Food Sequencing in Food Insecurity: The Impact of Food Order/Meal Sequence Counseling Added to Standard Care and a Produce Delivery Program in People With Diabetes/Prediabetes Who Experience Food Insecurity.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in the effect of meal sequencing on Time in Range (TIR) using continuous glucose monitoring (CGM) between baseline and week 24.
研究概览
简要总结
The purpose of this study is study the impact of meal sequencing when added to standard care in individuals with diabetes mellitus/prediabetes who receive produce boxes as part of a food insecurity program.
Meal sequencing is a way of eating where proteins and vegetables are consumed before carbohydrates. Eating proteins and vegetables first has shown to cause lower post meal glucose levels compared to eating carbohydrates first in a meal.
The investigators believe participants with prediabetes or diabetes mellitus experiencing food insecurity enrolled in a produce delivery program and receive meal sequencing counseling will have improvement in glucose levels and dietary quality compared to those who are enrolled in the produce delivery program and receive standard nutritional counseling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nonpregnant adults ages of 18 to 75 with prediabetes or diabetes mellitus who screen positive for food insecurity and provide informed consent.
排除标准
- •Participants with gestational diabetes or pre-existing diabetes in pregnancy.
研究组 & 干预措施
Standard Care Counseling
In this arm, participants who are enrolled in the food insecurity produce delivery program will receive standard care counseling.
干预措施: Standard of Care Counseling (Behavioral)
Food Order/Meal Sequencing
In this arm, participants who are enrolled in the food insecurity produce delivery program will receive food order/meal sequencing counseling alongside standard care counseling.
干预措施: Food Order/Meal Sequencing (Behavioral)
Food Order/Meal Sequencing
In this arm, participants who are enrolled in the food insecurity produce delivery program will receive food order/meal sequencing counseling alongside standard care counseling.
干预措施: Standard of Care Counseling (Behavioral)
结局指标
主要结局
Change in the effect of meal sequencing on Time in Range (TIR) using continuous glucose monitoring (CGM) between baseline and week 24.
时间窗: Baseline, Week 24
Time in range is measured as the percentage of time a participant spends within the target blood glucose range of 70-180mg/dL for participants with diabetes mellitus and 63-140 mg/dL for participants with pre-diabetes. Change in time in range between baseline and week 24 blood glucose range will be assessed.
次要结局
- Change in Dietary Quality Assessed by Healthy Eating Index (HEI)(Baseline and Week 24)
- Change in Dietary Quality Assessed by Alternate Health Eating Index (AHEI)(Baseline and Week 24.)
- Change in HbA1c(Baseline and Week 24.)
- Change in body weight(Baseline and Week 24.)
- Change in FIB4 score(Baseline and Week 24.)
- Change in Total Cholesterol(Baseline and Week 24.)
- Change in low-density lipoprotein cholesterol (LDL)(Baseline and Week 24)
- Change in high-density lipoprotein cholesterol (HDL)(Baseline and Week 24)
- Change in triglycerides(Baseline and Week 24)