Back to resultsA Trial Comparing Two Approaches to Weight Loss
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transforming Your Life
Diabetes Prevention Program
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring weight loss treatment, Obesity
Eligibility Criteria
Inclusion Criteria
- overweight/obese (body mass index>27 kg/m2)
- free from serious medical conditions that would complicate participation in the intervention via adherence or mobility (e.g., serious heart disease or musculoskeletal problems that would interfere with moderate exercise)
- had not undergone bariatric surgery
- able to provide medical clearance from their physician.
Exclusion Criteria
- evidence of medical conditions that would complicate participation in the intervention via adherence or mobility (e.g., serious heart disease or musculoskeletal problems that would interfere with moderate exercise)
- had undergone bariatric surgery,
Sites / Locations
- Bowling Green State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transforming Your Life
Diabetes Prevention program
Arm Description
The TYL program emphasized: 1) helping participants develop and maintain healthy habits and disrupt unhealthy habits, 2) enabling participants to create a personal food and exercise environment that increases exposure to healthy eating and physical activity and encourages automatic responding to goal-related cues, and 3) facilitating participants' weight loss motivation.
The DPP recommends that participants set a weight loss reduction goal of 7% or more of their baseline body weight, reduce consumption of high fat foods as a means to reduce caloric intake, and engage in brisk walking or other moderate intensity physical activity for 150 minutes per week. Sessions include information on changing energy intake and energy output through diet and exercise, and addressing psychological, social, environmental, and motivational challenges to health behavior change.
Outcomes
Primary Outcome Measures
Weight Loss
lbs
Secondary Outcome Measures
Caloric Intake
kilocalories
Energy expenditure
kilocalories
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02671110
Brief Title
A Trial Comparing Two Approaches to Weight Loss
Official Title
A Randomized Trial Comparing Two Approaches to Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Robert Carels
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study compared the recently developed Transforming Your Life (TYL) weight loss program to the Diabetes Prevention Program (DPP), considered the "Gold Standard" in behavioral weight loss treatment.
Detailed Description
Weight loss programs evidence considerable variability in treatment outcomes and weight regain is common, signaling the need for the refinement of effective treatments. This study compared the recently developed Transforming Your Life (TYL) program to the Diabetes Prevention Program (DPP), considered the "Gold Standard" in behavioral weight loss treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
weight loss treatment, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transforming Your Life
Arm Type
Experimental
Arm Description
The TYL program emphasized: 1) helping participants develop and maintain healthy habits and disrupt unhealthy habits, 2) enabling participants to create a personal food and exercise environment that increases exposure to healthy eating and physical activity and encourages automatic responding to goal-related cues, and 3) facilitating participants' weight loss motivation.
Arm Title
Diabetes Prevention program
Arm Type
Active Comparator
Arm Description
The DPP recommends that participants set a weight loss reduction goal of 7% or more of their baseline body weight, reduce consumption of high fat foods as a means to reduce caloric intake, and engage in brisk walking or other moderate intensity physical activity for 150 minutes per week. Sessions include information on changing energy intake and energy output through diet and exercise, and addressing psychological, social, environmental, and motivational challenges to health behavior change.
Intervention Type
Behavioral
Intervention Name(s)
Transforming Your Life
Intervention Description
See Transforming Your Life Arm
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Prevention Program
Intervention Description
See Diabetes Prevention Program Arm
Primary Outcome Measure Information:
Title
Weight Loss
Description
lbs
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Caloric Intake
Description
kilocalories
Time Frame
4 months
Title
Energy expenditure
Description
kilocalories
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
overweight/obese (body mass index>27 kg/m2)
free from serious medical conditions that would complicate participation in the intervention via adherence or mobility (e.g., serious heart disease or musculoskeletal problems that would interfere with moderate exercise)
had not undergone bariatric surgery
able to provide medical clearance from their physician.
Exclusion Criteria
evidence of medical conditions that would complicate participation in the intervention via adherence or mobility (e.g., serious heart disease or musculoskeletal problems that would interfere with moderate exercise)
had undergone bariatric surgery,
Facility Information:
Facility Name
Bowling Green State University
City
Bowling Green
State/Province
Ohio
ZIP/Postal Code
43403
Country
United States
12. IPD Sharing Statement
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A Trial Comparing Two Approaches to Weight Loss
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