LOSS- Louisiana Obese Subjects Study

This study has been terminated.

( ethical issues of continuing control group without treatment )

Study NCT00115063 Information provided by Pennington Biomedical Research Center

First Received on June 20, 2005. Last Updated on June 7, 2010 History of Changes

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

Hide Participant Flow

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

Hide Baseline Characteristics

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

Baseline Measures

	Intensive Medical Intervention	Access to Weight Loss Informational Website	Total
Number of Participants [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

Show All Outcome Measures

1. Primary:

Percent Change From Baseline Weight [ Time Frame: Baseline, 2 years ]

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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.

Limitations and Caveats

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.

Results Point of Contact:

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

No publications provided by Pennington Biomedical Research Center

Publications automatically indexed to this study:

Johnson WD, Brashear MM, Gupta AK, Rood JC, Ryan DH. Incremental weight loss improves cardiometabolic risk in extremely obese adults. Am J Med. 2011 Oct;124(10):931-8.

Ryan DH, Johnson WD, Myers VH, Prather TL, McGlone MM, Rood J, Brantley PJ, Bray GA, Gupta AK, Broussard AP, Barootes BG, Elkins BL, Gaudin DE, Savory RL, Brock RD, Datz G, Pothakamuri SR, McKnight GT, Stenlof K, Sjöström LV. Nonsurgical weight loss for extreme obesity in primary care settings: results of the Louisiana Obese Subjects Study. Arch Intern Med. 2010 Jan 25;170(2):146-54.

Responsible Party:	Donna H Ryan, MD, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:	NCT00115063 History of Changes
Other Study ID Numbers:	PBRC - OGB -1
Study First Received:	June 20, 2005
Results First Received:	March 1, 2010
Last Updated:	June 7, 2010
Health Authority:	United States: Institutional Review Board