HIVNCT00111358
Study of Lifestyle Modification in HIV Lipodystrophy
A study testing Lifestyle Modification and No lifestyle modification in people with HIV and Metabolic Diseases, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV, Metabolic Diseases
- What is being tested?
- Lifestyle Modification and No lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Oct 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 and less than or equal to 65 years of age
- HIV+
- Ability and motivation to modify behavior and make lifestyle changes
- 3 out of 5 of the following:
- Waist circumference greater than 102 cm (40 in) in men and 88 cm (35 in) in women;
- Triglycerides greater than or equal to 150 mg/dL or current anti-lipolytic drug treatment;
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- High-density lipoprotein (HDL) less than 40 mg/dL in men and 50 mg/dL in women;
- Blood pressure greater than or equal to 130/85 mmHg or current antihypertensive drug treatment;
- Fasting glucose greater than or equal to 110 mg/dL.
Who cannot join
- History of unstable angina, aortic stenosis, uncontrolled hypertension, severe neuropathy, arthritis or other contraindication to exercise
- Requiring pharmacological glucocorticoid therapy (> 7.5mg Prednisone or its equivalent/day)
- Androgen, growth hormone or Megace within 3 months of study initiation. Subjects on a standard dose of testosterone for documented hypogonadism for > 3 months will be allowed to enter the study.
- New anti-retroviral therapy within 1 month of study initiation
- SGPT > 5X normal and/or clinically significant liver disease
- Creatinine > 2.0 mg/dL and/or clinically significant renal disease
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- Hemoglobin (Hgb) < 9 g/dL
- Current drug or alcohol abuse
- History of diabetes mellitus or fasting glucose of greater than or equal to 126 mg/dL
- Current therapy with insulin or other diabetic agent
- Pregnant or actively seeking pregnancy
- Breastfeeding
- Inability to comply with intervention due to lack of motivation, time, social, and/or psychological support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Lifestyle Modification Program (REACH) in Patients With HIV and Metabolic Syndrome
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.
Read the detailed description
This study is designed as a randomized, case-control study of 80 subjects (N=80). 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 mg/dL.
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 investigator/co-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.
- Conditions
- HIV, Metabolic Diseases
- Being tested
- Lifestyle Modification, No lifestyle modification
- Keywords
- HIV, AIDS, metabolic syndrome
- Medical subject headings
- Metabolic Diseases, Acquired Immunodeficiency Syndrome, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ModificationBehavioural
No lifestyle modificationOther
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Modification | Active comparator | 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. Receives: Behavioral: Lifestyle Modification |
| Control | Placebo comparator | Not described Receives: Other: No lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHR
Secondary outcomes (10)
total cholesterol
LDL
HDL
triglyceride cholesterol levels
blood pressure
cardiac enzymes
CRP
t-PA
PAI
insulin and glucose metabolism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2005 (estimated)
- Study startJun 2003
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Steven Grinspoon, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111358
- Sponsor's protocol ID
- 49302-P1 (completed)
- Other IDs
- R01DK049302
- Status last verified
- Apr 2011
- First submitted
- 19 May 2005
- Last updated
- 18 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Lifestyle Modification Program (REACH) in Patients With HIV and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00111358
- Acronym / sponsor ID
- 49302-P1 (completed)
- Conditions
- HIV, Metabolic Diseases
- Keywords
- HIV, AIDS, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jun 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 20 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (N=80). 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 mg/dL.
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 investigator/co-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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Modification | Active comparator | Behavioral: Lifestyle ModificationGoals 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. |
| Control | Placebo comparator | Other: No lifestyle modification |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age greater than or equal to 18 and less than or equal to 65 years of age
- HIV+
- Ability and motivation to modify behavior and make lifestyle changes
- 3 out of 5 of the following:
Key exclusion criteria (13 listed)
- History of unstable angina, aortic stenosis, uncontrolled hypertension, severe neuropathy, arthritis or other contraindication to exercise
- Requiring pharmacological glucocorticoid therapy (> 7.5mg Prednisone or its equivalent/day)
- Androgen, growth hormone or Megace within 3 months of study initiation. Subjects on a standard dose of testosterone for documented hypogonadism for > 3 months will be allowed to enter the study.
- New anti-retroviral therapy within 1 month of study initiation
- SGPT > 5X normal and/or clinically significant liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Modification | Behavioural | Lifestyle Modification |
| No lifestyle modification | Other | Control |
Primary outcome
WHR
10 secondary outcomes
total cholesterol
LDL
HDL
triglyceride cholesterol levels
blood pressure
cardiac enzymes
CRP
t-PA
PAI
insulin and glucose metabolism
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Grinspoon, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Modification and No lifestyle modification in people with HIV and Metabolic Diseases, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHR. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2011.