Increasing the Effectiveness of the Diabetes Prevention Program

N/ACompletedNCT02008435

McGill University172 enrolled

Overview

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.

Please see brief summary.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

172

Conditions

Overweight Obesity

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 3 months after beginning of the intervention

Secondary Outcomes

Percent body weight loss

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

Time frame: 12 months

Percent body weight loss

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

Time frame: 24 months

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.

Time frame: 3 months

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.

Time frame: 12 months

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.

Time frame: 24 months

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.

Time frame: 3 months

Personal exercise goal

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

Time frame: 12 months

Personal exercise goal

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

Time frame: 24 months

Waist circumference