Clinical trial NCT02008435: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Percent body weight loss
timeFrame: 3 months after beginning of the intervention
Secondary outcomes:
measure: Percent body weight loss
timeFrame: 12 months
measure: Percent body weight loss
timeFrame: 24 months
measure: Personal weight loss goal
timeFrame: 3 months
measure: Personal weight loss goal
timeFrame: 12 months
measure: Personal weight loss goal
timeFrame: 24 months
measure: Personal exercise goal
timeFrame: 3 months
measure: Personal exercise goal
timeFrame: 12 months
measure: Personal exercise goal
timeFrame: 24 months
measure: Waist circumference
timeFrame: 3 months
measure: Waist circumference
timeFrame: 12 months
measure: Waist circumference
timeFrame: 24 months
measure: Hemoglobin A1c levels
timeFrame: 3 months
measure: Hemoglobin A1c levels
timeFrame: 12 months
measure: Hemoglobin A1c levels
timeFrame: 24 months
measure: Blood pressure
timeFrame: 3 months
measure: Blood pressure
timeFrame: 12 months
measure: Blood pressure
timeFrame: 24 months
measure: Total cholesterol/HDL ratio
timeFrame: 3 months
measure: Total cholesterol/HDL ratio
timeFrame: 12 months
measure: Total cholesterol/HDL ratio
timeFrame: 24 months
measure: Physical activity duration
timeFrame: 3 months
measure: Physical activity duration
timeFrame: 12 months
measure: Physical activity duration
timeFrame: 24 months
measure: Number of steps taken per week
timeFrame: 3 months
measure: Number of steps taken per week
timeFrame: 12 months
measure: Number of steps taken per week
timeFrame: 24 months
measure: Exercise stress test (EST)
timeFrame: 3 months
Other outcomes:
measure: Self-Report Index of Habit Strength
timeFrame: 3 months
measure: Self-Report Index of Habit Strength
timeFrame: 12 months
measure: Self-Report Index of Habit Strength
timeFrame: 24 months
measure: Habit formation indices of weight tracking
timeFrame: 3 months
measure: Habit formation indices of weight tracking
timeFrame: 12 months
measure: Habit formation indices of weight tracking
timeFrame: 24 months
measure: Habit formation indices of physical activity tracking
timeFrame: 3 months
measure: Habit formation indices of physical activity tracking
timeFrame: 12 months
measure: Habit formation indices of physical activity tracking
timeFrame: 24 months
measure: Habit formation indices of fat grams and calorie tracking
timeFrame: 3 months
measure: Habit formation indices of fat grams and calorie tracking
timeFrame: 12 months
measure: Habit formation indices of fat grams and calorie tracking
timeFrame: 24 months
Locations:
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: McGill University
name: Barbel Knauper, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Ilka Lowensteyn, PhD
role: STUDY_DIRECTOR
affiliation: McGill University
name: Lawrence Joseph, PhD
role: STUDY_DIRECTOR
affiliation: University of Colorado, Denver
name: Aleksandra Luszczynska, PhD
role: STUDY_DIRECTOR
affiliation: McGill University
name: Steven Grover, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.