Back to resultsCognitive-behavioral Weight Loss Treatment
Primary Purpose
Weight
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cognitive behavioral exercise and nutrition over
nutrition and exercise education
Sponsored by
About this trial
This is an interventional treatment trial for Weight
Eligibility 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
Sites / Locations
- YMCA of Metro Atlanta
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive-behavioral
Nurtition education
Arm Description
Those participating in a cognitive behaviorally supported exercise and nutrition treatment will receive a cognitive behavioral exercise and nutrition over 50 weeks
This arm will participate in nutrition and exercise education
Outcomes
Primary Outcome Measures
weight
Direct measurement of weight
Secondary Outcome Measures
Full Information
NCT ID
NCT01693913
First Posted
September 21, 2012
Last Updated
December 27, 2013
Sponsor
YMCA of Metropolitan Atlanta
1. Study Identification
Unique Protocol Identification Number
NCT01693913
Brief Title
Cognitive-behavioral Weight Loss Treatment
Official Title
Effects of a Cognitive-behavioral Weight Loss Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Withdrawn
Why Stopped
IRB approval canceled
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
YMCA of Metropolitan Atlanta
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive-behavioral
Arm Type
Experimental
Arm Description
Those participating in a cognitive behaviorally supported exercise and nutrition treatment will receive a cognitive behavioral exercise and nutrition over 50 weeks
Arm Title
Nurtition education
Arm Type
Active Comparator
Arm Description
This arm will participate in nutrition and exercise education
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral exercise and nutrition over
Intervention Type
Behavioral
Intervention Name(s)
nutrition and exercise education
Primary Outcome Measure Information:
Title
weight
Description
Direct measurement of weight
Time Frame
baseline, months 3,6,12, 24
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James J Annesi, PhD
Organizational Affiliation
YMCA of Metro Atlanta
Official's Role
Principal Investigator
Facility Information:
Facility Name
YMCA of Metro Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22529754
Citation
Annesi JJ. Supported exercise improves controlled eating and weight through its effects on psychosocial factors: extending a systematic research program toward treatment development. Perm J. 2012 Winter;16(1):7-18. doi: 10.7812/11-136.
Results Reference
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PubMed Identifier
21780982
Citation
Annesi JJ, Marti CN. Path analysis of exercise treatment-induced changes in psychological factors leading to weight loss. Psychol Health. 2011 Aug;26(8):1081-98. doi: 10.1080/08870446.2010.534167. Epub 2011 Jul 25.
Results Reference
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PubMed Identifier
21462690
Citation
Annesi JJ, Unruh JL, Marti CN, Gorjala S, Tennant G. Effects of the coach approach intervention on adherence to exercise in obese women: assessing mediation of social cognitive theory factors. Res Q Exerc Sport. 2011 Mar;82(1):99-108. doi: 10.1080/02701367.2011.10599726.
Results Reference
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Cognitive-behavioral Weight Loss Treatment
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