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Increasing the Effectiveness of the Diabetes Prevention Program

Increasing the Effectiveness of the Diabetes Prevention Program Through If-then Plans and Mental Practice: A Parallel Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02008435
Enrollment
172
Registered
2013-12-11
Start date
2013-04-30
Completion date
2017-12-31
Last updated
2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Group-delivered Diabetes Prevention Program, Obesity, Overweight, Lifestyle change, Healthy eating, Weight loss, Exercise, Cognitive-behavioral intervention, Implementation intentions, Mental imagery, Mental practice, If-then plans

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.

Interventions

BEHAVIORALEnriched GLB

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

BEHAVIORALStandard GLB

This arm is the standard Group Lifestyle Balance program

Sponsors

McGill University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percent body weight loss3 months after beginning of the interventionThe primary outcome will be percent body weight loss from baseline to 3 months after the beginning of the intervention. Weight in kg.

Secondary

MeasureTime frameDescription
Waist circumference3 monthsRisk factor for chronic health problems.
Total cholesterol/HDL ratio3 monthsRisk factor for chronic health problems.
Physical activity duration3 monthsTotal minutes per week.
Number of steps taken per week3 monthsSteps taken per week, recorded using a pedometer.
Exercise stress test (EST)3 months
Percent body weight loss12 monthsPercent body weight loss 12 months after the beginning of the intervention. Weight in kg.
Personal weight loss goal3 monthsReaching percent body weight loss goal (7% of body weight) from baseline to 3 months after the beginning of the intervention. Weight in kg.
Personal exercise goal3 monthsReaching exercise goal (150 min/week) from baseline to 3 months after the beginning of the intervention. Sum of minutes over 7 days.
Hemoglobin A1c levels3 monthsRisk factor for chronic health problems.
Blood pressure3 monthsRisk factor for chronic health problems.

Other

MeasureTime frameDescription
Habit formation indices of physical activity tracking3 monthsFrequency of physical activity tracking.
Habit formation indices of fat grams and calorie tracking3 monthsFrequency of food tracking.
Habit formation indices of weight tracking3 monthsFrequency of weight tracking.
Self-Report Index of Habit Strength3 monthsSelf-monitoring and behaviors

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026