Evaluating a Brief Type 2 Diabetes Prevention Program With Greater Scalability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Body Mass Index (BMI) - Post-Test
研究概览
简要总结
This study aims to test the effectiveness of a Type 2 Diabetes (T2D) prevention program for individuals who have been diagnosed with prediabetes compared to a T2D educational control group. Project health is an obesity prevention program and has produced a 42% to 53% reduction in future onset of overweight/obesity and also produced greater reductions in negative affect compared to assessment-only controls that persisted. Project Health has been adapted to prevent onset of T2D among individuals with prediabetes. The study aims to test the effectiveness of Project Health at reducing BMI, HbA1c levels, increase physical activity and improve glucose control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigator and follow-up assessors will be blinded to condition
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18 and 65
- •Overweight (BMI between 25 and 40 kg/m2)
- •Diagnosed with prediabetes, defined as having elevated HbA1c (5.7-6.4%).
排除标准
- •Not between the ages of 18 and 65
- •Not overweight (BMI between 25 and 40 kg/m2)
- •Not diagnosed with prediabetes, defined as having elevated HbA1c (5.7-6.4%).
研究组 & 干预措施
Intervention
Project Health will be delivered in six 1-hour group sessions that will be held weekly. In addition, participants will be asked to complete 30 mins of response inhibition and attention trainings once per week between the sessions. This program promotes to retain the gradual lifestyle modification designed to bring energy intake into balance with energy output and the food response inhibition and attention training, but will adapt the dissonance-induction activities to focus on the negative effects of developing T2D in addition to the negative effects of obesity, overeating, and a sedentary lifestyle.
干预措施: Project Health (Behavioral)
Control
We selected a T2D management psychoeducational comparison condition. To match Project Health, the educational videos will be delivered in 6 1-hour blocks. The educational group will be instructed to watch videos on nutrition, exercise, and how to maintain general health during the lifespan
干预措施: Educational Video Control (Other)
结局指标
主要结局
Body Mass Index (BMI) - Post-Test
时间窗: post-test (immediately after completion of 6 week intervention)
BMI will be assessed at post-test to see which intervention produced greater reductions in BMI
Body Mass Index (BMI) - 3-Month Follow-Up
时间窗: 3-month follow-up
BMI will be assessed at 3-month follow-up to see which intervention produced greater reductions in BMI
HbA1c at 3-month Follow-up
时间窗: 3-month follow-up
Participants will complete an HbA1c test at 3-month follow-up to determine their pre-diabetes status
Fasting Plasma Glucose
时间窗: 3-month follow-up
Participants will complete a fasting glucose test at 3-month follow-up to determine their pre-diabetes status
Percent Body Fat - Post-Test
时间窗: post-test (immediately after completion of 6 week intervention)
Percent Body Fat - 3-Month Follow-Up
时间窗: 3-month follow-up
Percent Lean Body Mass - Post-Test
时间窗: post-test (immediately after completion of 6 week intervention)
Percent Lean Body Mass - 3-Month Follow-Up
时间窗: 3-month follow-up
次要结局
未报告次要终点
研究者
Eric Stice
Professor
Stanford University