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OverweightNCT02008435

Increasing the Effectiveness of the Diabetes Prevention Program

A study testing Enriched GLB and Standard GLB in people with Overweight and Obesity, run by McGill University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Overweight, Obesity
What is being tested?
Enriched GLB and Standard GLB
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
1 siteCanada
Study dates
Apr 2013to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McGill University

    Montreal, Quebec, H3A 1B1

Other trials in Canada

About this study

Official title: 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.

Read the detailed description

Please see brief summary.

Conditions
Overweight, Obesity
Being tested
Enriched GLB, Standard GLB
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
Medical subject headings
Overweight, Obesity, Weight Loss, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enriched GLBBehavioural

    Also called Diabetes Prevention Program, weight loss program, implementation intentions, mental imagery

    Habit formation techniques, namely if-then plans and their mental practice are being added to the standard Group Lifestyle Balance program.

  • Standard GLBBehavioural

    Also called Diabetes Prevention Program, weight loss program

    This arm is the standard Group Lifestyle Balance program

Study groups in NCT02008435
Study groupRoleWhat they receive
Enriched GLBExperimentalThis 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.
Receives: Behavioral: Enriched GLB
Standard GLBActive comparatorThis arm is the standard Group Lifestyle Balance (GLB) program, which is the group version of the Diabetes Prevention Program developed by the NIH.
Receives: Behavioral: Standard GLB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months after beginning of the intervention

Secondary outcomes (27)

  1. Percent body weight loss

    Percent body weight loss 12 months after the beginning of the intervention. Weight in kg.

    Measured: 12 months

  2. Percent body weight loss

    Percent body weight loss 24 months after the beginning of the intervention. Weight in kg.

    Measured: 24 months

  3. 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.

    Measured: 3 months

  4. 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.

    Measured: 12 months

  5. 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.

    Measured: 24 months

  6. 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.

    Measured: 3 months

  7. Personal exercise goal

    Reaching exercise goal (150 min/week) 12 months after the beginning of the intervention. Sum of minutes over 7 days.

    Measured: 12 months

  8. Personal exercise goal

    Reaching exercise goal (150 min/week) 24 months after the beginning of the intervention. Sum of minutes over 7 days.

    Measured: 24 months

  9. Waist circumference

    Risk factor for chronic health problems.

    Measured: 3 months

  10. Waist circumference

    Risk factor for chronic health problems.

    Measured: 12 months

  11. Waist circumference

    Risk factor for chronic health problems.

    Measured: 24 months

  12. Hemoglobin A1c levels

    Risk factor for chronic health problems.

    Measured: 3 months

  13. Hemoglobin A1c levels

    Risk factor for chronic health problems.

    Measured: 12 months

  14. Hemoglobin A1c levels

    Risk factor for chronic health problems.

    Measured: 24 months

  15. Blood pressure

    Risk factor for chronic health problems.

    Measured: 3 months

  16. Blood pressure

    Risk factor for chronic health problems.

    Measured: 12 months

  17. Blood pressure

    Risk factor for chronic health problems.

    Measured: 24 months

  18. Total cholesterol/HDL ratio

    Risk factor for chronic health problems.

    Measured: 3 months

  19. Total cholesterol/HDL ratio

    Risk factor for chronic health problems.

    Measured: 12 months

  20. Total cholesterol/HDL ratio

    Risk factor for chronic health problems.

    Measured: 24 months

  21. Physical activity duration

    Total minutes per week.

    Measured: 3 months

  22. Physical activity duration

    Total minutes per week.

    Measured: 12 months

  23. Physical activity duration

    Total minutes per week.

    Measured: 24 months

  24. Number of steps taken per week

    Steps taken per week, recorded using a pedometer.

    Measured: 3 months

  25. Number of steps taken per week

    Steps taken per week, recorded using a pedometer.

    Measured: 12 months

  26. Number of steps taken per week

    Steps taken per week, recorded using a pedometer.

    Measured: 24 months

  27. Exercise stress test (EST)

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02008435
Sponsor's protocol ID
MOP-123242
Status last verified
Mar 2018
First submitted
6 Dec 2013
Last updated
21 Mar 2018
Results posted
No
Data monitoring committee
No

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.

    PubMed 31910891

  • 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.

    PubMed 29956503

  • 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.

    PubMed 24885388

Questions about this trial

What is this clinical trial studying?

A study testing Enriched GLB and Standard GLB in people with Overweight and Obesity, run by McGill University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent body weight loss (time frame: 3 months after beginning of the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02008435, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.

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