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临床试验/NCT03790501
NCT03790501Unknown不适用

Impact of Physical Activity Routines and Dietary Intake on the Longitudinal Symptom Experience of People Living With HIV

University of Washington4 个研究点 分布在 1 个国家目标入组 850 人开始时间: 2019年1月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
850
试验地点
4
主要终点
Symptom Distress

研究概览

简要总结

We will conduct a four-year, observational study of 850 participants to measure physical activity and diet, once a year for three years. All participants will also complete the standard Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) patient-reported outcomes (PRO) and clinical assessment procedures. An enhanced PRO assessment (consisting measures of physical activity, diet intake and anthropomorphic factors) will be included after the routine patient clinic visit at four CNICS sites: Case Western Reserve University, University of Alabama at Birmingham, University of Washington, and Fenway Health.

详细描述

PROSPER-HIV is a four-year, prospective, observational study of 850 CNICS participants who will complete an enhanced patient-reported outcome (PRO) assessment to measure physical activity and diet intake, once a year for three years. All participants will also complete the standard CNICS PRO and clinical assessment procedures. We propose to integrate the following measures, physical activity (triaxial accelerometery), dietary intake (24-hour diet recalls), and anthropomorphic factors (waist-hip-ratio), into an enhanced annual assessment of patient reported outcomes at four CNICS sites: Case Western Reserve University, University of Alabama at Birmingham, University of Washington, and Fenway Health. Our four primary objectives are to:

  1. Identify and characterize longitudinal, objectively measured, physical activity and dietary patterns among PLHIV
  2. Examine the relationship between objectively-measured physical activity and self-reported physical activity on the Lipid Research Clinics Physical Activity Questionnaire.
  3. Determine which aspects of physical activity patterns and diet quality are associated with decreased symptom burden and intensity in PLHIV, and if this relationship is moderated by age and sex.
  4. Explore the potential mediating effect of anthropomorphic and physical fitness variables on the relationships between physical activity, dietary patterns, and symptom burden and intensity in PLHIV.

We hypothesize that people living with HIV who 1) have more intense, frequent and longer physical activity bouts will have age- and sex-dependent reduced symptom burden; 2) eat better quality diets (e.g., more fiber and protein, fewer carbohydrates) will have reduced symptom burden and intensity and that this relationship will also vary by age and sex.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Be an active CNICS participant
  • aged ≥18 years
  • prescribed HIV antiretroviral therapy, and
  • have an undetectable HIV viral load: defined as the most recent HIV viral load <200 copies/mL, checked within the past year.

排除标准

  • Did not complete the HIV Symptom Index in the PRO assessment (2) No reliable access to a telephone or internet-enable telephone services needed to complete the 24-diet recalls (3) Was pregnant, breast-feeding, or planning a pregnancy at the time of PRO assessment (4) Planning to move out of the area in the next 36 months, or (5) Non-English speaking.

结局指标

主要结局

Symptom Distress

时间窗: Four years

Symptom distress will be measured with the-20 item HIV Symptom Index. As recommended, our primary endpoints include 1) total symptom count (sum all symptoms that are reported as having the symptom and it bothers the participant at least a little); and 2) a total count of symptoms that bother the participant a lot (high symptom distress).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Allison Webel

Assistant Professor

University of Washington

研究点 (4)

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