An Internet-based Behavioral Weight Loss Program for HIV+ Patients

Obesity Clinical Trial

Official title: An Internet-based Behavioral Weight Loss Program for HIV+ Patients

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• HIV
• Obesity
• Overweight
• Weight Loss

• NCT number: NCT02421406
• Study type: Interventional
• Source: The Miriam Hospital
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Completion date: February 2017