Clinical trial NCT03790501: Impact of Physical Activity and Diet on Symptom Experience in People Living With HIV
Official title: Impact of Physical Activity Routines and Dietary Intake on the Longitudinal Symptom Experience of People Living With HIV
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV/AIDS
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: National Institute of Nursing Research (NINR)
First posted: 2018-12-31
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Symptom Distress
timeFrame: Four years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Boston
country: United States
facility: Fenway Institute
state: Massachusetts
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Allison Webel, BSN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.