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

Lifespan

Status: Completed

Conditions: Overweight; HIV; Obesity

Treatments: Behavioral: Internet Behavioral Intervention; Behavioral: Internet Education Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02421406

2P30AI042853-16

P30AI042853 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Internet Behavioral Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Internet Behavioral Intervention

Internet Education Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Internet Education Intervention