Farming for Life - a Program to Prescribe Fresh Organic Vegetables for Adults Living With or at Risk of Type 2 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 303
- 试验地点
- 2
- 主要终点
- Improve cardio-metabolic health in adults with (non-insulin treated) type 2 diabetes or at risk for type 2 diabetes as measured by blood pressure.
研究概览
简要总结
Farming for Life aims to determine the health impacts of providing weekly "prescriptions" of fresh organic vegetables to adults living with or at risk of type 2 diabetes. Over 4 years, up to 400 adults diagnosed with or at high risk of developing type 2 diabetes will be engaged for 3 months each, and receive weekly doses of locally-grown organic vegetable prescriptions. The end-points for comparison will be changes in blood pressure, weight, waist circumference, glycemic control [defined as Time in Range (TIR) (70-140mg/dl)] using continuous glucose monitoring (CGM), and HbA1c levels (a measure of long-term blood glucose level control) after 3 months compared to baseline measurements. Additional assessments will be made on the impact of the organic vegetable prescriptions on food security. At an optional Visit 13, offered 6 months after Visit 1, an additional health screening will be conducted.
Prevalence and risk of type 2 diabetes in the US is disproportionately high among low income and minority groups and is exasperated by high levels of food insecurity. The investigators hypothesize that improving access to fresh organic vegetables will result in measurable health outcomes for adults with type 2 diabetes and those at risk of developing the condition. This represents a promising and potentially cost-effective strategy for improving diabetes outcomes at a population level, particularly among low income, minority populations with type 2 diabetes.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 18 years of age at Visit 1
- •Self-reported diagnosis of type 2 diabetes OR self-reported as at high risk for developing type 2 diabetes
- •Based on program staff's judgment, subject must have a good understanding, ability, and willingness to adhere to the protocol
排除标准
- •Currently taking insulin as treatment for diabetes
- •Any active clinically significant disease or disorder, which in the investigator's opinion could interfere with the participation in the trial
- •Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding comprehension of program activities and informed consent
- •Participation in other trials involving medication or device within 1 month prior to Farming for Life enrollment
- •Known or suspected abuse of alcohol, narcotics, or illicit drugs
结局指标
主要结局
Improve cardio-metabolic health in adults with (non-insulin treated) type 2 diabetes or at risk for type 2 diabetes as measured by blood pressure.
时间窗: 12 weeks
Cardio-metabolic health is described by lower blood pressure (systolic and diastolic pressure, mmHg).
Improve cardio-metabolic health in adults with (non-insulin treated) type 2 diabetes or at risk for type 2 diabetes as measured by body mass index.
时间窗: 12 weeks
Cardio-metabolic health is described by lower body mass index (kg/m2).
Improve cardio-metabolic health in adults with (non-insulin treated) type 2 diabetes or at risk for type 2 diabetes as measured by waist circumference .
时间窗: 12 weeks
Cardio-metabolic health is described by decreased waist circumference (cm).
Improve cardio-metabolic health in adults with (non-insulin treated) type 2 diabetes or at risk for type 2 diabetes as measured by hemoglobin A1c.
时间窗: 12 weeks
Cardio-metabolic health is described by decreased hemoglobin A1c (%).
次要结局
- Improve food security for adults with or at risk for type 2 diabetes assessed by U.S. Household Food Security Survey Module: Six-item short form(Visit 1, Week 1 and Visit 12, Week 12)
- Improve glycemic control measured by continuous glucose monitoring (CGM)(Visit 1, Week 1 to Visit 3, Week 3 and Visit 10, Week 10 to Visit 12, Week 12)
