Trial Outcomes & Findings for LOSS- Louisiana Obese Subjects Study (NCT NCT00115063)
NCT ID: NCT00115063
Last Updated: 2016-02-22
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
390 participants
Primary outcome timeframe
Baseline, 2 years
Results posted on
2016-02-22
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
190
|
|
Overall Study
COMPLETED
|
101
|
86
|
|
Overall Study
NOT COMPLETED
|
99
|
104
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
98
|
104
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
LOSS- Louisiana Obese Subjects Study
Baseline characteristics by cohort
| Measure |
Intensive Medical Intervention
n=200 Participants
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
n=190 Participants
Access to Weight Loss Informational Website sponsored by the Mayo Clinic
|
Total
n=390 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
200 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
390 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 0.6 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 0.6 • n=7 Participants
|
47.2 years
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
167 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
326 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
149 participants
n=5 Participants
|
147 participants
n=7 Participants
|
296 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
50 participants
n=5 Participants
|
43 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
200 participants
n=5 Participants
|
190 participants
n=7 Participants
|
390 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 yearsPopulation: This analysis was done on the completers, those that completed the 2 year study visit.
Outcome measures
| Measure |
Intensive Medical Intervention
n=101 Participants
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
n=86 Participants
Access to Weight Loss Informational Website sponsored by the Mayo Clinic
|
|---|---|---|
|
Percent Change From Baseline Weight
|
-9.7 Percent change
Standard Error 1.3
|
-0.4 Percent change
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline, 2 yearsPopulation: This analysis was done on the completers, those that completed the 2 year study visit.
Outcome measures
| Measure |
Intensive Medical Intervention
n=101 Participants
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
n=86 Participants
Access to Weight Loss Informational Website sponsored by the Mayo Clinic
|
|---|---|---|
|
Change in Weight From Baseline in Kilograms (kg)
|
-12.7 kg
Standard Error 1.7
|
-0.5 kg
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Baseline, 2 yearsPopulation: This analysis was done on the completers, those that completed the 2 year study visit.
Outcome measures
| Measure |
Intensive Medical Intervention
n=101 Participants
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
n=86 Participants
Access to Weight Loss Informational Website sponsored by the Mayo Clinic
|
|---|---|---|
|
Change in Blood Pressure
dystolic blood pressure
|
-4.4 millimeter of mercury (mm Hg)
Standard Error 1.8
|
-3.2 millimeter of mercury (mm Hg)
Standard Error 1.5
|
|
Change in Blood Pressure
systolic blood pressure
|
-14.7 millimeter of mercury (mm Hg)
Standard Error 2.4
|
-8.6 millimeter of mercury (mm Hg)
Standard Error 2.6
|
SECONDARY outcome
Timeframe: Baseline, 2 yearsPopulation: This analysis was done on the completers, those that completed the 2 year study visit.
Outcome measures
| Measure |
Intensive Medical Intervention
n=101 Participants
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
n=86 Participants
Access to Weight Loss Informational Website sponsored by the Mayo Clinic
|
|---|---|---|
|
Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid
LDL
|
1.8 Percent change
Standard Error 2.4
|
0.7 Percent change
Standard Error 2.4
|
|
Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid
HDL
|
7.9 Percent change
Standard Error 1.8
|
1.5 Percent change
Standard Error 1.8
|
|
Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid
Triglycerides
|
-9.2 Percent change
Standard Error 3.5
|
-4.8 Percent change
Standard Error 4.3
|
|
Percent Change in Blood Tests- Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Triglycerides and Uric Acid
Uric Acid
|
-3.0 Percent change
Standard Error 2.4
|
3.1 Percent change
Standard Error 1.8
|
SECONDARY outcome
Timeframe: Baseline, 2 yearsPopulation: This analysis was done on the completers, those that completed the 2 year study visit.
