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

NCT ID: NCT03123731

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2023-08-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Arm

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

Group Type: ACTIVE_COMPARATOR

Control Arm

Intervention Type: BEHAVIORAL

Wearing Physical Activity Monitor

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.

Group Type: EXPERIMENTAL

iSTEP

Intervention Type: BEHAVIORAL

Physical Activity Intervention

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.

Group Type: EXPERIMENTAL

iSTEP

Intervention Type: BEHAVIORAL

Physical Activity and Diet Intervention

Interventions

Control Arm

Wearing Physical Activity Monitor

Intervention Type: BEHAVIORAL

iSTEP

Physical Activity Intervention

Intervention Type: BEHAVIORAL

iSTEP

Physical Activity and Diet Intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Brook Henry

Associate Project Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brook L Henry, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

HIV Neurobehavioral Research Program

San Diego, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30669986 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5R01AG074808

Identifier Type: NIH

Identifier Source: secondary_id

View Link

161347

Identifier Type: -

Identifier Source: org_study_id