Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111358
Status:
COMPLETED
Last Update Posted:
2011-04-18
First Post:
2005-05-19
Brief Title:
Study of Lifestyle Modification in HIV Lipodystrophy
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
The Effects of a Lifestyle Modification Program REACH in Patients With HIV and Metabolic Syndrome
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
This study is designed as a randomized case-control study of 80 subjects N80 Forty subjects will be randomized to the observation group and 40 to the intervention REACH group
After two initial screening visits with medical and nutrition staff for informed consent determination of eligibility and evaluation of a 7-day food record qualifying patients will be seen for a baseline visit A nutrition questionnaire and bioimpedance analysis BIA testing will be done at the first screening visit and sub-maximal stress testing and other tests with physical therapy will be done at the second screening visit
At baseline patients will have an interval history and physical exam lipodystrophy evaluation by the investigator objective and patient subjective report blood tests and body composition
Nearly identical visits to that at baseline with the addition of the sub-maximal stress test and other physical therapy testing will be repeated at 6 and 12 months Carotid ultrasound will be repeated at the 6 and 12 month visits There will also be a short visit at 3 and 9 months to obtain an interval history and physical exam safety labs and a 7-day food record for an Intake Report
At baseline patients will be randomized to either the observation group or the lifestyle intervention known as Reach for Energy Activity and Cardiovascular Health REACH Randomization will be stratified for gender and fasting glucose or 110 mgdL
Those randomized to observation will receive a one time counseling session with nutrition staff at the baseline visit and monthly unscripted phone calls from the investigatorco-investigator and come in for regular study visits at 3 6 9 and 12 months as described above
Those randomized to REACH will attend one-on-one counseling sessions with a trained dietitian covering the core-curriculum that is modeled after the Diabetes Prevention Program DPP study 16 week core curriculum intervention
After two initial screening visits with medical and nutrition staff for informed consent determination of eligibility and evaluation of a 7-day food record qualifying patients will be seen for a baseline visit A nutrition questionnaire and bioimpedance analysis BIA testing will be done at the first screening visit and sub-maximal stress testing and other tests with physical therapy will be done at the second screening visit
At baseline patients will have an interval history and physical exam lipodystrophy evaluation by the investigator objective and patient subjective report blood tests and body composition
Nearly identical visits to that at baseline with the addition of the sub-maximal stress test and other physical therapy testing will be repeated at 6 and 12 months Carotid ultrasound will be repeated at the 6 and 12 month visits There will also be a short visit at 3 and 9 months to obtain an interval history and physical exam safety labs and a 7-day food record for an Intake Report
At baseline patients will be randomized to either the observation group or the lifestyle intervention known as Reach for Energy Activity and Cardiovascular Health REACH Randomization will be stratified for gender and fasting glucose or 110 mgdL
Those randomized to observation will receive a one time counseling session with nutrition staff at the baseline visit and monthly unscripted phone calls from the investigatorco-investigator and come in for regular study visits at 3 6 9 and 12 months as described above
Those randomized to REACH will attend one-on-one counseling sessions with a trained dietitian covering the core-curriculum that is modeled after the Diabetes Prevention Program DPP study 16 week core curriculum intervention
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK049302 | NIH | None | httpsreporternihgovquickSearchR01DK049302 |