LOSS- Louisiana Obese Subjects Study

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00115063
• Collaborator: Louisiana Office of Group Benefits (Other)
• Enrollment: 390
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 13

Study Details

Study Description

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 kg/m2). 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: group sessions; Drug: sibutramine, orlistat, diethylpropion; Behavioral: Low Calorie Diet, Health One; Other: Intensive Medical Combination Therapy for Obesity; Other: Control Condition	Phase 4

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 (n=240) or usual care (n=240). 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 (i.e., 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 Design

• Study Type: Interventional
• Actual Enrollment: 390 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Loss - Louisiana Obese Subjects Study
• Study Start Date: Jul 1, 2005
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a "Tool Box" approach	Behavioral: group sessions; group sessions lead by a trained primary care clinic employee; Drug: sibutramine, orlistat, diethylpropion; dosage modified according to package insert instructions at discretion of primary care physicians; Behavioral: Low Calorie Diet, Health One; liquid diet for 8-12 weeks to induce weight loss; Other: Intensive Medical Combination Therapy for Obesity; Very Low Calorie Liquid diet, Group Behavioral Therapy, Meal Replacement Therapy, Obesity Pharmacotherapy and a "Treatment Toolbox".
Active Comparator: 2 Access to Weight Loss Informational Website sponsored by the Mayo Clinic	Other: Control Condition; Access to the Mayo Clinic weight management website and usual care from the primary care physician

Outcome Measures

Primary Outcome Measures

1. Percent Change From Baseline Weight [Baseline, 2 years]

Secondary Outcome Measures

1. Change in Weight From Baseline in Kilograms (kg) [Baseline, 2 years]

2. Change in Blood Pressure [Baseline, 2 years]

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

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

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participant in the Exclusive Provider Organization (EPO), Managed Care Organization (MCO) and Preferred Provider Organization (PPO) programs of the Louisiana State Employees Group Benefits Health Insurance

• Agree to travel for treatment to the assigned study site

• Agree to randomized treatment assignment

• Male and females age 20-60 years

• Body Mass Index >40kg/m2 but < 60 kg/m2

• Females must be non-pregnant and using an approved contraception method

• Complete Blood Count (CBC): normal hematocrit, white count and platelet count, unless waived by Principal Investigator (PI)

• Uric Acid <9.0 mg/dl

• Normal Creatinine

• Normal Thyroid Stimulating Hormone (TSH)

• Negative urine pregnancy test for women of childbearing potential

• Able to give written informed consent

• Able to comply with study procedures

Exclusion Criteria:

Factors that may limit adherence to interventions or affect conduct of the trial:

• Unable or unwilling to give informed consent or communicate with local study staff

• Hospitalization for psychiatric illness or substance use/abuse within the past year

• Self-report of alcohol or substance abuse within the past twelve months

• Current major depressive episode or history of suicidal behaviors

• Endorsement of significant recent suicidal ideation (as determined by PI)

• Travel plans that do not permit participation

• History of prior bariatric surgery, small bowel resection, or extensive bowel resection

• Current use of chronic systemic corticosteroids, appetite suppressants, antipsychotic medication, herbal medications for weight loss or any medication not approved by the PI.

• Another member of the household is a participant or staff member in the study

• History of eating disorder such as anorexia nervosa, bulimia, or binge eating

• Diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, or personality disorder (as determined by the PI)

• Currently pregnant or nursing or plans to become pregnant in the next five years

• Except for non-melanoma skin cancer, cancer requiring treatment in the past five years, unless the prognosis is excellent

• Self report of Human Immunodeficiency Virus (HIV) positive, hepatitis C or active tuberculosis

• Cardiovascular disease event within the past year

• Severe congestive heart failure (New York Heart Association [NYHA] Functional Class III, IV)

• Second degree or greater heart block

• Blood Pressure >160 systolic or >100 diastolic on two consecutive visits, unless treated and re-screened

• Based upon responses to psychological screening or an interview, patients may be excluded by the study psychologist.

• Other medical, psychiatric, or behavioral limitations that in the judgment of the investigator may interfere with study participation or the ability to follow the intervention protocol.

