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A Trial Comparing Two Approaches to Weight Loss

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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

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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Transforming Your Life Behavioral: Diabetes Prevention Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Two Approaches to Weight Loss
Study Start Date : August 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Transforming Your Life
See Transforming Your Life Arm

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.
Behavioral: Diabetes Prevention Program
See Diabetes Prevention Program Arm




Primary Outcome Measures :
  1. Weight Loss [ Time Frame: 10 months ]
    lbs


Secondary Outcome Measures :
  1. Caloric Intake [ Time Frame: 4 months ]
    kilocalories

  2. Energy expenditure [ Time Frame: 4 months ]
    kilocalories



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671110


Locations
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United States, Ohio
Bowling Green State University
Bowling Green, Ohio, United States, 43403
Sponsors and Collaborators
Robert Carels
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Responsible Party: Robert Carels, Professor, Bowling Green State University
ClinicalTrials.gov Identifier: NCT02671110    
Other Study ID Numbers: 300066-10
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016
Keywords provided by Robert Carels, Bowling Green State University:
weight loss treatment
Obesity
Additional relevant MeSH terms:
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Overweight
Weight Loss
Body Weight
Body Weight Changes