A Trial Comparing Two Approaches to Weight Loss

January 29, 2016 updated by: Robert Carels

A Randomized Trial Comparing Two Approaches to Weight Loss

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.

Study Overview

Status

Completed

Conditions

Intervention / 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

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Bowling Green, Ohio, United States, 43403
        • Bowling Green State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Loss
Time Frame: 10 months
lbs
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caloric Intake
Time Frame: 4 months
kilocalories
4 months
Energy expenditure
Time Frame: 4 months
kilocalories
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Carels

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

January 29, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300066-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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