An Internet-based Behavioral Weight Loss Program for HIV+ Patients
Condition: Overweight; Obesity; HIV
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The goal of this project is to determine whether an Internet-based weight loss program will
      lead to weight loss and improvements in cardiovascular disease risk factors in people living
      with HIV.
    

Detailed description: 
      The goal of this project is to provide an empirically validated weight loss program to HIV+
      patients and evaluate its efficacy for weight loss and improvements in cardiovascular disease
      risk factors. Investigators will conduct a randomized pilot study with 50 overweight or obese
      patients who are HIV+, are recruited from the Miriam Hospital Immunology Center, and are
      interested in losing weight. These patients will be randomly assigned to a 12 week behavioral
      weight loss program delivered via the Internet or to a 12 week education only control group
      (also Internet based). Primary aims of this study are 1) to determine whether an Internet
      program is appropriate for this patient population, assessed by the success of recruiting 50
      patients for the trial and their level of adherence over the 12 weeks, 2) to compare weight
      losses at the end of the 12 week program for program for patients randomized to the Internet
      behavioral weight reduction program (WT LOSS) relative to the Internet education program
      (CONTROL), 3) to compare the efficacy of the WT LOSS program relative to CONTROL for
      improving lipids (total cholesterol, HDL, LDL, triglycerides), metabolic measures (fasting
      blood sugar, insulin), and inflammatory markers (IL-6, C-reactive protein, adiponectin), and
      4) to compare the changes in dietary intake and physical activity from baseline to 12 weeks
      in the WT LOSS and CONTROL conditions. Investigators will also store blood for later analysis
      of other adipokines (leptin) and biomarkers of microbial gut translocation (e.g., sCD14).
      These will provide important pilot data for future NIH funding related to both the
      implementation of weight loss programs and the effect of weight loss on the co-morbidities in
      this population.
    

Intervention name(s): Internet Behavioral Intervention; Internet Education Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A series of 12 multi-media lessons will be accessible to participants on their own computers. The lessons (each of which takes about 15 minutes to complete) are based on the Diabetes Prevention Program (DPP) and Look AHEAD. Participants will be taught to record their weight, the calories and the fat grams in each food item, and their physical activity (in minutes) on a daily basis. At the end of the week, they will submit their self-monitored information to the study website and receive an automated feedback message about their progress to date. The lessons will also present key behavior change strategies such as cognitive restructuring, problem solving and relapse prevention.; A series of 12 lessons will be accessible to participants on their own computers. Participants will be given information about normal, overweight and obese categories of body mass index, and provided information on the health problems that are associated with being overweight and the benefits of weight loss for treating and preventing such problems. General information about healthy eating will be provided. Participants will be educated about the benefits of increasing their physical activity, and strategies for increasing activity safely.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment