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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 : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Brook Henry, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE April 11, 2017
First Posted Date  ICMJE April 21, 2017
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
  • Physical activity - steps per day [ Time Frame: 6 months ]
    Average number of daily steps recorded by the Fitbit
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
  • 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
  • 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.
  • 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
  • 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
  • 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.
  • 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.
  • Interleukin-6 (IL6) [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Levels of IL6 in plasma
  • C-reactive protein (CRP) [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Levels of CRP in plasma
  • D-dimer [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Levels of D-dimer in plasma
  • Tumor necrosis factor alpha (TNFa) [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Levels of TNFa in plasma
  • Total cholesterol (TC) [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Levels of TC in plasma
  • Low density lipoprotein cholesterol (LDL-C) [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Levels of LDL-C in plasma
  • High density lipoprotein cholesterol (HDL-C) [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Levels of HDL-C in plasma
  • Triglycerides [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Levels of triglycerides in plasma
  • Wechsler Adult Intelligence Scale (WAIS) Digit Symbol [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment
  • WAIS Symbol Search [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment
  • Trail Making Test Part A [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment
  • Trail Making Test Part B [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment
  • Hopkins Verbal Learning Test - Revised [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment
  • Brief Visuospatial Memory Test - Revised [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment
  • Wisconsin Card Sorting Test [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment
  • Controlled Oral Word Association Test [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment
  • Category Fluency [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment
  • WAIS Letter-Number Sequencing [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment
  • Paced Auditory Serial Addition Task [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment
  • Grooved Pegboard Test. [ Time Frame: Change from baseline to the 6-month visit after intervention ]
    Neurocognitive assessment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE iSTEP - an mHealth Physical Activity and Diet Intervention for Persons With HIV
Official Title  ICMJE iSTEP - an mHealth Physical Activity and Diet Intervention for Persons With HIV
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV/AIDS
Intervention  ICMJE
  • Behavioral: Control Arm
    Wearing Physical Activity Monitor
  • Behavioral: iSTEP
    Physical Activity Intervention
  • Behavioral: iSTEP
    Physical Activity and Diet Intervention
Study Arms  ICMJE
  • Active Comparator: Control Arm
    Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention.
    Intervention: Behavioral: Control Arm
  • 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.
    Intervention: Behavioral: iSTEP
  • 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.
    Intervention: Behavioral: iSTEP
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2017)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brook L Henry, Ph.D. 619-543-4737 blhenry@ucsd.edu
Contact: Recruitment Office hnrprecruitment@ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03123731
Other Study ID Numbers  ICMJE 161347
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brook Henry, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brook L Henry, Ph.D. University of California, San Diego
PRS Account University of California, San Diego
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP