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Completed

NCT Number: NCT02008435

Increasing the Effectiveness of the Diabetes Prevention Program

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.

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Key information

Conditions

Overweight Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University

Montreal, Quebec, H3A 1B1, Canada

About this study

Please see brief summary.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enriched GLB

Behavioral

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

Other names: Diabetes Prevention Program, weight loss program, implementation intentions, mental imagery

Standard GLB

Behavioral

This arm is the standard Group Lifestyle Balance program

Other names: Diabetes Prevention Program, weight loss program

Primary outcomes

  1. Percent body weight loss

    Time frame: 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 outcomes

  1. Percent body weight loss

    Time frame: 12 months

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

  2. Percent body weight loss

    Time frame: 24 months

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

  3. Personal weight loss goal

    Time frame: 3 months

    Reaching percent body weight loss goal (7% of body weight) from baseline to 3 months after the beginning of the intervention. Weight in kg.

  4. Personal weight loss goal

    Time frame: 12 months

    Reaching percent body weight loss goal (7% of body weight) 12 months after the beginning of the intervention. Weight in kg.

  5. Personal weight loss goal

    Time frame: 24 months

    Reaching percent body weight loss goal (7% of body weight) 24 months after the beginning of the intervention. Weight in kg.

  6. Personal exercise goal

    Time frame: 3 months

    Reaching exercise goal (150 min/week) from baseline to 3 months after the beginning of the intervention. Sum of minutes over 7 days.

  7. Personal exercise goal

    Time frame: 12 months

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

  8. Personal exercise goal

    Time frame: 24 months

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

  9. Waist circumference

    Time frame: 3 months

    Risk factor for chronic health problems.

  10. Waist circumference

    Time frame: 12 months

    Risk factor for chronic health problems.

  11. Waist circumference

    Time frame: 24 months

    Risk factor for chronic health problems.

  12. Hemoglobin A1c levels

    Time frame: 3 months

    Risk factor for chronic health problems.

  13. Hemoglobin A1c levels

    Time frame: 12 months

    Risk factor for chronic health problems.

  14. Hemoglobin A1c levels

    Time frame: 24 months

    Risk factor for chronic health problems.

  15. Blood pressure

    Time frame: 3 months

    Risk factor for chronic health problems.

  16. Blood pressure

    Time frame: 12 months

    Risk factor for chronic health problems.

  17. Blood pressure

    Time frame: 24 months

    Risk factor for chronic health problems.

  18. Total cholesterol/HDL ratio

    Time frame: 3 months

    Risk factor for chronic health problems.

  19. Total cholesterol/HDL ratio

    Time frame: 12 months

    Risk factor for chronic health problems.

  20. Total cholesterol/HDL ratio

    Time frame: 24 months

    Risk factor for chronic health problems.

  21. Physical activity duration

    Time frame: 3 months

    Total minutes per week.

  22. Physical activity duration

    Time frame: 12 months

    Total minutes per week.

  23. Physical activity duration

    Time frame: 24 months

    Total minutes per week.

  24. Number of steps taken per week

    Time frame: 3 months

    Steps taken per week, recorded using a pedometer.

  25. Number of steps taken per week

    Time frame: 12 months

    Steps taken per week, recorded using a pedometer.

  26. Number of steps taken per week

    Time frame: 24 months

    Steps taken per week, recorded using a pedometer.

  27. Exercise stress test (EST)

    Time frame: 3 months

Other outcomes

  1. Self-Report Index of Habit Strength

    Time frame: 3 months

    Self-monitoring and behaviors

  2. Self-Report Index of Habit Strength

    Time frame: 12 months

    Self-monitoring and behaviors

  3. Self-Report Index of Habit Strength

    Time frame: 24 months

    Self-monitoring and behaviors

  4. Habit formation indices of weight tracking

    Time frame: 3 months

    Frequency of weight tracking.

  5. Habit formation indices of weight tracking

    Time frame: 12 months

    Frequency of weight tracking.

  6. Habit formation indices of weight tracking

    Time frame: 24 months

    Frequency of weight tracking.

  7. Habit formation indices of physical activity tracking

    Time frame: 3 months

    Frequency of physical activity tracking.

  8. Habit formation indices of physical activity tracking

    Time frame: 12 months

    Frequency of physical activity tracking.

  9. Habit formation indices of physical activity tracking

    Time frame: 24 months

    Frequency of physical activity tracking.

  10. Habit formation indices of fat grams and calorie tracking

    Time frame: 3 months

    Frequency of food tracking.

  11. Habit formation indices of fat grams and calorie tracking

    Time frame: 12 months

    Frequency of food tracking.

  12. Habit formation indices of fat grams and calorie tracking

    Time frame: 24 months

    Frequency of food tracking.

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 11, 2013
Registry last updated
Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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