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Cognitive-behavioral Weight Loss Treatment

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: NCT01693913
Recruitment Status : Withdrawn (IRB approval canceled)
First Posted : September 26, 2012
Last Update Posted : December 31, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
That a treatment using a cognitive-behavioral treatment for exercise and nutrition support will be associated with greater weight loss that a treatment of nutrition and exercise education.

Condition or disease Intervention/treatment
Weight Behavioral: cognitive behavioral exercise and nutrition over Behavioral: nutrition and exercise education

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effects of a Cognitive-behavioral Weight Loss Treatment
Study Start Date : October 2012
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cognitive-behavioral
Those participating in a cognitive behaviorally supported exercise and nutrition treatment will receive a cognitive behavioral exercise and nutrition over 50 weeks
Behavioral: cognitive behavioral exercise and nutrition over
Active Comparator: Nurtition education
This arm will participate in nutrition and exercise education
Behavioral: nutrition and exercise education


Outcome Measures

Primary Outcome Measures :
  1. weight [ Time Frame: baseline, months 3,6,12, 24 ]
    Direct measurement of weight


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Ages 21-60
  • Body mass index 30-40 kg/m2

Exclusion Criteria:

  • Pregnancy
  • Medications for a psychological disorder
  • Contraindications for exercise
Contacts and Locations

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): NCT01693913


Locations
United States, Georgia
YMCA of Metro Atlanta
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
YMCA of Metropolitan Atlanta
Investigators
Principal Investigator: James J Annesi, PhD YMCA of Metro Atlanta