Biological Effects of Weight Loss In Older, Obese Women (WL+E)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01032733
First received: December 14, 2009
Last updated: May 11, 2012
Last verified: May 2012
Results First Received: February 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Obesity
Sarcopenia
Interventions: Behavioral: Lifestyle Counseling
Other: Educational Control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited between September 2006 – December 2008 through a variety of methods including media articles, direct mailings, newspaper announcements, and presentations to community groups.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following telephone screening, potentially eligible persons were invited to attend a screening visit during which the purposes and procedures of the study were explained and informed consent was obtained.

Reporting Groups
  Description
Lifestyle Counseling In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
Educational Control Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.

Participant Flow:   Overall Study
    Lifestyle Counseling     Educational Control  
STARTED     17     17  
COMPLETED     16     16  
NOT COMPLETED     1     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lifestyle Counseling In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
Educational Control Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
Total Total of all reporting groups

Baseline Measures
    Lifestyle Counseling     Educational Control     Total  
Number of Participants  
[units: participants]
  17     17     34  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     11     23  
>=65 years     5     6     11  
Age  
[units: years]
Mean ± Standard Deviation
  63.7  ± 4.5     63.7  ± 6.7     63.7  ± 5.59  
Gender  
[units: participants]
     
Female     17     17     34  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     17     17     34  



  Outcome Measures
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1.  Primary:   Performance on the 400 Meter Walk   [ Time Frame: 24 weeks ]

2.  Secondary:   Body Weight   [ Time Frame: 24 weeks ]

3.  Secondary:   Short Physical Performance Battery   [ Time Frame: 24 weeks ]

4.  Secondary:   Knee Extension Maximum Isokinetic Strength (Weight Lifted in Kilograms).   [ Time Frame: 24 weeks ]

5.  Secondary:   Mitochondrial Function (Cox IV Subunit)   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations include the following: (1) the sample size was relatively small,(2)the study was not adequately powered to detect differences between African American and Caucasian women in response to the intervention, (3) inclusion of only women.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Stephen Anton
Organization: University of Florida
phone: 352-273-7514
e-mail: santon@ufl.edu


Publications of Results:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01032733     History of Changes
Other Study ID Numbers: 3992006, P30AG028740
Study First Received: December 14, 2009
Results First Received: February 14, 2012
Last Updated: May 11, 2012
Health Authority: United States: Institutional Review Board