Trial · NCT00115063
LOSS- Louisiana Obese Subjects Study
NCT00115063, Phase 4, Terminated, Pennington Biomedical Research Center; results first posted 2010-06-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. LOSS- Louisiana Obese Subjects Study. Trials, record NCT00115063. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00115063
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LOSS- Louisiana Obese Subjects Study
- NCT number
- NCT00115063
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 390 participants, actual
- Lead sponsor
- Pennington Biomedical Research Center
- Conditions
- Obesity
- Interventions
- group sessions, sibutramine, orlistat, diethylpropion, Low Calorie Diet, Health One, Intensive Medical Combination Therapy for Obesity, Control Condition
- First posted
- 2005-06-21
- Last updated
- 2016-02-22
- Results first posted
- 2010-06-07
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline Weight | Baseline, 2 years | |
| Secondary | Change in Weight From Baseline in Kilograms (kg) | Baseline, 2 years | |
| Secondary | Change in Blood Pressure | Baseline, 2 years | |
| Secondary | Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid | Baseline, 2 years | |
| Secondary | Change in Fasting Plasma Glucose (FPG) in Milligrams Per Deciliter (mg/dL) | Baseline, 2 years | |
| Secondary | Change in Duke Activity Status Index (DASI) Questionnaire Score | Baseline, 2 years | The DASI was used to access changes in fuctional capacity during the study. The highest score possible is 58.2 and the lowest is 0. The score for each individual question varied depending on the intensity of the activity being evaluated. The higher the score, the more physically active a person is to this set of activities of daily living questions. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline Weight | Baseline, 2 years | This analysis was done on the completers, those that completed the 2 year study visit. | Percent change | MEAN |
| SECONDARY | Change in Weight From Baseline in Kilograms (kg) | Baseline, 2 years | This analysis was done on the completers, those that completed the 2 year study visit. | kg | MEAN |
| SECONDARY | Change in Blood Pressure | Baseline, 2 years | This analysis was done on the completers, those that completed the 2 year study visit. | millimeter of mercury (mm Hg) | MEAN |
| SECONDARY | Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid | Baseline, 2 years | This analysis was done on the completers, those that completed the 2 year study visit. | Percent change | MEAN |
| SECONDARY | Change in Fasting Plasma Glucose (FPG) in Milligrams Per Deciliter (mg/dL) | Baseline, 2 years | This analysis was done on the completers, those that completed the 2 year study visit. | mg/dL | MEAN |
| SECONDARY | Change in Duke Activity Status Index (DASI) Questionnaire Score | Baseline, 2 years | This analysis was done on the completers, those that completed the 2 year study visit. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline Weight | Intensive Medical Intervention | -9.7 | Standard Error 1.3 | Percent change | |
| Percent Change From Baseline Weight | Access to Weight Loss Informational Website | -0.4 | Standard Error 0.7 | Percent change | |
| Change in Weight From Baseline in Kilograms (kg) | Intensive Medical Intervention | -12.7 | Standard Error 1.7 | kg | |
| Change in Weight From Baseline in Kilograms (kg) | Access to Weight Loss Informational Website | -0.5 | Standard Error 0.9 | kg | |
| Change in Blood Pressure | Intensive Medical Intervention | systolic blood pressure | -14.7 | Standard Error 2.4 | millimeter of mercury (mm Hg) |
| Change in Blood Pressure | Access to Weight Loss Informational Website | systolic blood pressure | -8.6 | Standard Error 2.6 | millimeter of mercury (mm Hg) |
| Change in Blood Pressure | Intensive Medical Intervention | dystolic blood pressure | -4.4 | Standard Error 1.8 | millimeter of mercury (mm Hg) |
| Change in Blood Pressure | Access to Weight Loss Informational Website | dystolic blood pressure | -3.2 | Standard Error 1.5 | millimeter of mercury (mm Hg) |
| Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid | Intensive Medical Intervention | LDL | 1.8 | Standard Error 2.4 | Percent change |
| Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid | Access to Weight Loss Informational Website | LDL | 0.7 | Standard Error 2.4 | Percent change |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intensive Medical Intervention | 200 | |
| Overall Study | STARTED | Access to Weight Loss Informational Website | 190 | |
| Overall Study | COMPLETED | Intensive Medical Intervention | 101 | |
| Overall Study | COMPLETED | Access to Weight Loss Informational Website | 86 | |
| Overall Study | NOT COMPLETED | Intensive Medical Intervention | 99 | |
| Overall Study | NOT COMPLETED | Access to Weight Loss Informational Website | 104 |
Source ClinicalTrials.gov
Adverse events50
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Hernia repair | Gastrointestinal disorders | Intensive Medical Intervention | 2 | 200 | 2 |
| serious | Hernia repair | Gastrointestinal disorders | Access to Weight Loss Informational Website | 0 | 190 | 0 |
| serious | Hospitalization for coronary stent replacement | Vascular disorders | Intensive Medical Intervention | 1 | 200 | 1 |
| serious | Hospitalization for coronary stent replacement | Vascular disorders | Access to Weight Loss Informational Website | 0 | 190 | 0 |
| serious | Hospitalization for deep vein thrombosis | Vascular disorders | Intensive Medical Intervention | 1 | 200 | 1 |
| serious | Hospitalization for deep vein thrombosis | Vascular disorders | Access to Weight Loss Informational Website | 0 | 190 | 0 |
| serious | Surgery for cyctocele | Renal and urinary disorders | Intensive Medical Intervention | 1 | 200 | 1 |
| serious | Surgery for cyctocele | Renal and urinary disorders | Access to Weight Loss Informational Website | 0 | 190 | 0 |
| serious | Surgical incision and drainage of abscess | Surgical and medical procedures | Intensive Medical Intervention | 1 | 200 | 1 |
| serious | Surgical incision and drainage of abscess | Surgical and medical procedures | Access to Weight Loss Informational Website | 0 | 190 | 0 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intensive Medical Intervention | ||
| Total, all-cause mortality | Access to Weight Loss Informational Website | ||
| Total, other adverse events | Intensive Medical Intervention | 0 | 0 |
| Total, other adverse events | Access to Weight Loss Informational Website | 0 | 0 |
| Total, serious adverse events | Intensive Medical Intervention | 20 | 200 |
| Total, serious adverse events | Access to Weight Loss Informational Website | 8 | 190 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Intensive Medical Intervention vs Access to Weight Loss Informational Website: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00115063
GET https://conductscience.org/api/trials/v1/NCT00115063/events?page=2