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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03123731
• Other study ID #: 161347
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: May 31, 2023

Study information

• Verified date: September 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• Control Arm
Wearing Physical Activity Monitor
• iSTEP
Physical Activity Intervention
• iSTEP
Physical Activity and Diet Intervention

Locations

Country	Name	City	State
United States	HIV Neurobehavioral Research Program	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity - steps per day	Average number of daily steps recorded by the Fitbit	6 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Polyunsaturated fatty acids (PUFA) in plasma	One reported value of the total PUFA amount, consisting of the sum of a-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
Secondary	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
Secondary	Interleukin-6 (IL6)	Levels of IL6 in plasma	Change from baseline to the 6-month visit after intervention
Secondary	C-reactive protein (CRP)	Levels of CRP in plasma	Change from baseline to the 6-month visit after intervention
Secondary	D-dimer	Levels of D-dimer in plasma	Change from baseline to the 6-month visit after intervention
Secondary	Tumor necrosis factor alpha (TNFa)	Levels of TNFa in plasma	Change from baseline to the 6-month visit after intervention
Secondary	Total cholesterol (TC)	Levels of TC in plasma	Change from baseline to the 6-month visit after intervention
Secondary	Low density lipoprotein cholesterol (LDL-C)	Levels of LDL-C in plasma	Change from baseline to the 6-month visit after intervention
Secondary	High density lipoprotein cholesterol (HDL-C)	Levels of HDL-C in plasma	Change from baseline to the 6-month visit after intervention
Secondary	Triglycerides	Levels of triglycerides in plasma	Change from baseline to the 6-month visit after intervention
Secondary	Wechsler Adult Intelligence Scale (WAIS) Digit Symbol	Neurocognitive assessment	Change from baseline to the 6-month visit after intervention
Secondary	WAIS Symbol Search	Neurocognitive assessment	Change from baseline to the 6-month visit after intervention
Secondary	Trail Making Test Part A	Neurocognitive assessment	Change from baseline to the 6-month visit after intervention
Secondary	Trail Making Test Part B	Neurocognitive assessment	Change from baseline to the 6-month visit after intervention
Secondary	Hopkins Verbal Learning Test - Revised	Neurocognitive assessment	Change from baseline to the 6-month visit after intervention
Secondary	Brief Visuospatial Memory Test - Revised	Neurocognitive assessment	Change from baseline to the 6-month visit after intervention
Secondary	Wisconsin Card Sorting Test	Neurocognitive assessment	Change from baseline to the 6-month visit after intervention
Secondary	Controlled Oral Word Association Test	Neurocognitive assessment	Change from baseline to the 6-month visit after intervention
Secondary	Category Fluency	Neurocognitive assessment	Change from baseline to the 6-month visit after intervention
Secondary	WAIS Letter-Number Sequencing	Neurocognitive assessment	Change from baseline to the 6-month visit after intervention
Secondary	Paced Auditory Serial Addition Task	Neurocognitive assessment	Change from baseline to the 6-month visit after intervention
Secondary	Grooved Pegboard Test.	Neurocognitive assessment	Change from baseline to the 6-month visit after intervention