Increasing the Effectiveness of the Diabetes Prevention Program Through If-then Plans and Mental Practice: A Parallel Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overweight
- Sponsor
- McGill University
- Enrollment
- 172
- Locations
- 1
- Primary Endpoint
- Percent body weight loss
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
Please see brief summary.
Investigators
Barbel Knauper
Associate Professor
McGill University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Percent body weight loss
Time Frame: 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.
Secondary Outcomes
- 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)