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 : Unknown
Verified June 2021 by Allison Webel, University of Washington.
Recruitment status was: Recruiting
First Posted : December 31, 2018
Last Update Posted : June 8, 2021
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Condition or disease | Intervention/treatment |
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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 |
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 |
Actual Study Start Date : | January 22, 2019 |
Estimated Primary Completion Date : | April 30, 2023 |
Estimated Study Completion Date : | April 30, 2023 |
Group/Cohort | Intervention/treatment |
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People living with HIV (PLHIV).
We will recruit and enroll 850 people living with HIV (PLHIV) to participate in this longitudinal observational study.
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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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
Inclusion Criteria:
- 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.
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.
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: Vitor Oliveira, PhD | 216-972-2713 | vitorhfo@uw.edu |
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35205 | |
Contact: Tammi Thomas, BS 205-934-7839 tamms@uabmc.edu | |
Principal Investigator: Amanda Willig, RD, PhD | |
United States, Massachusetts | |
Fenway Institute | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Matteo Peretti 206-616-0201 MPeretti@fenwayhealth.org | |
Principal Investigator: Julia Fleming, 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 laursmit@uw.edu | |
Principal Investigator: Heidi Crane, MD, MPH |
Principal Investigator: | Allison Webel, BSN, PhD | University of Washington |
Responsible Party: | Allison Webel, Assistant Professor, University of Washington |
ClinicalTrials.gov Identifier: | NCT03790501 |
Other Study ID Numbers: |
STUDY00013048 R01NR018391 ( U.S. NIH Grant/Contract ) |
First Posted: | December 31, 2018 Key Record Dates |
Last Update Posted: | June 8, 2021 |
Last Verified: | June 2021 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Acquired Immunodeficiency Syndrome HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections |
Retroviridae Infections RNA Virus Infections Virus Diseases Slow Virus Diseases Genital Diseases Urogenital Diseases Immunologic Deficiency Syndromes Immune System Diseases |