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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
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

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

    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)
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    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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