Clinical trial NCT02421406: An Internet-based Behavioral Weight Loss Program for HIV+ Patients
Official title: An Internet-based Behavioral Weight Loss Program for HIV+ Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
HIV
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2015-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: 12 weeks
Secondary outcomes:
measure: Diet assessed by 24-hour recalls
timeFrame: 12 weeks
measure: Physical activity assessed by objective monitoring of activity
timeFrame: 12 weeks
measure: Metabolic profile assessed by analysis of fasting blood work
timeFrame: 12 weeks
measure: Lipid profile assessed by analysis of fasting blood work
timeFrame: 12 weeks
measure: Inflammatory profile assessed by analysis of fasting blood work
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Wing RR, Becofsky K, Wing EJ, McCaffery J, Boudreau M, Evans EW, Unick J. Behavioral and Cardiovascular Effects of a Behavioral Weight Loss Program for People Living with HIV. AIDS Behav. 2020 Apr;24(4):1032-1041. doi: 10.1007/s10461-019-02503-x.
citation: Becofsky K, Wing EJ, McCaffery J, Boudreau M, Wing RR. A Randomized Controlled Trial of a Behavioral Weight Loss Program for Human Immunodeficiency Virus-Infected Patients. Clin Infect Dis. 2017 Jul 1;65(1):154-157. doi: 10.1093/cid/cix238.