N/A
N=100
iSTEP - an mHealth Physical Activity and Diet Intervention for Persons With HIV
HIV/AIDS
Bottom Line
View on ClinicalTrials.gov: NCT03123731 ↗Enrolled (actual)
100
Serious AEs
1.0%
Results posted
Sep 2024
Primary outcome: Primary: Physical Activity - Total Steps Recorded During 24 Weeks — 1345700; 1686395; 1684843 steps
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Control Arm (Behavioral); iSTEP (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physical Activity - Total Steps Recorded During 24 Weeks |
1345700; 1686395; 1684843 | — |
| SECONDARY Physical Activity - Change in Average Daily Steps Per Day Between Week 1 and Week 24 |
-1504; 1667; -685 | — |
| SECONDARY Average Steps Per Day During the 24-week Intervention |
8081; 10850; 10015 | — |
| SECONDARY C-reactive Protein |
-289405; -63545; -239997 | — |
| SECONDARY Change in Total Cholesterol. |
2.14; 17.83; 10.04 | — |
| SECONDARY Level of GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme at the Baseline Visit |
190278; 196997; 168417 | — |
| SECONDARY Change in GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme Between the Baseline and 24-week Visit |
14497; -36496; 29674 | — |
| SECONDARY Association Between Physical Activity (PA) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at Baseline |
-0.175; -4.06; -0.05 | — |
| SECONDARY 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 |
-0.354; 0.147; 0.363 | — |
| SECONDARY Association Between Cognitive Performance (Executive Function) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at the 24-week Visit After the Intervention |
0.332; 0.226; 0.213 | — |
| SECONDARY 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. |
-0.401; -0.422; 0.174 | — |
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).
Data sourced from ClinicalTrials.gov (NCT03123731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.