• Pregnancy is to be avoided during the study. Women who have not had a hysterectomy or oophorectomy must have a negative urine pregnancy test result at screening. Women of childbearing potential will be allowed to participate if they have undergone tubal ligation, or use one of the following types of contraception: properly used condom or diaphragm, oral contraceptives, hormonal implant, or intrauterine device (IUD). Sexual abstinence may constitute an acceptable birth control method for this study with investigator approval. Women with male partners who have had a successful vasectomy (more than one year of unprotected sexual intercourse without pregnancy) are not required to use additional birth control methods as long as the relationship remains exclusive, and the woman agrees to use an approved contraception method with any other male partner. Questions regarding individual patient contraceptive practices should be directed to the Principal Investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Management of Clinical Trials	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

• Pennington Biomedical Research Center
• Louisiana Office of Group Benefits

Investigators

• Principal Investigator: Donna H Ryan, MD, Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Pennington Biomedical Research Center home page

Publications

None provided.

• Responsible Party: Donna H. Ryan, MD, Professor, Adjunct, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT00115063
• Other Study ID Numbers: PBRC 25002
• First Posted: Jun 21, 2005
• Last Update Posted: Feb 22, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Donna H. Ryan, MD, Professor, Adjunct, Pennington Biomedical Research Center: obesity; Low Calorie Diet; Obesity Pharmacotherapy; Pragmatic Clinical Trial
• Additional relevant MeSH terms: Obesity; Orlistat; Sibutramine; Diethylpropion

Study Results

Participant Flow

Arm/Group Title	Intensive Medical Intervention	Access to Weight Loss Informational Website
Arm/Group Description	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 sponsored by the Mayo Clinic
Period Title: Overall Study
STARTED	200	190
COMPLETED	101	86
NOT COMPLETED	99	104

Baseline Characteristics

Arm/Group Title	Intensive Medical Intervention	Access to Weight Loss Informational Website	Total
Arm/Group Description	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 sponsored by the Mayo Clinic	Total of all reporting groups
Overall Participants	200	190	390
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	200 100%	190 100%	390 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.2 (0.6)	47.1 (0.6)	47.2 (0.6)
Sex: Female, Male (Count of Participants)
Female	167 83.5%	159 83.7%	326 83.6%
Male	33 16.5%	31 16.3%	64 16.4%
Race/Ethnicity, Customized (participants) [Number]
Hispanic or Latino	1 0.5%	0 0%	1 0.3%
White	149 74.5%	147 77.4%	296 75.9%
Black or African American	50 25%	43 22.6%	93 23.8%
Region of Enrollment (participants) [Number]
United States	200 100%	190 100%	390 100%

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline Weight
Time Frame	Baseline, 2 years

Outcome Measure Data

Analysis Population Description

This analysis was done on the completers, those that completed the 2 year study visit.

Arm/Group Title	Intensive Medical Intervention	Access to Weight Loss Informational Website
Arm/Group Description	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 sponsored by the Mayo Clinic
Measure Participants	101	86
Mean (Standard Error) [Percent change]	-9.7 (1.3)	-0.4 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intensive Medical Intervention, Access to Weight Loss Informational Website
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Change in Weight From Baseline in Kilograms (kg)
Time Frame	Baseline, 2 years

Outcome Measure Data

Analysis Population Description

This analysis was done on the completers, those that completed the 2 year study visit.

Arm/Group Title	Intensive Medical Intervention	Access to Weight Loss Informational Website
Arm/Group Description	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 sponsored by the Mayo Clinic
Measure Participants	101	86
Mean (Standard Error) [kg]	-12.7 (1.7)	-0.5 (0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intensive Medical Intervention, Access to Weight Loss Informational Website
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Change in Blood Pressure
Time Frame	Baseline, 2 years

Outcome Measure Data

Analysis Population Description

This analysis was done on the completers, those that completed the 2 year study visit.

Arm/Group Title	Intensive Medical Intervention	Access to Weight Loss Informational Website
Arm/Group Description	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 sponsored by the Mayo Clinic
Measure Participants	101	86
systolic blood pressure	-14.7 (2.4)	-8.6 (2.6)
dystolic blood pressure	-4.4 (1.8)	-3.2 (1.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intensive Medical Intervention, Access to Weight Loss Informational Website
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.09
	Comments	P-value for systolic blood pressure mean.
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intensive Medical Intervention, Access to Weight Loss Informational Website
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.60
	Comments	P-value for dystolic blood pressure mean.
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This analysis was done on the completers, those that completed the 2 year study visit.

