Increasing the Effectiveness of the Diabetes Prevention Program

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008435
• Other study ID #: MOP-123242
• Status: Completed
• Phase: N/A
• First received: December 6, 2013
• Last updated: March 20, 2018
• Start date: April 2013
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Please see brief summary.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Enriched GLB
Habit formation techniques, namely if-then plans and their mental practice are being added to the standard Group Lifestyle Balance program.
• Standard GLB
This arm is the standard Group Lifestyle Balance program

Locations

Country	Name	City	State
Canada	McGill University	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-Report Index of Habit Strength	Self-monitoring and behaviors	3 months
Other	Self-Report Index of Habit Strength	Self-monitoring and behaviors	12 months
Other	Self-Report Index of Habit Strength	Self-monitoring and behaviors	24 months
Other	Habit formation indices of weight tracking	Frequency of weight tracking.	3 months
Other	Habit formation indices of weight tracking	Frequency of weight tracking.	12 months
Other	Habit formation indices of weight tracking	Frequency of weight tracking.	24 months
Other	Habit formation indices of physical activity tracking	Frequency of physical activity tracking.	3 months
Other	Habit formation indices of physical activity tracking	Frequency of physical activity tracking.	12 months
Other	Habit formation indices of physical activity tracking	Frequency of physical activity tracking.	24 months
Other	Habit formation indices of fat grams and calorie tracking	Frequency of food tracking.	3 months
Other	Habit formation indices of fat grams and calorie tracking	Frequency of food tracking.	12 months
Other	Habit formation indices of fat grams and calorie tracking	Frequency of food tracking.	24 months
Primary	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.	3 months after beginning of the intervention
Secondary	Percent body weight loss	Percent body weight loss 12 months after the beginning of the intervention. Weight in kg.	12 months
Secondary	Percent body weight loss	Percent body weight loss 24 months after the beginning of the intervention. Weight in kg.	24 months
Secondary	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.	3 months
Secondary	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.	12 months
Secondary	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.	24 months
Secondary	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.	3 months
Secondary	Personal exercise goal	Reaching exercise goal (150 min/week) 12 months after the beginning of the intervention. Sum of minutes over 7 days.	12 months
Secondary	Personal exercise goal	Reaching exercise goal (150 min/week) 24 months after the beginning of the intervention. Sum of minutes over 7 days.	24 months
Secondary	Waist circumference	Risk factor for chronic health problems.	3 months
Secondary	Waist circumference	Risk factor for chronic health problems.	12 months
Secondary	Waist circumference	Risk factor for chronic health problems.	24 months
Secondary	Hemoglobin A1c levels	Risk factor for chronic health problems.	3 months
Secondary	Hemoglobin A1c levels	Risk factor for chronic health problems.	12 months
Secondary	Hemoglobin A1c levels	Risk factor for chronic health problems.	24 months
Secondary	Blood pressure	Risk factor for chronic health problems.	3 months
Secondary	Blood pressure	Risk factor for chronic health problems.	12 months
Secondary	Blood pressure	Risk factor for chronic health problems.	24 months
Secondary	Total cholesterol/HDL ratio	Risk factor for chronic health problems.	3 months
Secondary	Total cholesterol/HDL ratio	Risk factor for chronic health problems.	12 months
Secondary	Total cholesterol/HDL ratio	Risk factor for chronic health problems.	24 months
Secondary	Physical activity duration	Total minutes per week.	3 months
Secondary	Physical activity duration	Total minutes per week.	12 months
Secondary	Physical activity duration	Total minutes per week.	24 months
Secondary	Number of steps taken per week	Steps taken per week, recorded using a pedometer.	3 months
Secondary	Number of steps taken per week	Steps taken per week, recorded using a pedometer.	12 months
Secondary	Number of steps taken per week	Steps taken per week, recorded using a pedometer.	24 months
Secondary	Exercise stress test (EST)		3 months