iSTEP - an mHealth Physical Activity and Diet Intervention for Persons With HIV (NCT03123731) | Clinical Trial Compass
CompletedNot Applicable
iSTEP - an mHealth Physical Activity and Diet Intervention for Persons With HIV
United States100 participantsStarted 2018-12-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Physical Activity - Total Steps Recorded During 24 Weeks