Clinical trial NCT03123731: iSTEP - an mHealth Physical Activity and Diet Intervention for Persons With HIV
Official title: iSTEP - an mHealth Physical Activity and Diet Intervention for Persons With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: physical activity
diet
mHealth
Fitbit
neurocognition
text messaging
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-04-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: HIV is associated with a pattern of neurocognitive deficits, metabolic dysfunction, and an elevated risk for cardiovascular disease (CVD), phenomena that remain untreated despite the use of medications to control the disease. This proposal will examine the effect of a personalized, automated, interactive mobile phone text message intervention (iSTEP) designed to increase moderate physical activity (PA), decrease sedentary behavior (SB), and promote a healthy Mediterranean-style diet (MedDiet) in persons living with HIV (PLWH). The investigators propose that participants who receive the iSTEP intervention will increase the amount of physical activity, improve their diet, show a reduction in risk factors for CVD, and exhibit improved neurocognitive performance.


Eligibility criteria: Inclusion Criteria:

* ability to provide informed consent
* HIV infection documented at the University of California, San Diego (UCSD) HIV Neurobehavioral Research Program (HNRP) or assessed by an HIV test at screening
* proficient in English
* physically capable of participating in moderate PA as screened by the Physical Activity Readiness Questionnaire
* consent from primary care physician to participate in the study
* able to consume walnuts - no nut allergies

Exclusion Criteria:

* any physical conditions that would prevent moderate physical activity or where moderate physical activity would represent a health risk for the individual, including a history of myocardial infarction or stroke
* unwillingness or inability to participate in daily text messaging
* tree nut allergy that would prevent walnut consumption or other food restrictions that would prevent participation in the Mediterranean-style diet intervention (e.g., unable to eat fish or use olive oil for cooking).

Primary outcomes:
measure: Physical Activity - Total Steps Recorded During 24 Weeks
timeFrame: 6 months
Secondary outcomes:
measure: Physical Activity - Change in Average Daily Steps Per Day Between Week 1 and Week 24
timeFrame: 24 weeks
measure: Average Steps Per Day During the 24-week Intervention
timeFrame: 24 weeks
measure: C-reactive Protein
timeFrame: 24 weeks
measure: Change in Total Cholesterol.
timeFrame: 24 weeks
measure: Level of GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme at the Baseline Visit
timeFrame: 1 day baseline visit
measure: Change in GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme Between the Baseline and 24-week Visit
timeFrame: 24 weeks
measure: Association Between Physical Activity (PA) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at Baseline
timeFrame: 1 week
measure: Association Between the Change in Physical Activity (PA) and Change in GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) Between the Baseline Visit and 24-week Visit After the Intervention
timeFrame: 24 weeks
measure: Association Between Cognitive Performance (Executive Function) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at the 24-week Visit After the Intervention
timeFrame: 1 day at the end of the 24-week intervention
measure: Association Between the Change in Inflammation (C-reactive Protein, or CRP) and Change in GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) Between the Baseline and 24-week Visits.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: HIV Neurobehavioral Research Program
state: California
Study officials:
affiliation: University of California, San Diego
name: Brook L Henry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henry BL, Quintana E, Moore DJ, Garcia J, Montoya JL. Focus groups inform a mobile health intervention to promote adherence to a Mediterranean diet and engagement in physical activity among people living with HIV. BMC Public Health. 2019 Jan 22;19(1):101. doi: 10.1186/s12889-018-6386-5.