Increasing the Effectiveness of the Diabetes Prevention Program

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Behavioral: Standard GLB; Behavioral: Enriched GLB

• Registration Number: NCT02008435
• Lead Sponsor: McGill University

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.

Detailed Description

Please see brief summary.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-12-06
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-11
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard GLB	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.
Enriched GLB	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.

Primary Outcome Measures

Name	Time	Method
Percent body weight loss	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.

Secondary Outcome Measures

Name	Time	Method
Exercise stress test (EST)	3 months
Personal exercise goal	24 months	Reaching exercise goal (150 min/week) 24 months after the beginning of the intervention. Sum of minutes over 7 days.
Total cholesterol/HDL ratio	24 months	Risk factor for chronic health problems.
Number of steps taken per week	24 months	Steps taken per week, recorded using a pedometer.
Hemoglobin A1c levels	24 months	Risk factor for chronic health problems.
Physical activity duration	24 months	Total minutes per week.
Percent body weight loss	24 months	Percent body weight loss 24 months after the beginning of the intervention. Weight in kg.
Personal weight loss goal	24 months	Reaching percent body weight loss goal (7% of body weight) 24 months after the beginning of the intervention. Weight in kg.
Waist circumference	24 months	Risk factor for chronic health problems.
Blood pressure	24 months	Risk factor for chronic health problems.

Trial Locations

Locations (1)

McGill University; 🇨🇦 Montreal, Quebec, Canada