An Internet-based Behavioral Weight Loss Program for HIV+ Patients
Primary Purpose
Overweight, Obesity, HIV
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internet Behavioral Intervention
Internet Education Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Overweight
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Internet Behavioral Intervention
Internet Education Intervention
Arm 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
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.
Outcomes
Primary Outcome Measures
Weight
Secondary Outcome Measures
Diet assessed by 24-hour recalls
Dietary intake patterns measured using a three-day diet record.
Physical activity assessed by objective monitoring of activity
Objective physical activity measured using SenseWear Mini armband and self-reported physical activity measured using the International Physical Activity Questionnaire short form.
Metabolic profile assessed by analysis of fasting blood work
Fasting blood sugar and insulin measured using blood samples taken in fasting state.
Lipid profile assessed by analysis of fasting blood work
Lipids (total cholesterol, HDL, LDL, triglycerides) measured using blood samples taken in fasting state.
Inflammatory profile assessed by analysis of fasting blood work
IL-6, C-reactive protein, adiponectin measured using blood samples taken in fasting state.
Full Information
NCT ID
NCT02421406
First Posted
April 6, 2015
Last Updated
April 6, 2017
Sponsor
The Miriam Hospital
Collaborators
Brown University, National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT02421406
Brief Title
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
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
Collaborators
Brown University, National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, HIV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Internet Behavioral Intervention
Arm Type
Experimental
Arm 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
Arm Title
Internet Education Intervention
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Internet Behavioral Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet Education Intervention
Intervention Description
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 Measure Information:
Title
Weight
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Diet assessed by 24-hour recalls
Description
Dietary intake patterns measured using a three-day diet record.
Time Frame
12 weeks
Title
Physical activity assessed by objective monitoring of activity
Description
Objective physical activity measured using SenseWear Mini armband and self-reported physical activity measured using the International Physical Activity Questionnaire short form.
Time Frame
12 weeks
Title
Metabolic profile assessed by analysis of fasting blood work
Description
Fasting blood sugar and insulin measured using blood samples taken in fasting state.
Time Frame
12 weeks
Title
Lipid profile assessed by analysis of fasting blood work
Description
Lipids (total cholesterol, HDL, LDL, triglycerides) measured using blood samples taken in fasting state.
Time Frame
12 weeks
Title
Inflammatory profile assessed by analysis of fasting blood work
Description
IL-6, C-reactive protein, adiponectin measured using blood samples taken in fasting state.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
31004243
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.
Results Reference
derived
PubMed Identifier
28369269
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.
Results Reference
derived
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An Internet-based Behavioral Weight Loss Program for HIV+ Patients
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