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

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ClinicalTrials.gov Identifier: NCT03123731
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Brook Henry, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Control Arm Behavioral: iSTEP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: iSTEP - an mHealth Physical Activity and Diet Intervention for Persons With HIV
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Arm
Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention.
Behavioral: Control Arm
Wearing Physical Activity Monitor

Experimental: iSTEP PA intervention
Participants will wear a Fitbit and receive interactive daily text messages that are designed to motivate moderate physical activity (PA) and reduce sedentary behavior, including setting weekly goals to increase average daily step counts.
Behavioral: iSTEP
Physical Activity Intervention

Experimental: iSTEP PA and diet intervention
Participants will wear a Fitbit and receive interactive daily text messages that are designed to motivate moderate physical activity (PA), reduce sedentary behavior, and promote adherence to a Mediterranean-style diet. Participants will also be administered diet counseling from a registered dietitian and receive weekly feedback on both physical activity and diet behaviors.
Behavioral: iSTEP
Physical Activity and Diet Intervention




Primary Outcome Measures :
  1. Physical activity - steps per day [ Time Frame: 6 months ]
    Average number of daily steps recorded by the Fitbit

  2. Diet History Questionnaire (DHQ) [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    DHQ assessment of the percent of fat, carbohydrate, and protein intake in participant diet over the past month


Secondary Outcome Measures :
  1. Sedentary behavior - minutes per day [ Time Frame: Change from first week (Week 1) to last week (Week 24) of the intervention ]
    Average daily minutes of sedentary behavior (counts < 100/minute) quantified by GT3X Actigraph

  2. Fitness - 6-minute walk test (6MWT) [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Time to complete 6-minute walk test around a 30 yard course; the score is the total yard distance completed.

  3. Physical activity - moderate physical activity measured by actigraph [ Time Frame: Change from first week (Week 1) to last week (Week 24) of the intervention ]
    Average daily minutes of moderate physical activity quantified by GT3X Actigraph

  4. Physical activity - daily energy expenditure [ Time Frame: Change from first week (Week 1) to last week (Week 24) of the intervention ]
    Seven-day Physical Activity Recall - kilocalories per day

  5. Polyunsaturated fatty acids (PUFA) in plasma [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    One reported value of the total PUFA amount, consisting of the sum of α-linoleic acid (ALA), eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and docosapentaenoic acid (DPA) levels in plasma.

  6. Carotenoids in plasma [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    One reported value of the total carotenoid amount, consisting of the sum of alpha-carotene, beta-carotene, lutein, lycopene and betacryptoxanthin levels in plasma.

  7. Interleukin-6 (IL6) [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Levels of IL6 in plasma

  8. C-reactive protein (CRP) [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Levels of CRP in plasma

  9. D-dimer [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Levels of D-dimer in plasma

  10. Tumor necrosis factor alpha (TNFa) [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Levels of TNFa in plasma

  11. Total cholesterol (TC) [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Levels of TC in plasma

  12. Low density lipoprotein cholesterol (LDL-C) [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Levels of LDL-C in plasma

  13. High density lipoprotein cholesterol (HDL-C) [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Levels of HDL-C in plasma

  14. Triglycerides [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Levels of triglycerides in plasma

  15. Wechsler Adult Intelligence Scale (WAIS) Digit Symbol [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment

  16. WAIS Symbol Search [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment

  17. Trail Making Test Part A [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment

  18. Trail Making Test Part B [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment

  19. Hopkins Verbal Learning Test - Revised [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment

  20. Brief Visuospatial Memory Test - Revised [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment

  21. Wisconsin Card Sorting Test [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment

  22. Controlled Oral Word Association Test [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment

  23. Category Fluency [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment

  24. WAIS Letter-Number Sequencing [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment

  25. Paced Auditory Serial Addition Task [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment

  26. Grooved Pegboard Test. [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123731


Contacts
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Contact: Brook L Henry, Ph.D. 619-543-4737 blhenry@ucsd.edu
Contact: Recruitment Office hnrprecruitment@ucsd.edu

Locations
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United States, California
HIV Neurobehavioral Research Program Recruiting
San Diego, California, United States, 92103
Contact: Brook L Henry, Ph.D.    619-543-4737    blhenry@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Brook L Henry, Ph.D. University of California, San Diego

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brook Henry, Assistant Research Scientist, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03123731     History of Changes
Other Study ID Numbers: 161347
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brook Henry, University of California, San Diego:
physical activity
diet
mHealth
Fitbit
neurocognition
text messaging