Overview

This trial is active, not recruiting.

Conditions overweight, obesity
Treatments enriched glb, standard glb
Sponsor McGill University
Start date April 2013
End date October 2017
Trial size 154 participants
Trial identifier NCT02008435, MOP-123242

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(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.
enriched glb Diabetes Prevention Program
Habit formation techniques, namely if-then plans and their mental practice are being added to the standard Group Lifestyle Balance program.
(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.
standard glb Diabetes Prevention Program
This arm is the standard Group Lifestyle Balance program

Primary Outcomes

Measure
Percent body weight loss
time frame: 3 months after beginning of the intervention

Secondary Outcomes

Measure
Percent body weight loss
time frame: 12 months
Percent body weight loss
time frame: 24 months
Personal weight loss goal
time frame: 3 months
Personal weight loss goal
time frame: 12 months
Personal weight loss goal
time frame: 24 months
Personal exercise goal
time frame: 3 months
Personal exercise goal
time frame: 12 months
Personal exercise goal
time frame: 24 months
Waist circumference
time frame: 3 months
Waist circumference
time frame: 12 months
Waist circumference
time frame: 24 months
Hemoglobin A1c levels
time frame: 3 months
Hemoglobin A1c levels
time frame: 12 months
Hemoglobin A1c levels
time frame: 24 months
Blood pressure
time frame: 3 months
Blood pressure
time frame: 12 months
Blood pressure
time frame: 24 months
Total cholesterol/HDL ratio
time frame: 3 months
Total cholesterol/HDL ratio
time frame: 12 months
Total cholesterol/HDL ratio
time frame: 24 months
Physical activity duration
time frame: 3 months
Physical activity duration
time frame: 12 months
Physical activity duration
time frame: 24 months
Number of steps taken per week
time frame: 3 months
Number of steps taken per week
time frame: 12 months
Number of steps taken per week
time frame: 24 months
Exercise stress test (EST)
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title Increasing the Effectiveness of the Diabetes Prevention Program Through If-then Plans and Mental Practice: A Parallel Randomized Trial
Principal investigator Barbel Knauper, PhD
Description Please see brief summary.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by McGill University.