Increasing the Effectiveness of the Diabetes Prevention Program
2018年3月20日 更新者：Barbel Knauper、McGill University
Increasing the Effectiveness of the Diabetes Prevention Program Through If-then Plans and Mental Practice: A Parallel Randomized Trial
The Diabetes Prevention Program (DPP) is highly effective in promoting weight loss in overweight and obese individuals (e.g., 7% average loss of body weight), and thereby reducing the risk of developing weight-related health consequences.
One-on-one DPP sessions, however, are costly and the group-delivered DPP version, the Group Lifestyle Balance program (GLB), is less effective (4% average loss of body weight).
The aim of this two-arm parallel randomized controlled trial is to increase the effectiveness of the GLB by integrating habit formation techniques, namely if-then plans and their mental practice, into the program.
The study will provide evidence-based data on the effectiveness of an enhanced GLB intervention in promoting weight loss and in reducing weight-related risk factors for chronic health problems.
研究概览
详细说明
Please see brief summary.
研究类型
介入性
注册 (实际的)
172
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Quebec
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Montreal、Quebec、加拿大、H3A 1B1
- McGill University
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- men and women
- ages of 18 and 75
- overweight or obese (BMI 28-45 kg/m2)
- sedentary (< 200 min/week of moderate or vigorous exercise)
- waist circumference of >= 88cm for women and >= 102cm for men
Exclusion Criteria:
- diabetes (hemoglobin A1c < 7.0%).
- taking the medication metformin (used for treating pre-diabetes or diabetes)
- having been pregnant in the past 6 months or planning on becoming pregnant in the next 2 years
- currently undergoing treatment for cancer
- using medication that affects body weight (e.g., loop diuretics)
- being unable to participate in regular moderate physical activity
- having severe uncontrolled hypertension (> 190/100mm Hg)
- being unable to communicate in English or French
- being diagnosed with bulimia nervosa, currently active major depression, or other severe psychiatric disease (including dementia);
- suffering from a heart attack, stroke, or heart failure within the past 6 months
- experiencing excessive weight loss (more than 10 pounds or 4.54 kilograms) in the past 3 months
- currently participating in another weight loss program
- having had bariatric surgery in the past 2 years or plans on getting it in the near future
- planning on moving away from Montreal within the next year
- having another member of one's household enrolled in the program.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Enriched GLB
This arm aims to increase the effectiveness of the Group Lifestyle Balance (GLB) program by integrating habit formation techniques, namely if-then plans and their mental practice, into the program.
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Habit formation techniques, namely if-then plans and their mental practice are being added to the standard Group Lifestyle Balance program.
其他名称：
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有源比较器：Standard GLB
This arm is the standard Group Lifestyle Balance (GLB) program, which is the group version of the Diabetes Prevention Program developed by the NIH.
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This arm is the standard Group Lifestyle Balance program
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percent body weight loss
大体时间：3 months after beginning of the intervention
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The primary outcome will be percent body weight loss from baseline to 3 months after the beginning of the intervention.
Weight in kg.
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3 months after beginning of the intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percent body weight loss
大体时间：12 months
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Percent body weight loss 12 months after the beginning of the intervention.
Weight in kg.
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12 months
|
|
Percent body weight loss
大体时间：24 months
|
Percent body weight loss 24 months after the beginning of the intervention.
Weight in kg.
|
24 months
|
|
Personal weight loss goal
大体时间：3 months
|
Reaching percent body weight loss goal (7% of body weight) from baseline to 3 months after the beginning of the intervention.
Weight in kg.
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3 months
|
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Personal weight loss goal
大体时间：12 months
|
Reaching percent body weight loss goal (7% of body weight) 12 months after the beginning of the intervention.
Weight in kg.
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12 months
|
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Personal weight loss goal
大体时间：24 months
|
Reaching percent body weight loss goal (7% of body weight) 24 months after the beginning of the intervention.
Weight in kg.
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24 months
|
|
Personal exercise goal
大体时间：3 months
|
Reaching exercise goal (150 min/week) from baseline to 3 months after the beginning of the intervention.
Sum of minutes over 7 days.
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3 months
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Personal exercise goal
大体时间：12 months
|
Reaching exercise goal (150 min/week) 12 months after the beginning of the intervention.
Sum of minutes over 7 days.
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12 months
|
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Personal exercise goal
大体时间：24 months
|
Reaching exercise goal (150 min/week) 24 months after the beginning of the intervention.
Sum of minutes over 7 days.
