Increasing the Effectiveness of the Diabetes Prevention Program

McGill University

Status: Completed

Conditions: Overweight; Obesity

Treatments: Behavioral: Standard GLB; Behavioral: Enriched GLB

Study type: Interventional

Funder types: Other

Identifiers

NCT02008435

MOP-123242

Details and patient eligibility

About

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.

Full description

Please see brief summary.

Enrollment: 172 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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172 participants in 2 patient groups

Enriched GLB

Experimental group

Description:

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.

Treatment:

Behavioral: Enriched GLB

Standard GLB

Active Comparator group

Description:

This arm is the standard Group Lifestyle Balance (GLB) program, which is the group version of the Diabetes Prevention Program developed by the NIH.

Treatment:

Behavioral: Standard GLB