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

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ClinicalTrials.gov Identifier: NCT02421406
Recruitment Status : Completed
First Posted : April 20, 2015
Last Update Posted : April 7, 2017
Sponsor:
Collaborators:
Brown University
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Overweight Obesity HIV Behavioral: Internet Behavioral Intervention Behavioral: Internet Education Intervention Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Internet-based Behavioral Weight Loss Program for HIV+ Patients
Study Start Date : May 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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
Behavioral: Internet Behavioral Intervention
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.
Active Comparator: 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.
Behavioral: Internet Education Intervention
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.



Primary Outcome Measures :
  1. Weight [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Diet assessed by 24-hour recalls [ Time Frame: 12 weeks ]
    Dietary intake patterns measured using a three-day diet record.

  2. Physical activity assessed by objective monitoring of activity [ Time Frame: 12 weeks ]
    Objective physical activity measured using SenseWear Mini armband and self-reported physical activity measured using the International Physical Activity Questionnaire short form.

  3. Metabolic profile assessed by analysis of fasting blood work [ Time Frame: 12 weeks ]
    Fasting blood sugar and insulin measured using blood samples taken in fasting state.

  4. Lipid profile assessed by analysis of fasting blood work [ Time Frame: 12 weeks ]
    Lipids (total cholesterol, HDL, LDL, triglycerides) measured using blood samples taken in fasting state.

  5. Inflammatory profile assessed by analysis of fasting blood work [ Time Frame: 12 weeks ]
    IL-6, C-reactive protein, adiponectin measured using blood samples taken in fasting state.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT02421406     History of Changes
Other Study ID Numbers: 2P30AI042853-16 ( U.S. NIH Grant/Contract )
P30AI042853 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes