Increasing the Effectiveness of the Diabetes Prevention Program

March 20, 2018 updated by: Barbel Knauper, McGill University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Please see brief summary.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent body weight loss
Time Frame: 3 months after beginning of the intervention
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent body weight loss
Time Frame: 12 months
Percent body weight loss 12 months after the beginning of the intervention. Weight in kg.
12 months
Percent body weight loss
Time Frame: 24 months
Percent body weight loss 24 months after the beginning of the intervention. Weight in kg.
24 months
Personal weight loss goal
Time Frame: 3 months
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
Time Frame: 12 months
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
Time Frame: 24 months
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
Time Frame: 3 months
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
Time Frame: 12 months
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
Time Frame: 24 months
Reaching exercise goal (150 min/week) 24 months after the beginning of the intervention. Sum of minutes over 7 days.
24 months
Waist circumference
Time Frame: 3 months
Risk factor for chronic health problems.
3 months
Waist circumference
Time Frame: 12 months
Risk factor for chronic health problems.
12 months
Waist circumference
Time Frame: 24 months
Risk factor for chronic health problems.
24 months
Hemoglobin A1c levels
Time Frame: 3 months
Risk factor for chronic health problems.
3 months
Hemoglobin A1c levels
Time Frame: 12 months
Risk factor for chronic health problems.
12 months
Hemoglobin A1c levels
Time Frame: 24 months
Risk factor for chronic health problems.
24 months
Blood pressure
Time Frame: 3 months
Risk factor for chronic health problems.
3 months
Blood pressure
Time Frame: 12 months
Risk factor for chronic health problems.
12 months
Blood pressure
Time Frame: 24 months
Risk factor for chronic health problems.
24 months
Total cholesterol/HDL ratio
Time Frame: 3 months
Risk factor for chronic health problems.
3 months
Total cholesterol/HDL ratio
Time Frame: 12 months
Risk factor for chronic health problems.
12 months
Total cholesterol/HDL ratio
Time Frame: 24 months
Risk factor for chronic health problems.
24 months
Physical activity duration
Time Frame: 3 months
Total minutes per week.
3 months
Physical activity duration
Time Frame: 12 months
Total minutes per week.
12 months
Physical activity duration
Time Frame: 24 months
Total minutes per week.
24 months
Number of steps taken per week
Time Frame: 3 months
Steps taken per week, recorded using a pedometer.
3 months
Number of steps taken per week
Time Frame: 12 months
Steps taken per week, recorded using a pedometer.
12 months
Number of steps taken per week
Time Frame: 24 months
Steps taken per week, recorded using a pedometer.
24 months
Exercise stress test (EST)
Time Frame: 3 months
3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-Report Index of Habit Strength
Time Frame: 3 months
Self-monitoring and behaviors
3 months
Self-Report Index of Habit Strength
Time Frame: 12 months
Self-monitoring and behaviors
12 months
Self-Report Index of Habit Strength
Time Frame: 24 months
Self-monitoring and behaviors
24 months
Habit formation indices of weight tracking
Time Frame: 3 months
Frequency of weight tracking.
3 months
Habit formation indices of weight tracking
Time Frame: 12 months
Frequency of weight tracking.
12 months
Habit formation indices of weight tracking
Time Frame: 24 months
Frequency of weight tracking.
24 months
Habit formation indices of physical activity tracking
Time Frame: 3 months
Frequency of physical activity tracking.
3 months
Habit formation indices of physical activity tracking
Time Frame: 12 months
Frequency of physical activity tracking.
12 months
Habit formation indices of physical activity tracking
Time Frame: 24 months
Frequency of physical activity tracking.
24 months
Habit formation indices of fat grams and calorie tracking
Time Frame: 3 months
Frequency of food tracking.
3 months
Habit formation indices of fat grams and calorie tracking
Time Frame: 12 months
Frequency of food tracking.
12 months
Habit formation indices of fat grams and calorie tracking
Time Frame: 24 months
Frequency of food tracking.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MOP-123242

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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