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

NCT03123731 | Completed Results

• 2 other identifiers: 1613475R01AG074808
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

physical activity; diet; mHealth; Fitbit; neurocognition; text messaging

Outcome Measures

Primary Outcomes (1)

• Physical Activity - Total Steps Recorded During 24 Weeks

  Total number of steps recorded by the Fitbit over 24 weeks. Zero is the minimum and there is no maximum. Higher scores (steps) indicates a better outcome.

  6 months

Secondary Outcomes (10)

• Physical Activity - Change in Average Daily Steps Per Day Between Week 1 and Week 24

  24 weeks

• Average Steps Per Day During the 24-week Intervention

  24 weeks

• C-reactive Protein

  24 weeks

• Change in Total Cholesterol.

  24 weeks

• Level of GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme at the Baseline Visit

  1 day baseline visit

Study Arms (3)

Control Arm

ACTIVE COMPARATOR

Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention.

Behavioral: Control Arm

iSTEP PA intervention

EXPERIMENTAL

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

iSTEP PA and diet intervention

EXPERIMENTAL

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

Interventions

Control Arm BEHAVIORAL

Wearing Physical Activity Monitor

Control Arm

iSTEP BEHAVIORAL

Physical Activity Intervention

iSTEP PA intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

HIV Neurobehavioral Research Program

San Diego, California, 92103, United States

Location

Related Publications (1)

• 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.

  PMID: 30669986 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior

Results Point of Contact

• Title: Dr. Brook Henry
• Organization: University of California, San Diego

blhenry@ucsd.edu

619-543-4737

Study Officials

• Brook L Henry, Ph.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Project Scientist

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 21, 2017
• Study Start: December 1, 2018
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)