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NCT02671110 Clinical Trial

A Trial Comparing Two Approaches to Weight Loss

Overweight and Obesity Clinical Trial

Official title:
A Randomized Trial Comparing Two Approaches to Weight Loss

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02671110
Other study ID # 300066-10
Secondary ID
Status Completed
Phase N/A
First received November 2, 2015
Last updated January 29, 2016
Start date August 2013
Est. completion date December 2014

Study information
Verified date January 2016
Source Bowling Green State University
Contact n/a
Is FDA regulated No
Health authority United States: Data and Safety Monitoring Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 98
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years and older
Eligibility 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,

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Transforming Your Life
See Transforming Your Life Arm
• Diabetes Prevention Program
See Diabetes Prevention Program Arm

Locations
Country Name City State
United States Bowling Green State University Bowling Green Ohio

Sponsors (1)
Lead Sponsor Collaborator
Robert Carels

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight Loss lbs 10 months No
Secondary Caloric Intake kilocalories 4 months No
Secondary Energy expenditure kilocalories 4 months No
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