of the intervention period. The total duration for the program is approximately 4 years, in which up to 400 participants may be engaged. Program visits will take place at vegetable distribution centers and clinical locations (SDRI or other clinical sites). SDRI will ensure provision of appropriately trained clinical staff and equipment to obtain accurate clinical measurements. Potential participants will be recruited via bilingual outreach materials. Up to 440 individuals will be enrolled for an anticipated 400 individuals completing the program (8% anticipated dropout rate). A subset of approximately 120 participants will use CGM. Eligible and consented participants in this program will be asked to complete 12 visits, with an optional 13th visit. Over the course of these visits, participants will collect 10 weekly organic vegetable prescriptions that are signed by a qualified medical practitioner, as well as complete health screenings and questionnaires during the first and last visits. For those using CGM, data will be collected by study staff at an additional Visit 3b, concluding the first 14 days of participation, and at Visit 12, concluding the final 14 days of participation. At each prescription pick-up visit, each participant will receive a week's "dose" of organic vegetables. The outcome data will be collected at Visit 1 after obtaining informed consent and at Visit 12 after the completion of 10 weeks of prescriptions. Additionally, participants will be invited to submit via cell phone, photographs of meals featuring their prescribed organic vegetables. At an optional Visit 13, offered 6 months after Visit 1, an additional health screening will be conducted. Participants may receive nutrition education in the form of printed material featuring organic vegetable recipes and nutrition guidance offered at vegetable collection sites. Recipes will be sourced from the American Diabetes Association Diabetes Food Hub website (www.diabetesfoodhub.org). Aside from the weekly supply of organic vegetables allocated by prescription, health measurements, and printed nutrition education materials, there will be no compensation nor other incentives for program participants. The Unity Shoppe in Santa Barbara (http://www.unityshoppe.org/) hosted Farming for Life in a pilot and will be a storage and distribution site. If necessary, additional appropriately-equipped, Independent Review Board (IRB) approved sites may be used. Visits 1, 12, and 13 will occur at SDRI and, if necessary, additional appropriately-equipped, IRB approved clinical sites. The organic vegetables for this program will primarily be sourced and purchased wholesale from two or more farms within 100 miles of the vegetable distribution location/s. Organic vegetables received for prescription distribution will be coded and tracked through an inventory system. Visit 1 begins with screening and enrollment via the initiation of the informed consent process. Participant eligibility will be confirmed following review of the inclusion and exclusion criteria by program staff. Each participant will be provided with oral and written information (English and/or Spanish, as appropriate) describing the nature and duration of the program. Prior to initiation of program-related procedures, the participant will sign and date the written informed consent and authorization form, authorizing the use and disclosure of the participant's protected health information (PHI). The participant will also sign the California Experimental Subject's Bill of Rights. Once enrolled via informed consent, participants will first complete questionnaires on diabetes management, food security and health. Then participant height, weight, blood pressure and waist circumference will be measured. HbA1c level will be measured via finger-stick. A subset of up to 120 participants will then be trained to wear CGM sensors under supervision of staff. Participants will be informed that the CGM data will be blinded during each CGM session. The CGM data for each participant who may wear a CGM sensor will be summarized using software which produces both a statistical and graphic display of data. Participants will then receive a prescription for 10 weeks of organic vegetables. Finally, participants will be invited to share photographs of and recipes for meals they prepare with their prescribed organic vegetables. Visits 2-11 will all follow the same format and will include the fulfillment of weekly prescriptions. The types and quantities of organic vegetables distributed to each participant will be tracked. For those using CGM, during visit 3 the CGM sensor will be removed, and during visit 10 a CGM sensor will be inserted. During Visit 12, clinical measurements will be taken and recorded as in Visit 1. For those using CGM, the CGM sensor will be removed and data will be downloaded from the recorder. After these measurements, participants will complete questionnaires on diet, food security, and health as they did in Visit 1. Participants will also complete an Exit Questionnaire to gauge satisfaction with and experience participating in the program. At an optional Visit 13, offered 6 months after Visit 1, an additional health screening will be conducted.

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