Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115063
Status:
TERMINATED
Last Update Posted:
2016-02-22
First Post:
2005-06-20
Brief Title:
LOSS- Louisiana Obese Subjects Study
Sponsor:
Pennington Biomedical Research Center
Organization:
Pennington Biomedical Research Center
Study Overview
Official Title:
Loss - Louisiana Obese Subjects Study
Status:
TERMINATED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
ethical issues of continuing control group without treatment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOSS
Brief Summary:
LOSS is a pragmatic clinical evaluation of intensive medical approaches to weight loss for individuals with extreme obesity body mass index BMI 40-60 kgm2 The intensive medical treatment is designed to produce 25 weight loss from baseline and to maintain at least 20 weight loss from baseline The intensive medical treatment is compared to a usual care treatment model where individuals utilize self directed approaches to weight loss The active treatment period is three years followed by two years of observation
Detailed Description:
LOSS is a pragmatic clinical trial designed to evaluate intensive medical treatment for patients with severe obesity who would otherwise qualify as candidates for obesity surgery and who are covered by the Louisiana Office of Group Benefits OGB Health Insurance LOSS will track the efficacy safety and costs to compare two patient management approaches - intensive medical treatment or a usual medical care treatment model Recruitment will be done by mailers to insured patients to identify eligible candidates We will randomly assign eligible volunteers to intensive medical treatment n240 or usual care n240 Patients will be evaluated annually and medical treatments are given in eight clinics around Louisiana The eight sites are in Alexandria Baton Rouge Lafayette Lake Charles Monroe Hammond New Orleans and Shreveport
Hypothesis
We hypothesize that we can achieve weight loss after two and five years that exceeds 20 from baseline with intensive medical management of persons with class III obesity and that this weight loss is greater than that achieved with usual medical care including access to a weight management web site
Our secondary hypotheses are 1 that the weight loss at year 2 and 5 in the intensive medical group is associated with improvements in blood pressure fasting glucose lipids health-related quality of life and psychosocial measures and is greater improvement than that achieved with usual medical care and access to a website and 2 that total medical costs in the intensive medical management group will compare favorably to total medical costs in the usual care group ie total reimbursement from insurance costs will be less even when the expense of the treatment is considered
Overall Aim
The overarching aim of this study is to observe the effect of an intensive medical management program versus usual care for class III obesity on weight loss total medical costs and on measures of health risks associated with weight loss blood pressure blood glucose blood lipids and health-related quality of life
Specific Aims
Primary The primary specific aim of the LOSS study is to test the hypothesis that the weight loss efficacy at years 2 and 5 for an intensive medical treatment program for Class III obesity produces greater weight loss as compared to a condition of usual care
Secondary The secondary aims of the study are
To evaluate the percent change in body weight absolute change in body weight kilograms and percent excess weight lost from baseline at months 3 6 12 24 36 48 and 60 for medically treated patient groups and at years 1 2 3 4 and 5 for both groups
To evaluate the number and proportion of subjects who maintain 100 and 80 of 12 months weight lost at months 24 36 48 and 60 for medically treated patients and at years 2 3 4 and 5 for both groups
To evaluate the changes from baseline in blood pressure pulse rate and efficacy laboratory parameters at visits on months 3 6 12 24 36 48 and 60 for the medically treated patient group and at years 1 2 3 4 and 5 for both groups
To assess the safety and tolerability of the intervention regimens at months 3 6 12 24 36 48 and 60 for the medically treated patient group
To assess the total medical costs of the participants treated with intensive medical treatment and for the patients receiving usual care at years 1 2 3 4 and 5
To assess additional psychosocial and economic measures health-related quality of life pain depression and stress for the intervention group at months 4 8 12 24 36 48 and 60 months for both groups at years 1 2 3 4 and 5
To compare subgroups of patients with class III obesity to determine if differences in outcome exist for gender race education level decades of age and presence of co-morbid conditions
The Pennington Biomedical Research Center is the lead institution for the project Pennington Management of Clinical Trials PMCT will serve as the Coordinating Center to manage enrollment and data acquisition and will report all data of health and cost results to a Data Safety Monitoring Board on a regular basis Major data reports and scientific publications occur at years 2 and 5
Hypothesis
We hypothesize that we can achieve weight loss after two and five years that exceeds 20 from baseline with intensive medical management of persons with class III obesity and that this weight loss is greater than that achieved with usual medical care including access to a weight management web site
Our secondary hypotheses are 1 that the weight loss at year 2 and 5 in the intensive medical group is associated with improvements in blood pressure fasting glucose lipids health-related quality of life and psychosocial measures and is greater improvement than that achieved with usual medical care and access to a website and 2 that total medical costs in the intensive medical management group will compare favorably to total medical costs in the usual care group ie total reimbursement from insurance costs will be less even when the expense of the treatment is considered
Overall Aim
The overarching aim of this study is to observe the effect of an intensive medical management program versus usual care for class III obesity on weight loss total medical costs and on measures of health risks associated with weight loss blood pressure blood glucose blood lipids and health-related quality of life
Specific Aims
Primary The primary specific aim of the LOSS study is to test the hypothesis that the weight loss efficacy at years 2 and 5 for an intensive medical treatment program for Class III obesity produces greater weight loss as compared to a condition of usual care
Secondary The secondary aims of the study are
To evaluate the percent change in body weight absolute change in body weight kilograms and percent excess weight lost from baseline at months 3 6 12 24 36 48 and 60 for medically treated patient groups and at years 1 2 3 4 and 5 for both groups
To evaluate the number and proportion of subjects who maintain 100 and 80 of 12 months weight lost at months 24 36 48 and 60 for medically treated patients and at years 2 3 4 and 5 for both groups
To evaluate the changes from baseline in blood pressure pulse rate and efficacy laboratory parameters at visits on months 3 6 12 24 36 48 and 60 for the medically treated patient group and at years 1 2 3 4 and 5 for both groups
To assess the safety and tolerability of the intervention regimens at months 3 6 12 24 36 48 and 60 for the medically treated patient group
To assess the total medical costs of the participants treated with intensive medical treatment and for the patients receiving usual care at years 1 2 3 4 and 5
To assess additional psychosocial and economic measures health-related quality of life pain depression and stress for the intervention group at months 4 8 12 24 36 48 and 60 months for both groups at years 1 2 3 4 and 5
To compare subgroups of patients with class III obesity to determine if differences in outcome exist for gender race education level decades of age and presence of co-morbid conditions
The Pennington Biomedical Research Center is the lead institution for the project Pennington Management of Clinical Trials PMCT will serve as the Coordinating Center to manage enrollment and data acquisition and will report all data of health and cost results to a Data Safety Monitoring Board on a regular basis Major data reports and scientific publications occur at years 2 and 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None