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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: Control Arm; Behavioral: iSTEP; Behavioral: iSTEP

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Recruitment Office; Email: hnrprecruitment@ucsd.edu
• Study Contact Backup: Name: Brook L Henry, Ph.D.; Phone Number: 619-543-4737; Email: blhenry@ucsd.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • HIV Neurobehavioral Research Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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; Behavioral: iSTEP; Physical Activity and Diet 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 Intervention; Behavioral: iSTEP; Physical Activity and Diet Intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Brook L Henry, Ph.D., University of California, San Diego

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; mHealth; diet; text messaging; Fitbit; neurocognition
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 161347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No