Outcome measures
| Measure |
Intensive Medical Intervention
n=101 Participants
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
n=86 Participants
Access to Weight Loss Informational Website sponsored by the Mayo Clinic
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) in Milligrams Per Deciliter (mg/dL)
|
2.4 mg/dL
Standard Error 2.1
|
6.7 mg/dL
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Baseline, 2 yearsPopulation: This analysis was done on the completers, those that completed the 2 year study visit.
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.
Outcome measures
| Measure |
Intensive Medical Intervention
n=101 Participants
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
n=86 Participants
Access to Weight Loss Informational Website sponsored by the Mayo Clinic
|
|---|---|---|
|
Change in Duke Activity Status Index (DASI) Questionnaire Score
|
-2.1 units on a scale
Standard Error 1.7
|
-11.6 units on a scale
Standard Error 2.0
|
Adverse Events
Intensive Medical Intervention
Serious events: 20 serious events
Other events: 0 other events
Deaths: 0 deaths
Access to Weight Loss Informational Website
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intensive Medical Intervention
n=200 participants at risk
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
n=190 participants at risk
Access to Weight Loss Informational Website sponsored by the Mayo Clinic
|
|---|---|---|
|
Gastrointestinal disorders
Hernia repair
|
1.0%
2/200 • Number of events 2 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.00%
0/190 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Vascular disorders
Hospitalization for coronary stent replacement
|
0.50%
1/200 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.00%
0/190 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Vascular disorders
Hospitalization for deep vein thrombosis
|
0.50%
1/200 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.00%
0/190 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Renal and urinary disorders
Surgery for cyctocele
|
0.50%
1/200 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.00%
0/190 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Surgical and medical procedures
Surgical incision and drainage of abscess
|
0.50%
1/200 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.00%
0/190 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for pneumonia
|
0.50%
1/200 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.00%
0/190 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Psychiatric disorders
Hospitalization for hallucinations
|
0.50%
1/200 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.00%
0/190 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Musculoskeletal and connective tissue disorders
Hospitalization for arm fracture
|
0.50%
1/200 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.00%
0/190 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Renal and urinary disorders
Hospitalization for nephrolithiasis
|
0.50%
1/200 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.00%
0/190 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for asthma and bronchitis
|
0.50%
1/200 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.00%
0/190 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Cardiac disorders
Chest heaviness
|
0.50%
1/200 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.00%
0/190 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Cardiac disorders
Elevated blood pressure and mood swings
|
0.50%
1/200 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.00%
0/190 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Cardiac disorders
Chest pain
|
1.0%
2/200 • Number of events 2 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.00%
0/190 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Musculoskeletal and connective tissue disorders
Cervical disk surgery
|
0.50%
1/200 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.00%
0/190 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Gastrointestinal disorders
Bleeding duodenal ulcer
|
0.50%
1/200 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.00%
0/190 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Cardiac disorders
Death
|
0.50%
1/200 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.00%
0/190 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Musculoskeletal and connective tissue disorders
Total knee replacement surgery
|
0.50%
1/200 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.53%
1/190 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Cardiac disorders
New-onset atrial fibrillation
|
0.50%
1/200 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.00%
0/190 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Cardiac disorders
Hospitalization for acute myocardial infarction
|
0.00%
0/200 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.53%
1/190 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Surgical and medical procedures
Pacemaker insertion procedure
|
0.00%
0/200 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.53%
1/190 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Musculoskeletal and connective tissue disorders
Hospitalization for back surgery
|
0.00%
0/200 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.53%
1/190 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Metabolism and nutrition disorders
Hospitalization for hypokalemia
|
0.00%
0/200 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.53%
1/190 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Surgical and medical procedures
Hospitalization for stent placement
|
0.00%
0/200 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.53%
1/190 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Reproductive system and breast disorders
Hysterectomy
|
0.00%
0/200 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.53%
1/190 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/200 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
0.53%
1/190 • Number of events 1 • Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Only serious adverse events were tracked for this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place