An Internet-based Behavioral Weight Loss Program for HIV+ Patients
- Conditions
- OverweightHIVObesity
- Interventions
- Behavioral: Internet Education InterventionBehavioral: Internet Behavioral Intervention
- Registration Number
- NCT02421406
- Lead Sponsor
- The Miriam Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Recruited from the Miriam Hospital Immunology Center
- HIV+ with a CD4 count >200 and an undetectable viral load
- BMI greater than 27 kg/m2
- No health problems that make weight loss or unsupervised exercise unsafe
- English speaking
- Have access to a computer and the Internet
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire
- Active substance abuser
- Currently pregnant or intend to become pregnant in the next 6 months
- Planning to move outside of the state within the next 6 months
- Have participated in a study conducted by the Weight Control & Diabetes Research Center in the past 2 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Internet Education Intervention Internet Education Intervention Participants receive 12 weekly Internet-based weight loss lessons containing information for modification of diet and activity behaviors, but not behavioral strategies for changing these behaviors. Internet Behavioral Intervention Internet Behavioral Intervention Participants receive a 12-week Internet-based eating and activity intervention including multimedia lessons and enhanced self-monitoring of weight loss behaviors with automated feedback
- Primary Outcome Measures
Name Time Method Weight 12 weeks
- Secondary Outcome Measures
Name Time Method Physical activity assessed by objective monitoring of activity 12 weeks Objective physical activity measured using SenseWear Mini armband and self-reported physical activity measured using the International Physical Activity Questionnaire short form.
Lipid profile assessed by analysis of fasting blood work 12 weeks Lipids (total cholesterol, HDL, LDL, triglycerides) measured using blood samples taken in fasting state.
Diet assessed by 24-hour recalls 12 weeks Dietary intake patterns measured using a three-day diet record.
Inflammatory profile assessed by analysis of fasting blood work 12 weeks IL-6, C-reactive protein, adiponectin measured using blood samples taken in fasting state.
Metabolic profile assessed by analysis of fasting blood work 12 weeks Fasting blood sugar and insulin measured using blood samples taken in fasting state.