Impact of Physical Activity and Diet on Symptom Experience in People Living With HIV

NCT ID: NCT03790501

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 850 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-22
• Study Completion Date: 2023-04-30

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.

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.

Conditions

HIV/AIDS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

People living with HIV (PLHIV).

We will recruit and enroll 850 people living with HIV (PLHIV) to participate in this longitudinal observational study.

No intervention

Intervention Type: OTHER

As an observational study, no intervention will be associated with the study group.

Interventions

No intervention

As an observational study, no intervention will be associated with the study group.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Allison Webel

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allison Webel, BSN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Fenway Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Case Western Reserve University

Cleveland, Ohio, United States

Site Status: RECRUITING

University of Washington

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Vitor Oliveira, PhD

Role: CONTACT

vitorhfo@uw.edu

216-972-2713

Facility Contacts

Tammi Thomas, BS

Role: primary

tamms@uabmc.edu

205-934-7839

Matteo Peretti

Role: primary

MPeretti@fenwayhealth.org

206-616-0201

Laurie Smith, BA

Role: primary

laursmit@uw.edu

206-616-0101

References

Horvat Davey C, Willig AL, Ruderman SA, Dos Santos AP, Oliveira V, Gripshover BM, Long DM, Cleveland JD, Crane HM, Fleming J, Buford TW, Burkholder G, Saag MS, Webel AR. Exploring the Relationship Between Insomnia and Biological Factors, Substance Use, and Physical Activity in People With HIV in the United States: Insights From the PROSPER Study. J Assoc Nurses AIDS Care. 2025 Oct 1. doi: 10.1097/JNC.0000000000000589. Online ahead of print.

Reference Type: DERIVED

PMID: 41026762 (View on PubMed)

Oliveira VHF, Willig AL, Horvat Davey C, Buford TW, Menezes P, Cachay E, Crane HM, Burkholder GA, Gripshover BM, Fleming JG, Cleveland JD, Webel AR. Brief Report: Relationship Between Adiposity and Biomarkers of Aging and Frailty Among Adults Aging With HIV. J Acquir Immune Defic Syndr. 2024 Apr 1;95(4):377-382. doi: 10.1097/QAI.0000000000003362.

Reference Type: DERIVED

PMID: 38100820 (View on PubMed)

Webel AR, Davey CH, Oliveira V, Cleveland D, Crane HM, Gripshover BM, Long DM, Fleming JG, Buford TW, Willig AL. Physical activity is associated with adiposity in older adults with HIV in the modern HIV era. AIDS. 2023 Oct 1;37(12):1819-1826. doi: 10.1097/QAD.0000000000003635. Epub 2023 Jun 27.

Reference Type: DERIVED

PMID: 37382891 (View on PubMed)

Webel AR, Long D, Rodriguez B, Davey CH, Buford TW, Crane HM, Mayer K, Saag MS, Willig AL. The PROSPER-HIV Study: A Research Protocol to Examine Relationships Among Physical Activity, Diet Intake, and Symptoms in Adults Living With HIV. J Assoc Nurses AIDS Care. 2020 May-Jun;31(3):346-352. doi: 10.1097/JNC.0000000000000145. No abstract available.

Reference Type: DERIVED

PMID: 31789686 (View on PubMed)

Other Identifiers

R01NR018391

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00013048

Identifier Type: -

Identifier Source: org_study_id