Study of Lifestyle Modification in HIV Lipodystrophy
Condition: HIV; Metabolic Diseases
MeSH terms: Metabolic Diseases
Study type: Interventional

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 (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.
    

Intervention name(s): Lifestyle Modification; No lifestyle modification
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV, AIDS, metabolic syndrome