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Increasing the Effectiveness of the Diabetes Prevention Program

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Enriched GLB
Standard GLB
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Group-delivered Diabetes Prevention Program, Obesity, Overweight, Lifestyle change, Healthy eating, Weight loss, Exercise, Cognitive-behavioral intervention, Implementation intentions, Mental imagery, Mental practice, If-then plans

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McGill University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enriched GLB

Standard GLB

Arm Description

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.

This arm is the standard Group Lifestyle Balance (GLB) program, which is the group version of the Diabetes Prevention Program developed by the NIH.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent body weight loss
Percent body weight loss 12 months after the beginning of the intervention. Weight in kg.
Percent body weight loss
Percent body weight loss 24 months after the beginning of the intervention. Weight in kg.
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.
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.
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.
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.
Personal exercise goal
Reaching exercise goal (150 min/week) 12 months after the beginning of the intervention. Sum of minutes over 7 days.
Personal exercise goal
Reaching exercise goal (150 min/week) 24 months after the beginning of the intervention. Sum of minutes over 7 days.
Waist circumference
Risk factor for chronic health problems.
Waist circumference
Risk factor for chronic health problems.
Waist circumference
Risk factor for chronic health problems.
Hemoglobin A1c levels
Risk factor for chronic health problems.
Hemoglobin A1c levels
Risk factor for chronic health problems.
Hemoglobin A1c levels
Risk factor for chronic health problems.
Blood pressure
Risk factor for chronic health problems.
Blood pressure
Risk factor for chronic health problems.
Blood pressure
Risk factor for chronic health problems.
Total cholesterol/HDL ratio
Risk factor for chronic health problems.
Total cholesterol/HDL ratio
Risk factor for chronic health problems.
Total cholesterol/HDL ratio
Risk factor for chronic health problems.
Physical activity duration
Total minutes per week.
Physical activity duration
Total minutes per week.
Physical activity duration
Total minutes per week.
Number of steps taken per week
Steps taken per week, recorded using a pedometer.
Number of steps taken per week
Steps taken per week, recorded using a pedometer.
Number of steps taken per week
Steps taken per week, recorded using a pedometer.
Exercise stress test (EST)

Full Information

First Posted
December 6, 2013
Last Updated
March 20, 2018
Sponsor
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT02008435
Brief Title
Increasing the Effectiveness of the Diabetes Prevention Program
Official Title
Increasing the Effectiveness of the Diabetes Prevention Program Through If-then Plans and Mental Practice: A Parallel Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Group-delivered Diabetes Prevention Program, Obesity, Overweight, Lifestyle change, Healthy eating, Weight loss, Exercise, Cognitive-behavioral intervention, Implementation intentions, Mental imagery, Mental practice, If-then plans