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24 months
|
|
Waist circumference
大体时间：3 months
|
Risk factor for chronic health problems.
|
3 months
|
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Waist circumference
大体时间：12 months
|
Risk factor for chronic health problems.
|
12 months
|
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Waist circumference
大体时间：24 months
|
Risk factor for chronic health problems.
|
24 months
|
|
Hemoglobin A1c levels
大体时间：3 months
|
Risk factor for chronic health problems.
|
3 months
|
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Hemoglobin A1c levels
大体时间：12 months
|
Risk factor for chronic health problems.
|
12 months
|
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Hemoglobin A1c levels
大体时间：24 months
|
Risk factor for chronic health problems.
|
24 months
|
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Blood pressure
大体时间：3 months
|
Risk factor for chronic health problems.
|
3 months
|
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Blood pressure
大体时间：12 months
|
Risk factor for chronic health problems.
|
12 months
|
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Blood pressure
大体时间：24 months
|
Risk factor for chronic health problems.
|
24 months
|
|
Total cholesterol/HDL ratio
大体时间：3 months
|
Risk factor for chronic health problems.
|
3 months
|
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Total cholesterol/HDL ratio
大体时间：12 months
|
Risk factor for chronic health problems.
|
12 months
|
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Total cholesterol/HDL ratio
大体时间：24 months
|
Risk factor for chronic health problems.
|
24 months
|
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Physical activity duration
大体时间：3 months
|
Total minutes per week.
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3 months
|
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Physical activity duration
大体时间：12 months
|
Total minutes per week.
|
12 months
|
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Physical activity duration
大体时间：24 months
|
Total minutes per week.
|
24 months
|
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Number of steps taken per week
大体时间：3 months
|
Steps taken per week, recorded using a pedometer.
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3 months
|
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Number of steps taken per week
大体时间：12 months
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Steps taken per week, recorded using a pedometer.
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12 months
|
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Number of steps taken per week
大体时间：24 months
|
Steps taken per week, recorded using a pedometer.
|
24 months
|
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Exercise stress test (EST)
大体时间：3 months
|
3 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Self-Report Index of Habit Strength
大体时间：3 months
|
Self-monitoring and behaviors
|
3 months
|
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Self-Report Index of Habit Strength
大体时间：12 months
|
Self-monitoring and behaviors
|
12 months
|
|
Self-Report Index of Habit Strength
大体时间：24 months
|
Self-monitoring and behaviors
|
24 months
|
|
Habit formation indices of weight tracking
大体时间：3 months
|
Frequency of weight tracking.
|
3 months
|
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Habit formation indices of weight tracking
大体时间：12 months
|
Frequency of weight tracking.
|
12 months
|
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Habit formation indices of weight tracking
大体时间：24 months
|
Frequency of weight tracking.
|
24 months
|
|
Habit formation indices of physical activity tracking
大体时间：3 months
|
Frequency of physical activity tracking.
|
3 months
|
|
Habit formation indices of physical activity tracking
大体时间：12 months
|
Frequency of physical activity tracking.
|
12 months
|
|
Habit formation indices of physical activity tracking
大体时间：24 months
|
Frequency of physical activity tracking.
|
24 months
|
|
Habit formation indices of fat grams and calorie tracking
大体时间：3 months
|
Frequency of food tracking.
|
3 months
|
|
Habit formation indices of fat grams and calorie tracking
大体时间：12 months
|
Frequency of food tracking.
|
12 months
|
|
Habit formation indices of fat grams and calorie tracking
大体时间：24 months
|
Frequency of food tracking.
|
24 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Ilka Lowensteyn, PhD、McGill University
- 研究主任：Lawrence Joseph, PhD、McGill University
- 研究主任：Aleksandra Luszczynska, PhD、University of Colorado, Denver
- 研究主任：Steven Grover, MD、McGill University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Knauper B, Shireen H, Carriere K, Frayn M, Ivanova E, Xu Z, Lowensteyn I, Sadikaj G, Luszczynska A, Grover S; McGill CHIP Healthy Weight Program Investigators. The effects of if-then plans on weight loss: results of the 24-month follow-up of the McGill CHIP Healthy Weight Program randomized controlled trial. Trials. 2020 Jan 7;21(1):40. doi: 10.1186/s13063-019-4014-z.
- Knauper B, Carriere K, Frayn M, Ivanova E, Xu Z, Ames-Bull A, Islam F, Lowensteyn I, Sadikaj G, Luszczynska A, Grover S; McGill CHIP Healthy Weight Program Investigators. The Effects of If-Then Plans on Weight Loss: Results of the McGill CHIP Healthy Weight Program Randomized Controlled Trial. Obesity (Silver Spring). 2018 Aug;26(8):1285-1295. doi: 10.1002/oby.22226. Epub 2018 Jun 28.
- Knauper B, Ivanova E, Xu Z, Chamandy M, Lowensteyn I, Joseph L, Luszczynska A, Grover S. Increasing the effectiveness of the Diabetes Prevention Program through if-then plans: study protocol for the randomized controlled trial of the McGill CHIP Healthy Weight Program. BMC Public Health. 2014 May 18;14:470. doi: 10.1186/1471-2458-14-470.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年4月1日
初级完成 (实际的)
2017年12月1日
研究完成 (实际的)
2017年12月1日
研究注册日期
首次提交
2013年12月6日
首先提交符合 QC 标准的
2013年12月6日
首次发布 (估计)
2013年12月11日
研究记录更新
最后更新发布 (实际的)
2018年3月21日
上次提交的符合 QC 标准的更新
2018年3月20日
最后验证
2018年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.