Increasing the Effectiveness of the Diabetes Prevention Program Through If-then Plans and Mental Practice: A Parallel Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Percent body weight loss
研究概览
简要总结
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.
详细描述
Please see brief summary.
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
- Single (Participant)
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
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Enriched GLB (Behavioral)
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.
干预措施: Standard GLB (Behavioral)
结局指标
主要结局
Percent body weight loss
时间窗: 3 months after beginning of the intervention
The primary outcome will be percent body weight loss from baseline to 3 months after the beginning of the intervention. Weight in kg.
次要结局
- Exercise stress test (EST)(3 months)
- Personal exercise goal(24 months)
- Total cholesterol/HDL ratio(24 months)
- Number of steps taken per week(24 months)
- Percent body weight loss(24 months)
- Personal weight loss goal(24 months)
- Hemoglobin A1c levels(24 months)
- Physical activity duration(24 months)
- Waist circumference(24 months)
- Blood pressure(24 months)
- Percent body weight loss(12 months)
- Personal weight loss goal(3 months)
- Personal weight loss goal(12 months)
- Personal exercise goal(3 months)
- Personal exercise goal(12 months)
- Waist circumference(3 months)
- Waist circumference(12 months)
- Hemoglobin A1c levels(3 months)
- Hemoglobin A1c levels(12 months)
- Blood pressure(3 months)
- Blood pressure(12 months)
- Total cholesterol/HDL ratio(3 months)
- Total cholesterol/HDL ratio(12 months)
- Physical activity duration(3 months)
- Physical activity duration(12 months)
- Number of steps taken per week(3 months)
- Number of steps taken per week(12 months)
研究者
Barbel Knauper
Associate Professor
McGill University