NCT02008435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

4.7 years

First QC Date

December 6, 2013

Last Update Submit

March 20, 2018

Conditions

OverweightObesity

Keywords

Group-delivered Diabetes Prevention ProgramObesityOverweightLifestyle changeHealthy eatingWeight lossExerciseCognitive-behavioral interventionImplementation intentionsMental imageryMental practiceIf-then plans

Outcome Measures

Primary Outcomes (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.

    3 months after beginning of the intervention

Secondary Outcomes (27)

  • Percent body weight loss

    12 months

  • Percent body weight loss

    24 months

  • Personal weight loss goal

    3 months

  • Personal weight loss goal

    12 months

  • Personal weight loss goal

    24 months

  • +22 more secondary outcomes

Other Outcomes (12)

  • Self-Report Index of Habit Strength

    3 months

  • Self-Report Index of Habit Strength

    12 months

  • Self-Report Index of Habit Strength

    24 months

  • +9 more other outcomes

Study Arms (2)

Enriched GLB

EXPERIMENTAL

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

Standard GLB

ACTIVE COMPARATOR

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

Interventions

Enriched GLBBEHAVIORAL

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

Also known as: Diabetes Prevention Program, weight loss program, implementation intentions, mental imagery
Enriched GLB
Standard GLBBEHAVIORAL

This arm is the standard Group Lifestyle Balance program

Also known as: Diabetes Prevention Program, weight loss program
Standard GLB

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, H3A 1B1, Canada

Location

Related Publications (3)

  • 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.

    PMID: 31910891DERIVED

  • 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.

    PMID: 29956503DERIVED

  • 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.

    PMID: 24885388DERIVED

MeSH Terms

Conditions

OverweightObesityWeight LossMotor Activity

Interventions

Weight Reduction Programs

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Intervention Hierarchy (Ancestors)

Health PromotionHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Barbel Knauper, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 6, 2013

First Posted

December 11, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 21, 2018

Record last verified: 2018-03

Locations

CA(1)