Increasing the Effectiveness of the Diabetes Prevention Program

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Behavioral: Enriched GLB; Behavioral: Standard GLB

Detailed Description

Please see brief summary.

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A 1B1
      • McGill University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Enriched GLB; Habit formation techniques, namely if-then plans and their mental practice are being added to the standard Group Lifestyle Balance program.; Other Names: mental imagery; implementation intentions; weight loss program; Diabetes Prevention Program
Active Comparator: 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.	Behavioral: Standard GLB; This arm is the standard Group Lifestyle Balance program; Other Names: weight loss program; Diabetes Prevention Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: McGill University
• Investigators: Study Director: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 6, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 11, 2013

Study Record Updates

• Last Update Posted (Actual): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Exercise; Obesity; Overweight; Weight loss; Healthy eating; Implementation intentions; Lifestyle change; Mental imagery; Mental practice; Cognitive-behavioral intervention; Group-delivered Diabetes Prevention Program; If-then plans
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: MOP-123242