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Completed

NCT Number: NCT03123731

iSTEP - an mHealth Physical Activity and Diet Intervention for Persons With HIV

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Motor Activity RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HIV Neurobehavioral Research Program

San Diego, California, 92103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Control arm

Behavioral

Wearing Physical Activity Monitor

iSTEP

Behavioral

Physical Activity Intervention

Primary outcomes

  1. Physical Activity - Total Steps Recorded During 24 Weeks

    Time frame: 6 months

    Total number of steps recorded by the Fitbit over 24 weeks. Zero is the minimum and there is no maximum. Higher scores (steps) indicates a better outcome.

Secondary outcomes

  1. Physical Activity - Change in Average Daily Steps Per Day Between Week 1 and Week 24

    Time frame: 24 weeks

    This is the change in average daily steps comparing the beginning (Week 1) and end (Week 24) of the intervention. A higher number is a positive outcome, indicated an increase in steps during the study. A negative number is a worse outcome, indicating a decline in steps during the intervention. Zero is the minimum and there is no maximum.

  2. Average Steps Per Day During the 24-week Intervention

    Time frame: 24 weeks

    This measure reports the average daily steps per day during the entire intervention (over 24 weeks). A higher number of steps indicates greater physical activity and is a positive outcome. A lower number of daily steps indicates lower physical activity. Zero is the minimum and there is no maximum.

  3. C-reactive Protein

    Time frame: 24 weeks

    The change in C-reactive protein between baseline and the follow-up visit after the 24-week intervention. Higher numbers indicate that inflammation increased over time, a worse outcome. Lower numbers indicate less inflammation, a better outcome.

  4. Change in Total Cholesterol.

    Time frame: 24 weeks

    This measures the change in total plasma cholesterol between the baseline visit and the 24-week follow-up visit. A decrease in cholesterol is healthy, while an increase is unhealthy.

  5. Level of GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme at the Baseline Visit

    Time frame: 1 day baseline visit

    This measures the plasma level of GPLD1 at the baseline study visit before the 24-week intervention. Higher levels are hypothesized to be positive and associated with better health and lower inflammation.The minimum level is zero and there is no maximum limit.

  6. Change in GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme Between the Baseline and 24-week Visit

    Time frame: 24 weeks

    This measures the change in GPLD1 between the baseline and 24-week visit after the study intervention. An increase in GPLD1 is hypothesized to associate with health benefits, while a decrease is a negative outcome.

  7. Association Between Physical Activity (PA) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at Baseline

    Time frame: 1 week

    This measures the correlation (Pearson r) between GPLD1 (measured on one 1 day) and participant PA (assessed by average daily steps for 1 week) at the baseline before the 24-week intervention. A positive number indicates that higher GPLD1 was associated with greater PA. A negative number indicates that higher GPLD1 associates with lower PA. The minimum value is -1. The maximum value is +1.

  8. 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

    Time frame: 24 weeks

    This measures the correlation (Pearson r) between the change in GPLD1 across the baseline and 24-week visits and the change in PA (average daily steps) between the first week (Week 1) and last week (Week 24) of the study. A positive number indicates that an increase in GPLD1 associated with an increase in PA over time, a negative number indicates the opposite. The minimum value is -1. The maximum value is +1.

  9. Association Between Cognitive Performance (Executive Function) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at the 24-week Visit After the Intervention

    Time frame: 1 day at the end of the 24-week intervention

    This measures the correlation (Pearson r) between GPLD1 and executive function (measured by T score) at the 24-week visit after the intervention. A positive number indicates that higher GPLD1 associates with better executive function. A negative number indicates that higher GPLD1 associates with worse cognition (lower T score). The minimum value is -1. The maximum value is +1.

  10. 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.

    Time frame: 24 weeks

    This measures the correlation (Pearson r) between the change in CRP and the change in GPLD1 across the baseline and 24-week visits. A positive number indicates that an increase in GPLD1 associated with an increase in CRP (higher inflammation). A negative number indicates that an increase in GPLD1 associated with a decrease in CRP (lower inflammation). The minimum value is -1. The maximum value is +1.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2017
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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