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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.
Please see brief summary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enriched GLB | Experimental | 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. |
|
| Standard GLB | Active Comparator | This arm is the standard Group Lifestyle Balance (GLB) program, which is the group version of the Diabetes Prevention Program developed by the NIH. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enriched GLB | Behavioral | Habit formation techniques, namely if-then plans and their mental practice are being added to the standard Group Lifestyle Balance program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent body weight loss | The primary outcome will be percent body weight loss from baseline to 3 months after the beginning of the intervention. Weight in kg. | 3 months after beginning of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Percent body weight loss | Percent body weight loss 12 months after the beginning of the intervention. Weight in kg. | 12 months |
| Percent body weight loss | Percent body weight loss 24 months after the beginning of the intervention. Weight in kg. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Report Index of Habit Strength | Self-monitoring and behaviors | 3 months |
| Self-Report Index of Habit Strength | Self-monitoring and behaviors |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbel Knauper, PhD | McGill University | Principal Investigator |
| Ilka Lowensteyn, PhD | McGill University | Study Director |
| Lawrence Joseph, PhD | McGill University | Study Director |
| Aleksandra Luszczynska, PhD | University of Colorado, Denver | Study Director |
| Steven Grover, MD | McGill University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University | Montreal | Quebec | H3A 1B1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31910891 | Derived | 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. | |
| 29956503 |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D061217 | Weight Reduction Programs |
| ID | Term |
|---|---|
| D006293 | Health Promotion |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
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|
| Standard GLB | Behavioral | This arm is the standard Group Lifestyle Balance program |
|
|
| 24 months |
| Personal weight loss goal | Reaching percent body weight loss goal (7% of body weight) from baseline to 3 months after the beginning of the intervention. Weight in kg. | 3 months |
| Personal weight loss goal | Reaching percent body weight loss goal (7% of body weight) 12 months after the beginning of the intervention. Weight in kg. | 12 months |
| Personal weight loss goal | Reaching percent body weight loss goal (7% of body weight) 24 months after the beginning of the intervention. Weight in kg. | 24 months |
| Personal exercise goal | Reaching exercise goal (150 min/week) from baseline to 3 months after the beginning of the intervention. Sum of minutes over 7 days. | 3 months |
| Personal exercise goal | Reaching exercise goal (150 min/week) 12 months after the beginning of the intervention. Sum of minutes over 7 days. | 12 months |
| Personal exercise goal | Reaching exercise goal (150 min/week) 24 months after the beginning of the intervention. Sum of minutes over 7 days. | 24 months |
| Waist circumference | Risk factor for chronic health problems. | 3 months |
| Waist circumference | Risk factor for chronic health problems. | 12 months |
| Waist circumference | Risk factor for chronic health problems. | 24 months |
| Hemoglobin A1c levels | Risk factor for chronic health problems. | 3 months |
| Hemoglobin A1c levels | Risk factor for chronic health problems. | 12 months |
| Hemoglobin A1c levels | Risk factor for chronic health problems. | 24 months |
| Blood pressure | Risk factor for chronic health problems. | 3 months |
| Blood pressure | Risk factor for chronic health problems. | 12 months |
| Blood pressure | Risk factor for chronic health problems. | 24 months |
| Total cholesterol/HDL ratio | Risk factor for chronic health problems. | 3 months |
| Total cholesterol/HDL ratio | Risk factor for chronic health problems. | 12 months |
| Total cholesterol/HDL ratio | Risk factor for chronic health problems. | 24 months |
| Physical activity duration | Total minutes per week. | 3 months |
| Physical activity duration | Total minutes per week. | 12 months |
| Physical activity duration | Total minutes per week. | 24 months |
| Number of steps taken per week | Steps taken per week, recorded using a pedometer. | 3 months |
| Number of steps taken per week | Steps taken per week, recorded using a pedometer. | 12 months |
| Number of steps taken per week | Steps taken per week, recorded using a pedometer. | 24 months |
| Exercise stress test (EST) | 3 months |
| 12 months |
| Self-Report Index of Habit Strength | Self-monitoring and behaviors | 24 months |
| Habit formation indices of weight tracking | Frequency of weight tracking. | 3 months |
| Habit formation indices of weight tracking | Frequency of weight tracking. | 12 months |
| Habit formation indices of weight tracking | Frequency of weight tracking. | 24 months |
| Habit formation indices of physical activity tracking | Frequency of physical activity tracking. | 3 months |
| Habit formation indices of physical activity tracking | Frequency of physical activity tracking. | 12 months |
| Habit formation indices of physical activity tracking | Frequency of physical activity tracking. | 24 months |
| Habit formation indices of fat grams and calorie tracking | Frequency of food tracking. | 3 months |
| Habit formation indices of fat grams and calorie tracking | Frequency of food tracking. | 12 months |
| Habit formation indices of fat grams and calorie tracking | Frequency of food tracking. | 24 months |
| 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. |
| 24885388 | Derived | 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |
| D005159 |
| Health Care Facilities Workforce and Services |