Cognitive-behavioral Weight Loss Treatment

This study has been withdrawn prior to enrollment.
(IRB approval canceled)
Sponsor:
Information provided by (Responsible Party):
YMCA of Metropolitan Atlanta
ClinicalTrials.gov Identifier:
NCT01693913
First received: September 21, 2012
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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 Intervention
Weight
Behavioral: cognitive behavioral exercise and nutrition over
Behavioral: nutrition and exercise education

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effects of a Cognitive-behavioral Weight Loss Treatment

Resource links provided by NLM:


Further study details as provided by YMCA of Metropolitan Atlanta:

Primary Outcome Measures:
  • weight [ Time Frame: baseline, months 3,6,12, 24 ] [ Designated as safety issue: No ]
    Direct measurement of weight


Enrollment: 0
Study Start Date: October 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information