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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AG074808 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Active Comparator | Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Arm | Behavioral | Wearing Physical Activity Monitor |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity - Change in Average Daily Steps Per Day Between Week 1 and Week 24 | This is the change in average daily steps comparing the beginning (Week 1) and end (Week 24) of the intervention. A higher number is a positive outcome, indicated an increase in steps during the study. A negative number is a worse outcome, indicating a decline in steps during the intervention. Zero is the minimum and there is no maximum. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brook L Henry, Ph.D. | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HIV Neurobehavioral Research Program | San Diego | California | 92103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30669986 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm | Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: Wearing Physical Activity Monitor |
| FG001 | 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. iSTEP: Physical Activity Intervention |
| FG002 | 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. iSTEP: Physical Activity and Diet Intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm | Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: Wearing Physical Activity Monitor |
| BG001 | iSTEP PA Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | steps | 6 months |
|
Adverse events were monitored during the 24-week (6-month) study intervention for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Arm | Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: Wearing Physical Activity Monitor |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| minor muscle soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brook Henry | University of California, San Diego | 619-543-4737 | blhenry@ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2016 | Jul 15, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| iSTEP |
| Behavioral |
Physical Activity Intervention |
|
| iSTEP | Behavioral | Physical Activity and Diet Intervention |
|
| 24 weeks |
| Average Steps Per Day During the 24-week Intervention | This measure reports the average daily steps per day during the entire intervention (over 24 weeks). A higher number of steps indicates greater physical activity and is a positive outcome. A lower number of daily steps indicates lower physical activity. Zero is the minimum and there is no maximum. | 24 weeks |
| C-reactive Protein | The change in C-reactive protein between baseline and the follow-up visit after the 24-week intervention. Higher numbers indicate that inflammation increased over time, a worse outcome. Lower numbers indicate less inflammation, a better outcome. | 24 weeks |
| Change in Total Cholesterol. | This measures the change in total plasma cholesterol between the baseline visit and the 24-week follow-up visit. A decrease in cholesterol is healthy, while an increase is unhealthy. | 24 weeks |
| Level of GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme at the Baseline Visit | This measures the plasma level of GPLD1 at the baseline study visit before the 24-week intervention. Higher levels are hypothesized to be positive and associated with better health and lower inflammation.The minimum level is zero and there is no maximum limit. | 1 day baseline visit |
| Change in GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme Between the Baseline and 24-week Visit | This measures the change in GPLD1 between the baseline and 24-week visit after the study intervention. An increase in GPLD1 is hypothesized to associate with health benefits, while a decrease is a negative outcome. | 24 weeks |
| Association Between Physical Activity (PA) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at Baseline | This measures the correlation (Pearson r) between GPLD1 (measured on one 1 day) and participant PA (assessed by average daily steps for 1 week) at the baseline before the 24-week intervention. A positive number indicates that higher GPLD1 was associated with greater PA. A negative number indicates that higher GPLD1 associates with lower PA. The minimum value is -1. The maximum value is +1. | 1 week |
| Association Between the Change in Physical Activity (PA) and Change in GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) Between the Baseline Visit and 24-week Visit After the Intervention | This measures the correlation (Pearson r) between the change in GPLD1 across the baseline and 24-week visits and the change in PA (average daily steps) between the first week (Week 1) and last week (Week 24) of the study. A positive number indicates that an increase in GPLD1 associated with an increase in PA over time, a negative number indicates the opposite. The minimum value is -1. The maximum value is +1. | 24 weeks |
| Association Between Cognitive Performance (Executive Function) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at the 24-week Visit After the Intervention | This measures the correlation (Pearson r) between GPLD1 and executive function (measured by T score) at the 24-week visit after the intervention. A positive number indicates that higher GPLD1 associates with better executive function. A negative number indicates that higher GPLD1 associates with worse cognition (lower T score). The minimum value is -1. The maximum value is +1. | 1 day at the end of the 24-week intervention |
| