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临床试验/NCT02421406
NCT02421406已完成不适用

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

The Miriam Hospital0 个研究点目标入组 50 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
Weight

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Weight

时间窗: 12 weeks

次要结局

  • Physical activity assessed by objective monitoring of activity(12 weeks)
  • Lipid profile assessed by analysis of fasting blood work(12 weeks)
  • Diet assessed by 24-hour recalls(12 weeks)
  • Inflammatory profile assessed by analysis of fasting blood work(12 weeks)
  • Metabolic profile assessed by analysis of fasting blood work(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

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