Impact of Physical Activity and Diet on Symptom Experience in People Living With HIV (PROSPER-HIV)
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|ClinicalTrials.gov Identifier: NCT03790501|
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : January 22, 2020
|Condition or disease||Intervention/treatment|
|HIV/AIDS||Other: No intervention|
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:
- Identify and characterize longitudinal, objectively measured, physical activity and dietary patterns among PLHIV
- Examine the relationship between objectively-measured physical activity and self-reported physical activity on the Lipid Research Clinics Physical Activity Questionnaire.
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||850 participants|
|Official Title:||Impact of Physical Activity Routines and Dietary Intake on the Longitudinal Symptom Experience of People Living With HIV|
|Actual Study Start Date :||January 22, 2019|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||April 30, 2023|
People living with HIV (PLHIV).
We will recruit and enroll 850 people living with HIV (PLHIV) to participate in this longitudinal observational study.
Other: No intervention
As an observational study, no intervention will be associated with the study group.
- Symptom Distress [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790501
|Contact: Christine Horvat Davey, BS, PhD(c)||firstname.lastname@example.org|
|Contact: Cynthia Rentrope, MPHemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35205|
|Contact: Tammi Thomas, BS 205-934-7839 firstname.lastname@example.org|
|Principal Investigator: Amanda Willig, RD, PhD|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02215|
|Contact: Matteo Peretti 206-616-0201 MPeretti@fenwayhealth.org|
|Principal Investigator: Kenneth H Mayer, MD|
|United States, Ohio|
|Case Western Reserve University||Recruiting|
|Cleveland, Ohio, United States, 44106|
|United States, Washington|
|University of Washington||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Laurie Smith, BA 206-616-0101 email@example.com|
|Principal Investigator: Heidi Crane, MD, MPH|
|Principal Investigator:||Allison Webel, BSN, PhD||Case Western Reserve University|
|Principal Investigator:||Amanda Willig, BS, PhD||University of Alabama at Brimingham|