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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 : Not yet recruiting
First Posted : December 31, 2018
Last Update Posted : December 31, 2018
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Allison Webel, Case Western Reserve University

Brief Summary:
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.

Condition or disease Intervention/treatment
HIV/AIDS Other: No intervention

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 850 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Physical Activity Routines and Dietary Intake on the Longitudinal Symptom Experience of People Living With HIV
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will recruit and enroll 850 people living with HIV (PLHIV) who participate in the Centers for AIDS Research Network of Integrated Clinical Systems cohort to participate in this longitudinal observational study.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1) 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.


Information from the National Library of Medicine

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


Contacts
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Contact: Christine Horvat Davey, BS, PhD(c) 84663686237 cmh166@case.edu
Contact: Cynthia Rentrope, MPH 21636804789 crr57@case.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35205
Contact: Tammi Thomas, BS    205-902-9412    tamms@uabmc.edu   
Principal Investigator: Amanda Willig, RD, PhD         
United States, Massachusetts
Fenway Institute Not yet recruiting
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
Cleveland, Ohio, United States, 44106
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98104
Contact: Laurie Smith, BA    206-616-0101    laursmit@uw.edu   
Principal Investigator: Heidi Crane, MD, MPH         
Sponsors and Collaborators
Case Western Reserve University
University of Alabama at Birmingham
Investigators
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Principal Investigator: Allison Webel, BSN, PhD Case Western Reserve University
Principal Investigator: Amanda Willig, BS, PhD University of Alabama at Brimingham

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Responsible Party: Allison Webel, Assistant Profsssor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT03790501     History of Changes
Other Study ID Numbers: R01NR018391 ( U.S. NIH Grant/Contract )
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared consistent with the CNICS Data Sharing Policy found here: https://www.uab.edu/cnics/images/CNICSdatasharing_policy_v081515.pdf
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
URL: https://www.uab.edu/cnics/images/CNICSdatasharing_policy_v081515.pdf

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No