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LOSS- Louisiana Obese Subjects Study (LOSS)

This study has been terminated.
(ethical issues of continuing control group without treatment)
Sponsor:
Collaborator:
Louisiana Office of Group Benefits
Information provided by (Responsible Party):
Donna H. Ryan, MD, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00115063
First received: June 20, 2005
Last updated: January 22, 2016
Last verified: January 2016
Results First Received: March 1, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Obesity
Interventions: Behavioral: group sessions
Drug: sibutramine, orlistat, diethylpropion
Behavioral: Low Calorie Diet, Health One
Other: Intensive Medical Combination Therapy for Obesity
Other: Control Condition

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intensive Medical Intervention Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a "Tool Box" approach
Access to Weight Loss Informational Website Access to Weight Loss Informational Website sponsored by the Mayo Clinic

Participant Flow:   Overall Study
    Intensive Medical Intervention   Access to Weight Loss Informational Website
STARTED   200   190 
COMPLETED   101   86 
NOT COMPLETED   99   104 
Lost to Follow-up                98                104 
Death                1                0 



  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
Intensive Medical Intervention Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a "Tool Box" approach
Access to Weight Loss Informational Website Access to Weight Loss Informational Website sponsored by the Mayo Clinic
Total Total of all reporting groups

Baseline Measures
   Intensive Medical Intervention   Access to Weight Loss Informational Website   Total 
Overall Participants Analyzed 
[Units: Participants]
 200   190   390 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   200   190   390 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.2  (0.6)   47.1  (0.6)   47.2  (0.6) 
Gender 
[Units: Participants]
     
Female   167   159   326 
Male   33   31   64 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic or Latino   1   0   1 
White   149   147   296 
Black or African American   50   43   93 
Region of Enrollment 
[Units: Participants]
     
United States   200   190   390 


  Outcome Measures
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1.  Primary:   Percent Change From Baseline Weight   [ Time Frame: Baseline, 2 years ]

2.  Secondary:   Change in Weight From Baseline in Kilograms (kg)   [ Time Frame: Baseline, 2 years ]

3.  Secondary:   Change in Blood Pressure   [ Time Frame: Baseline, 2 years ]

4.  Secondary:   Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid   [ Time Frame: Baseline, 2 years ]

5.  Secondary:   Change in Fasting Plasma Glucose (FPG) in Milligrams Per Deciliter (mg/dL)   [ Time Frame: Baseline, 2 years ]

6.  Secondary:   Change in Duke Activity Status Index (DASI) Questionnaire Score   [ Time Frame: Baseline, 2 years ]


  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
The study was stopped prematurely for efforts to be focused on assisting the Office of Group Benefits (OGB) in translating a policy that would allow for physician certification in order to offer participants the intensive treatment.


  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: Tiffany Prather, RN, CDE
Organization: PenningtonBRC
phone: 225-763-2979
e-mail: tiffany.prather@pbrc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Donna H. Ryan, MD, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00115063     History of Changes
Other Study ID Numbers: PBRC 25002
Study First Received: June 20, 2005
Results First Received: March 1, 2010
Last Updated: January 22, 2016
Health Authority: United States: Institutional Review Board