NCT00111358|Completed
Study of Lifestyle Modification in HIV Lipodystrophy
The Effects of a Lifestyle Modification Program (REACH) in Patients With HIV and Metabolic Syndrome
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The Effects of a Lifestyle Modification Program (REACH) in Patients With HIV and Metabolic Syndrome
Sponsor study identifier
Secondary identifiers
NIH
interventional
80
1 country
1
Study Start
June 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2006
Actual (reported)Study Completion
October 2006
Actual (reported)This study is designed to determine the effects of an intensive lifestyle modification program in patients with HIV and Metabolic Syndrome. The primary endpoints will be improvement in body composition, specifically waist-to-hip ratio (WHR). The secondary endpoints will include improvement of cardiovascular indices, such as total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglyceride cholesterol levels, blood pressure, cardiac enzymes, c-reactive protein (CRP), tissue plasminogen activator (t-PA), plasminogen activator inhibitor (PAI), and insulin and glucose metabolism. We expect that quality of life indices and life skills should also improve with the lifestyle modification program.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2003
Date type not reportedThis date has not been verified as actual or estimated.
May 19, 2005
Actual (reported)May 20, 2005
Actual (reported)October 2006
Actual (reported)October 2006
Actual (reported)WHR
total cholesterol
LDL
HDL
triglyceride cholesterol levels
blood pressure
Goals derived from the AACE and NCEP-ATP III guidelines and the Diabetes Prevention Program are as follows: \<35% calories from fat, \< 7% calories from saturated fat, up to 10% calories from polyunsaturated fat, reduction of trans fatty acid intake, up to 20% calories from monounsaturated fat, and 25-35g of fiber per day. 3 hrs of physical activity/week at moderate intensity, \>10,000 steps in daily activity, measured by pedometer. The curriculum is modeled after the Diabetes Prevention Program. Subjects will complete lifestyle sessions in the offices of the Program in Nutritional Metabolism or in the Clinical Research Center at MGH with protocol study staff trained to implement the curriculum.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Mass General Hospital
Boston, Massachusetts, 02114, United States
Steven Grinspoon, MD
Massachusetts General Hospital
First Submitted
May 19, 2005
First Posted
May 20, 2005
Study Start
June 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2006
Actual (reported)Smoking Cessation for HIV/AIDS Patients
Contact the study team to confirm eligibility.
Study Completion
October 2006
Actual (reported)Last Updated
April 18, 2011
Record last verified: 2011-04
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Source: ClinicalTrials.gov.
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