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A Trial Comparing Two Approaches to Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671110
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Robert Carels, Bowling Green State University

Tracking Information
First Submitted Date  ICMJE November 2, 2015
First Posted Date  ICMJE February 2, 2016
Last Update Posted Date February 2, 2016
Study Start Date  ICMJE August 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
Weight Loss [ Time Frame: 10 months ]
lbs
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
  • Caloric Intake [ Time Frame: 4 months ]
    kilocalories
  • Energy expenditure [ Time Frame: 4 months ]
    kilocalories
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Comparing Two Approaches to Weight Loss
Official Title  ICMJE A Randomized Trial Comparing Two Approaches to Weight Loss
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Overweight and Obesity
Intervention  ICMJE
  • Behavioral: Transforming Your Life
    See Transforming Your Life Arm
  • Behavioral: Diabetes Prevention Program
    See Diabetes Prevention Program Arm
Study Arms  ICMJE
  • Experimental: Transforming Your Life
    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.
    Intervention: Behavioral: Transforming Your Life
  • Active Comparator: Diabetes Prevention program
    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: Behavioral: Diabetes Prevention Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2016)
98
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. overweight/obese (body mass index>27 kg/m2)
  2. 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)
  3. had not undergone bariatric surgery
  4. able to provide medical clearance from their physician.

Exclusion Criteria

  1. 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)
  2. had undergone bariatric surgery,
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02671110
Other Study ID Numbers  ICMJE 300066-10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert Carels, Bowling Green State University
Study Sponsor  ICMJE Robert Carels
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bowling Green State University
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP