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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: Control Arm
* Behavioral: iSTEP
* Behavioral: iSTEP


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Arm<br>Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. | Behavioral: Control Arm<br>* Wearing Physical Activity Monitor<br>|
| Experimental: iSTEP PA intervention<br>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<br>* Physical Activity Intervention<br>|
| Experimental: iSTEP PA and diet intervention<br>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<br>* Physical Activity and Diet Intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity - steps per day | Average number of daily steps recorded by the Fitbit | 6 months | 
| Diet History Questionnaire (DHQ) | DHQ assessment of the percent of fat, carbohydrate, and protein intake in participant diet over the past month | Change from baseline to the 6-month visit after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedentary behavior - minutes per day | Average daily minutes of sedentary behavior (counts < 100/minute) quantified by GT3X Actigraph | Change from first week (Week 1) to last week (Week 24) of the intervention | 
| Fitness - 6-minute walk test (6MWT) | Time to complete 6-minute walk test around a 30 yard course; the score is the total yard distance completed. | Change from baseline to the 6-month visit after intervention | 
| Physical activity - moderate physical activity measured by actigraph | Average daily minutes of moderate physical activity quantified by GT3X Actigraph | Change from first week (Week 1) to last week (Week 24) of the intervention | 
| Physical activity - daily energy expenditure | Seven-day Physical Activity Recall - kilocalories per day | Change from first week (Week 1) to last week (Week 24) of the intervention | 
| Polyunsaturated fatty acids (PUFA) in plasma | 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. | Change from baseline to the 6-month visit after intervention | 
| Carotenoids in plasma | One reported value of the total carotenoid amount, consisting of the sum of alpha-carotene, beta-carotene, lutein, lycopene and betacryptoxanthin levels in plasma. | Change from baseline to the 6-month visit after intervention | 
| Interleukin-6 (IL6) | Levels of IL6 in plasma | Change from baseline to the 6-month visit after intervention | 
| C-reactive protein (CRP) | Levels of CRP in plasma | Change from baseline to the 6-month visit after intervention | 
| D-dimer | Levels of D-dimer in plasma | Change from baseline to the 6-month visit after intervention | 
| Tumor necrosis factor alpha (TNFa) | Levels of TNFa in plasma | Change from baseline to the 6-month visit after intervention | 
| Total cholesterol (TC) | Levels of TC in plasma | Change from baseline to the 6-month visit after intervention | 
| Low density lipoprotein cholesterol (LDL-C) | Levels of LDL-C in plasma | Change from baseline to the 6-month visit after intervention | 
| High density lipoprotein cholesterol (HDL-C) | Levels of HDL-C in plasma | Change from baseline to the 6-month visit after intervention | 
| Triglycerides | Levels of triglycerides in plasma | Change from baseline to the 6-month visit after intervention | 
| Wechsler Adult Intelligence Scale (WAIS) Digit Symbol | Neurocognitive assessment | Change from baseline to the 6-month visit after intervention | 
| WAIS Symbol Search | Neurocognitive assessment | Change from baseline to the 6-month visit after intervention | 
| Trail Making Test Part A | Neurocognitive assessment | Change from baseline to the 6-month visit after intervention | 
| Trail Making Test Part B | Neurocognitive assessment | Change from baseline to the 6-month visit after intervention | 
| Hopkins Verbal Learning Test - Revised | Neurocognitive assessment | Change from baseline to the 6-month visit after intervention | 
| Brief Visuospatial Memory Test - Revised | Neurocognitive assessment | Change from baseline to the 6-month visit after intervention | 
| Wisconsin Card Sorting Test | Neurocognitive assessment | Change from baseline to the 6-month visit after intervention | 
| Controlled Oral Word Association Test | Neurocognitive assessment | Change from baseline to the 6-month visit after intervention | 
| Category Fluency | Neurocognitive assessment | Change from baseline to the 6-month visit after intervention | 
| WAIS Letter-Number Sequencing | Neurocognitive assessment | Change from baseline to the 6-month visit after intervention | 
| Paced Auditory Serial Addition Task | Neurocognitive assessment | Change from baseline to the 6-month visit after intervention | 
| Grooved Pegboard Test. | Neurocognitive assessment | Change from baseline to the 6-month visit after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, diet, mHealth, Fitbit, neurocognition, text messaging