Arm/Group Title	Intensive Medical Intervention	Access to Weight Loss Informational Website
Arm/Group Description	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 sponsored by the Mayo Clinic
Measure Participants	101	86
LDL	1.8 (2.4)	0.7 (2.4)
HDL	7.9 (1.8)	1.5 (1.8)
Triglycerides	-9.2 (3.5)	-4.8 (4.3)
Uric Acid	-3.0 (2.4)	3.1 (1.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intensive Medical Intervention, Access to Weight Loss Informational Website
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.73
	Comments	P-value for LDL cholesterol
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intensive Medical Intervention, Access to Weight Loss Informational Website
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments	P-value for HDL cholesterol
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intensive Medical Intervention, Access to Weight Loss Informational Website
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.42
	Comments	P-value for triglycerides
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Intensive Medical Intervention, Access to Weight Loss Informational Website
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments	P-value for uric acid
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This analysis was done on the completers, those that completed the 2 year study visit.

Arm/Group Title	Intensive Medical Intervention	Access to Weight Loss Informational Website
Arm/Group Description	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 sponsored by the Mayo Clinic
Measure Participants	101	86
Mean (Standard Error) [mg/dL]	2.4 (2.1)	6.7 (2.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intensive Medical Intervention, Access to Weight Loss Informational Website
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.16
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	Change in Duke Activity Status Index (DASI) Questionnaire Score
Description	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.
Time Frame	Baseline, 2 years

Outcome Measure Data

Analysis Population Description

This analysis was done on the completers, those that completed the 2 year study visit.

Arm/Group Title	Intensive Medical Intervention	Access to Weight Loss Informational Website
Arm/Group Description	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 sponsored by the Mayo Clinic
Measure Participants	101	86
Mean (Standard Error) [units on a scale]	-2.1 (1.7)	-11.6 (2.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intensive Medical Intervention, Access to Weight Loss Informational Website
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Serious adverse events were collected at all study visits for both groups from study start to 2 years.
Adverse Event Reporting Description	Only serious adverse events were tracked for this study.
Arm/Group Title	Intensive Medical Intervention		Access to Weight Loss Informational Website
Arm/Group Description	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 sponsored by the Mayo Clinic
All Cause Mortality
	Intensive Medical Intervention		Access to Weight Loss Informational Website
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intensive Medical Intervention		Access to Weight Loss Informational Website
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/200 (10%)		8/190 (4.2%)
Cardiac disorders
Chest heaviness	1/200 (0.5%)	1	0/190 (0%)	0
Elevated blood pressure and mood swings	1/200 (0.5%)	1	0/190 (0%)	0
Chest pain	2/200 (1%)	2	0/190 (0%)	0
Death	1/200 (0.5%)	1	0/190 (0%)	0
New-onset atrial fibrillation	1/200 (0.5%)	1	0/190 (0%)	0
Hospitalization for acute myocardial infarction	0/200 (0%)	0	1/190 (0.5%)	1
Gastrointestinal disorders
Hernia repair	2/200 (1%)	2	0/190 (0%)	0
Bleeding duodenal ulcer	1/200 (0.5%)	1	0/190 (0%)	0
Metabolism and nutrition disorders
Hospitalization for hypokalemia	0/200 (0%)	0	1/190 (0.5%)	1
Musculoskeletal and connective tissue disorders
Hospitalization for arm fracture	1/200 (0.5%)	1	0/190 (0%)	0
Cervical disk surgery	1/200 (0.5%)	1	0/190 (0%)	0
Hospitalization for back surgery	0/200 (0%)	0	1/190 (0.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	0/200 (0%)	0	1/190 (0.5%)	1
Psychiatric disorders
Hospitalization for hallucinations	1/200 (0.5%)	1	0/190 (0%)	0
Renal and urinary disorders
Surgery for cyctocele	1/200 (0.5%)	1	0/190 (0%)	0
Hospitalization for nephrolithiasis	1/200 (0.5%)	1	0/190 (0%)	0
Reproductive system and breast disorders
Hysterectomy	0/200 (0%)	0	1/190 (0.5%)	1
Respiratory, thoracic and mediastinal disorders
Hospitalization for pneumonia	1/200 (0.5%)	1	0/190 (0%)	0
Hospitalization for asthma and bronchitis	1/200 (0.5%)	1	0/190 (0%)	0
Surgical and medical procedures
Surgical incision and drainage of abscess	1/200 (0.5%)	1	0/190 (0%)	0
Pacemaker insertion procedure	0/200 (0%)	0	1/190 (0.5%)	1
Hospitalization for stent placement	0/200 (0%)	0	1/190 (0.5%)	1
Vascular disorders
Hospitalization for coronary stent replacement	1/200 (0.5%)	1	0/190 (0%)	0
Hospitalization for deep vein thrombosis	1/200 (0.5%)	1	0/190 (0%)	0
Other (Not Including Serious) Adverse Events
	Intensive Medical Intervention		Access to Weight Loss Informational Website
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/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.

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.