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

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control Arm
iSTEP
iSTEP
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring physical activity, diet, mHealth, Fitbit, neurocognition, text messaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • HIV Neurobehavioral Research Program

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control Arm

iSTEP PA intervention

iSTEP PA and diet intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Physical activity - steps per day
Average number of daily steps recorded by the Fitbit
Diet History Questionnaire (DHQ)
DHQ assessment of the percent of fat, carbohydrate, and protein intake in participant diet over the past month

Secondary Outcome Measures

Sedentary behavior - minutes per day
Average daily minutes of sedentary behavior (counts < 100/minute) quantified by GT3X Actigraph
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.
Physical activity - moderate physical activity measured by actigraph
Average daily minutes of moderate physical activity quantified by GT3X Actigraph
Physical activity - daily energy expenditure
Seven-day Physical Activity Recall - kilocalories per day
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.
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.
Interleukin-6 (IL6)
Levels of IL6 in plasma
C-reactive protein (CRP)
Levels of CRP in plasma
D-dimer
Levels of D-dimer in plasma
Tumor necrosis factor alpha (TNFa)
Levels of TNFa in plasma
Total cholesterol (TC)
Levels of TC in plasma
Low density lipoprotein cholesterol (LDL-C)
Levels of LDL-C in plasma
High density lipoprotein cholesterol (HDL-C)
Levels of HDL-C in plasma
Triglycerides
Levels of triglycerides in plasma
Wechsler Adult Intelligence Scale (WAIS) Digit Symbol
Neurocognitive assessment
WAIS Symbol Search
Neurocognitive assessment
Trail Making Test Part A
Neurocognitive assessment
Trail Making Test Part B
Neurocognitive assessment
Hopkins Verbal Learning Test - Revised
Neurocognitive assessment
Brief Visuospatial Memory Test - Revised
Neurocognitive assessment
Wisconsin Card Sorting Test
Neurocognitive assessment
Controlled Oral Word Association Test
Neurocognitive assessment
Category Fluency
Neurocognitive assessment
WAIS Letter-Number Sequencing
Neurocognitive assessment
Paced Auditory Serial Addition Task
Neurocognitive assessment
Grooved Pegboard Test.
Neurocognitive assessment

Full Information

First Posted
April 11, 2017
Last Updated
September 25, 2023
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT03123731
Brief Title
iSTEP - an mHealth Physical Activity and Diet Intervention for Persons With HIV
Official Title
iSTEP - an mHealth Physical Activity and Diet Intervention for Persons With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
physical activity, diet, mHealth, Fitbit, neurocognition, text messaging

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention.
Arm Title
iSTEP PA intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
iSTEP PA and diet intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Arm
Intervention Description
Wearing Physical Activity Monitor
Intervention Type
Behavioral
Intervention Name(s)
iSTEP
Intervention Description
Physical Activity Intervention
Intervention Type
Behavioral
Intervention Name(s)
iSTEP
Intervention Description
Physical Activity and Diet Intervention
Primary Outcome Measure Information:
Title
Physical activity - steps per day
Description
Average number of daily steps recorded by the Fitbit
Time Frame
6 months
Title
Diet History Questionnaire (DHQ)
Description
DHQ assessment of the percent of fat, carbohydrate, and protein intake in participant diet over the past month
Time Frame
Change from baseline to the 6-month visit after intervention
Secondary Outcome Measure Information:
Title
Sedentary behavior - minutes per day
Description
Average daily minutes of sedentary behavior (counts < 100/minute) quantified by GT3X Actigraph
Time Frame
Change from first week (Week 1) to last week (Week 24) of the intervention
Title
Fitness - 6-minute walk test (6MWT)
Description
Time to complete 6-minute walk test around a 30 yard course; the score is the total yard distance completed.
Time Frame
Change from baseline to the 6-month visit after intervention
Title
Physical activity - moderate physical activity measured by actigraph
Description
Average daily minutes of moderate physical activity quantified by GT3X Actigraph
Time Frame
Change from first week (Week 1) to last week (Week 24) of the intervention
Title
Physical activity - daily energy expenditure
Description
Seven-day Physical Activity Recall - kilocalories per day
Time Frame
Change from first week (Week 1) to last week (Week 24) of the intervention
Title
Polyunsaturated fatty acids (PUFA) in plasma
Description
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.
Time Frame
Change from baseline to the 6-month visit after intervention
Title
Carotenoids in plasma
Description
One reported value of the total carotenoid amount, consisting of the sum of alpha-carotene, beta-carotene, lutein, lycopene and betacryptoxanthin levels in plasma.
Time Frame
Change from baseline to the 6-month visit after intervention
Title
Interleukin-6 (IL6)
Description
Levels of IL6 in plasma
Time Frame
Change from baseline to the 6-month visit after intervention
Title
C-reactive protein (CRP)
Description
Levels of CRP in plasma
Time Frame
Change from baseline to the 6-month visit after intervention
Title
D-dimer
Description
Levels of D-dimer in plasma
Time Frame
Change from baseline to the 6-month visit after intervention
Title
Tumor necrosis factor alpha (TNFa)
Description
Levels of TNFa in plasma
Time Frame
Change from baseline to the 6-month visit after intervention
Title
Total cholesterol (TC)
Description
Levels of TC in plasma
Time Frame
Change from baseline to the 6-month visit after intervention
Title
Low density lipoprotein cholesterol (LDL-C)
Description
Levels of LDL-C in plasma
Time Frame
Change from baseline to the 6-month visit after intervention
Title
High density lipoprotein cholesterol (HDL-C)
Description
Levels of HDL-C in plasma
Time Frame
Change from baseline to the 6-month visit after intervention
Title
Triglycerides
Description
Levels of triglycerides in plasma
Time Frame
Change from baseline to the 6-month visit after intervention
Title
Wechsler Adult Intelligence Scale (WAIS) Digit Symbol
Description
Neurocognitive assessment
Time Frame
Change from baseline to the 6-month visit after intervention
Title
WAIS Symbol Search
Description
Neurocognitive assessment
Time Frame
Change from baseline to the 6-month visit after intervention
Title
Trail Making Test Part A
Description
Neurocognitive assessment
Time Frame
Change from baseline to the 6-month visit after intervention
Title
Trail Making Test Part B
Description
Neurocognitive assessment
Time Frame
Change from baseline to the 6-month visit after intervention
Title
Hopkins Verbal Learning Test - Revised
Description
Neurocognitive assessment
Time Frame
Change from baseline to the 6-month visit after intervention
Title
Brief Visuospatial Memory Test - Revised
Description
Neurocognitive assessment
Time Frame
Change from baseline to the 6-month visit after intervention
Title
Wisconsin Card Sorting Test
Description
Neurocognitive assessment
Time Frame
Change from baseline to the 6-month visit after intervention
Title
Controlled Oral Word Association Test
Description
Neurocognitive assessment
Time Frame
Change from baseline to the 6-month visit after intervention
Title
Category Fluency
Description
Neurocognitive assessment
Time Frame
Change from baseline to the 6-month visit after intervention
Title
WAIS Letter-Number Sequencing
Description
Neurocognitive assessment
Time Frame
Change from baseline to the 6-month visit after intervention
Title
Paced Auditory Serial Addition Task
Description
Neurocognitive assessment
Time Frame
Change from baseline to the 6-month visit after intervention
Title
Grooved Pegboard Test.
Description
Neurocognitive assessment
Time Frame
Change from baseline to the 6-month visit after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brook L Henry, Ph.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
HIV Neurobehavioral Research Program
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30669986
Citation
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.
Results Reference
derived

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

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