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enriched GLB
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard GLB
Arm Type
Active Comparator
Arm Description
This arm is the standard Group Lifestyle Balance (GLB) program, which is the group version of the Diabetes Prevention Program developed by the NIH.
Intervention Type
Behavioral
Intervention Name(s)
Enriched GLB
Other Intervention Name(s)
Diabetes Prevention Program, weight loss program, implementation intentions, mental imagery
Intervention Description
Habit formation techniques, namely if-then plans and their mental practice are being added to the standard Group Lifestyle Balance program.
Intervention Type
Behavioral
Intervention Name(s)
Standard GLB
Other Intervention Name(s)
Diabetes Prevention Program, weight loss program
Intervention Description
This arm is the standard Group Lifestyle Balance program
Primary Outcome Measure Information:
Title
Percent body weight loss
Description
The primary outcome will be percent body weight loss from baseline to 3 months after the beginning of the intervention. Weight in kg.
Time Frame
3 months after beginning of the intervention
Secondary Outcome Measure Information:
Title
Percent body weight loss
Description
Percent body weight loss 12 months after the beginning of the intervention. Weight in kg.
Time Frame
12 months
Title
Percent body weight loss
Description
Percent body weight loss 24 months after the beginning of the intervention. Weight in kg.
Time Frame
24 months
Title
Personal weight loss goal
Description
Reaching percent body weight loss goal (7% of body weight) from baseline to 3 months after the beginning of the intervention. Weight in kg.
Time Frame
3 months
Title
Personal weight loss goal
Description
Reaching percent body weight loss goal (7% of body weight) 12 months after the beginning of the intervention. Weight in kg.
Time Frame
12 months
Title
Personal weight loss goal
Description
Reaching percent body weight loss goal (7% of body weight) 24 months after the beginning of the intervention. Weight in kg.
Time Frame
24 months
Title
Personal exercise goal
Description
Reaching exercise goal (150 min/week) from baseline to 3 months after the beginning of the intervention. Sum of minutes over 7 days.
Time Frame
3 months
Title
Personal exercise goal
Description
Reaching exercise goal (150 min/week) 12 months after the beginning of the intervention. Sum of minutes over 7 days.
Time Frame
12 months
Title
Personal exercise goal
Description
Reaching exercise goal (150 min/week) 24 months after the beginning of the intervention. Sum of minutes over 7 days.
Time Frame
24 months
Title
Waist circumference
Description
Risk factor for chronic health problems.
Time Frame
3 months
Title
Waist circumference
Description
Risk factor for chronic health problems.
Time Frame
12 months
Title
Waist circumference
Description
Risk factor for chronic health problems.
Time Frame
24 months
Title
Hemoglobin A1c levels
Description
Risk factor for chronic health problems.
Time Frame
3 months
Title
Hemoglobin A1c levels
Description
Risk factor for chronic health problems.
Time Frame
12 months
Title
Hemoglobin A1c levels
Description
Risk factor for chronic health problems.
Time Frame
24 months
Title
Blood pressure
Description
Risk factor for chronic health problems.
Time Frame
3 months
Title
Blood pressure
Description
Risk factor for chronic health problems.
Time Frame
12 months
Title
Blood pressure
Description
Risk factor for chronic health problems.
Time Frame
24 months
Title
Total cholesterol/HDL ratio
Description
Risk factor for chronic health problems.
Time Frame
3 months
Title
Total cholesterol/HDL ratio
Description
Risk factor for chronic health problems.
Time Frame
12 months
Title
Total cholesterol/HDL ratio
Description
Risk factor for chronic health problems.
Time Frame
24 months
Title
Physical activity duration
Description
Total minutes per week.
Time Frame
3 months
Title
Physical activity duration
Description
Total minutes per week.
Time Frame
12 months
Title
Physical activity duration
Description
Total minutes per week.
Time Frame
24 months
Title
Number of steps taken per week
Description
Steps taken per week, recorded using a pedometer.
Time Frame
3 months
Title
Number of steps taken per week
Description
Steps taken per week, recorded using a pedometer.
Time Frame
12 months
Title
Number of steps taken per week
Description
Steps taken per week, recorded using a pedometer.
Time Frame
24 months
Title
Exercise stress test (EST)
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Self-Report Index of Habit Strength
Description
Self-monitoring and behaviors
Time Frame
3 months
Title
Self-Report Index of Habit Strength
Description
Self-monitoring and behaviors
Time Frame
12 months
Title
Self-Report Index of Habit Strength
Description
Self-monitoring and behaviors
Time Frame
24 months
Title
Habit formation indices of weight tracking
Description
Frequency of weight tracking.
Time Frame
3 months
Title
Habit formation indices of weight tracking
Description
Frequency of weight tracking.
Time Frame
12 months
Title
Habit formation indices of weight tracking
Description
Frequency of weight tracking.
Time Frame
24 months
Title
Habit formation indices of physical activity tracking
Description
Frequency of physical activity tracking.
Time Frame
3 months
Title
Habit formation indices of physical activity tracking
Description
Frequency of physical activity tracking.
Time Frame
12 months
Title
Habit formation indices of physical activity tracking
Description
Frequency of physical activity tracking.
Time Frame
24 months
Title
Habit formation indices of fat grams and calorie tracking
Description
Frequency of food tracking.
Time Frame
3 months
Title
Habit formation indices of fat grams and calorie tracking
Description
Frequency of food tracking.
Time Frame
12 months
Title
Habit formation indices of fat grams and calorie tracking
Description
Frequency of food tracking.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbel Knauper, PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ilka Lowensteyn, PhD
Organizational Affiliation
McGill University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lawrence Joseph, PhD
Organizational Affiliation
McGill University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aleksandra Luszczynska, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Steven Grover, MD
Organizational Affiliation
McGill University
Official's Role
Study Director
Facility Information:
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1B1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
31910891
Citation
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.
Results Reference
derived
PubMed Identifier
29956503
Citation
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.
Results Reference
derived
PubMed Identifier
24885388
Citation
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.
Results Reference
derived

Learn more about this trial

Increasing the Effectiveness of the Diabetes Prevention Program

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