Increasing the Effectiveness of the Diabetes Prevention Program

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by McGill University
Sponsor:
Information provided by (Responsible Party):
Barbel Knauper, McGill University
ClinicalTrials.gov Identifier:
NCT02008435
First received: December 6, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Overweight
Obesity
Behavioral: Enriched GLB
Behavioral: Standard GLB

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Increasing the Effectiveness of the Diabetes Prevention Program Through If-then Plans and Mental Practice: A Parallel Randomized Trial

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • Percent body weight loss [ Time Frame: 3 months after beginning of the intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percent body weight loss 12 months after the beginning of the intervention. Weight in kg.

  • Percent body weight loss [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Percent body weight loss 24 months after the beginning of the intervention. Weight in kg.

  • Personal weight loss goal [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Reaching percent body weight loss goal (7% of body weight) 24 months after the beginning of the intervention. Weight in kg.

  • Personal exercise goal [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Reaching exercise goal (150 min/week) 12 months after the beginning of the intervention. Sum of minutes over 7 days.

  • Personal exercise goal [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Reaching exercise goal (150 min/week) 24 months after the beginning of the intervention. Sum of minutes over 7 days.

  • Waist circumference [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Risk factor for chronic health problems.

  • Waist circumference [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Risk factor for chronic health problems.

  • Waist circumference [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Risk factor for chronic health problems.

  • Hemoglobin A1c levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Risk factor for chronic health problems.

  • Hemoglobin A1c levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Risk factor for chronic health problems.

  • Hemoglobin A1c levels [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Risk factor for chronic health problems.

  • Blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Risk factor for chronic health problems.

  • Blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Risk factor for chronic health problems.

  • Blood pressure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Risk factor for chronic health problems.

  • Total cholesterol/HDL ratio [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Risk factor for chronic health problems.

  • Total cholesterol/HDL ratio [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Risk factor for chronic health problems.

  • Total cholesterol/HDL ratio [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Risk factor for chronic health problems.

  • Physical activity duration [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Total minutes per week.

  • Physical activity duration [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Total minutes per week.

  • Physical activity duration [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Total minutes per week.

  • Number of steps taken per week [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Steps taken per week, recorded using a pedometer.

  • Number of steps taken per week [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Steps taken per week, recorded using a pedometer.

  • Number of steps taken per week [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Steps taken per week, recorded using a pedometer.

  • Exercise stress test (EST) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Self-Report Index of Habit Strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Self-monitoring and behaviors

  • Self-Report Index of Habit Strength [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Self-monitoring and behaviors

  • Self-Report Index of Habit Strength [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Self-monitoring and behaviors

  • Habit formation indices of weight tracking [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Frequency of weight tracking.

  • Habit formation indices of weight tracking [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Frequency of weight tracking.

  • Habit formation indices of weight tracking [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Frequency of weight tracking.

  • Habit formation indices of physical activity tracking [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Frequency of physical activity tracking.

  • Habit formation indices of physical activity tracking [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Frequency of physical activity tracking.

  • Habit formation indices of physical activity tracking [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Frequency of physical activity tracking.

  • Habit formation indices of fat grams and calorie tracking [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Frequency of food tracking.

  • Habit formation indices of fat grams and calorie tracking [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Frequency of food tracking.

  • Habit formation indices of fat grams and calorie tracking [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Frequency of food tracking.


Estimated Enrollment: 154
Study Start Date: April 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Diabetes Prevention Program
  • weight loss program
  • implementation intentions
  • mental imagery
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:
  • Diabetes Prevention Program
  • weight loss program

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men and women
  • ages of 18 and 75
  • overweight or obese (BMI 27-45 kg/m2)
  • sedentary (< 200 min/week of moderate or vigorous exercise)

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02008435

Contacts
Contact: Barbel Knauper, PhD (514) 398 8186 barbel.knauper@mcgill.ca

Locations
Canada, Quebec
McGill University Recruiting
Montreal, Quebec, Canada, H3A 1B1
Contact: Melodie Chamandy, BA    514-398-1399    melodiec@mx0.psych.mcgill.ca   
Principal Investigator: Barbel Knauper, PhD         
Sponsors and Collaborators
McGill University
Investigators
Principal Investigator: Barbel Knauper, PhD McGill University
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
  More Information

No publications provided by McGill University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barbel Knauper, Associate Professor, McGill University
ClinicalTrials.gov Identifier: NCT02008435     History of Changes
Other Study ID Numbers: MOP-123242
Study First Received: December 6, 2013
Last Updated: December 6, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by McGill University:
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

Additional relevant MeSH terms:
Obesity
Overweight
Body Weight
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014