Lowering the Impact of Food Insecurity in African American Adults With Type 2 Diabetes Mellitus (LIFT-DM)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Glycemic control (HbA1c)
研究概览
简要总结
The objective of this protocol is to answer the questions: 1) Within food supplementation options, are mailed stock boxes superior to food vouchers in terms of achieving glycemic control? 2) Is the combination of mailed stock boxes and food vouchers superior to either food supplementation option alone? 3) Does providing diabetes education in combination with food supplementation lead to improved clinical outcomes compared to education alone? To address this gap in the literature, we propose a randomized controlled trial to test the separate and combined efficacy of monthly food vouchers to farmers market and monthly mailed food stock boxes layered upon diabetes education in improving glycemic control in low income, food insecure, AAs with Type 2 Diabetes (T2DM) using a 2x2 factorial design.
详细描述
The overarching aim of this proposal is to conduct a 4-arm RCT to test the separate and combined efficacy of monthly food vouchers to farmers market and monthly mailed food stock boxes layered upon diabetes education in improving glycemic control in low income, food insecure, AAs with T2DM using a 2x2 factorial design. 300 patients will be randomly assigned to four groups of 75 patients each: 1) diabetes education alone; 2) diabetes education plus food vouchers; 3) diabetes education plus mailed stock boxes; and 4) diabetes education plus combined food vouchers and mailed stock boxes. Each patient will be followed for 12 months, with study assessments at baseline, 3, 6, and 12 months. Primary aim is efficacy of separate and combined interventions on HbA1c at 12 months post-randomization. Secondary aims are efficacy of separate and combined interventions on BP, LDL and QOL as well as cost-effectiveness at 12 months post-randomization.
Description of the LIFT-DM Intervention Group 1 - Diabetes Education Only: Individuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation. Twelve 30-minute weekly sessions will be delivered via the telephone, with two 30-minute booster sessions at months 6 and 9.
Group 2 - Diabetes Education Plus Monthly Food Vouchers: Individuals assigned to this group will receive diabetes education and skills training and monthly food vouchers for use at local farmer's markets mailed to their home. Vouchers for $50 will be mailed monthly for 12 months.
Group 3 - Diabetes Education Plus Monthly Stock Boxes: Individuals assigned to this group will receive diabetes education and skills training and monthly stock boxes with diabetes appropriate food items mailed to their home. Stock boxes with foods valued at $50 will be mailed monthly for 12 months.
Group 4 - Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes: Individuals assigned to this group will receive diabetes education and skills training, monthly food vouchers for use at local farmer's markets mailed to their home, and monthly stock boxes with diabetes appropriate food items mailed to their home. Vouchers for $25 and stock boxes with food valued at $25 will be mailed monthly for 12 months. In essence, the combined group will still receive $50 worth of food supplementation monthly as combination of $25 vouchers and $25 mailed stock boxes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >=21 years; 2) self-report as African American/non-Hispanic Black; 3) screen positive for food insecurity over past 12-months using screening questionnaire; 4) clinical diagnosis of type 2 diabetes and HbA1c >=8% at the screening visit; 5) income <=133% of federal poverty level based on household income and size of household or Medicaid eligible; 6) able to communicate in English.
排除标准
- •Mental confusion on interview suggesting significant dementia; 2) Participation in other diabetes clinical trials; 3) Alcohol or drug abuse/dependency; 4) Active psychosis or acute mental disorder; and 5) Life expectancy <12 months.
研究组 & 干预措施
Group 1- Diabetes Education Only
Individuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation.
干预措施: Diabetes Education Only (Behavioral)
Group 2 - Diabetes Education Plus Monthly Food Vouchers
Individuals assigned to this group will receive diabetes education and skills training and monthly food vouchers for use at local Farmer's markets mailed to their home.
干预措施: Diabetes Education Plus Monthly Food Vouchers (Behavioral)
Group 3 - Diabetes Education Plus Monthly Stock Boxes
Individuals assigned to this group will receive diabetes education and skills training and monthly stock boxes with diabetes appropriate food items mailed to their home.
干预措施: Diabetes Education Plus Monthly Stock Boxes (Behavioral)
Group 4 -- Diabetes Education Plus Combination of Monthly Food
Individuals assigned to this group will receive diabetes education and skills training, monthly food vouchers for use at local Farmer's markets mailed to their home, and monthly stock boxes with diabetes appropriate food items mailed to their home.
干预措施: Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes (Behavioral)
结局指标
主要结局
Glycemic control (HbA1c)
时间窗: 12-months post randomization
Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.
次要结局
- LDL-Cholesterol(12-months post randomization)
- Quality of Life as measured by the SF-12(12-months post randomization)
- Blood Pressure(12-months post randomization)
研究者
Leonard Ehianu Egede
Professor & Chair, Department of Medicine
State University of New York at Buffalo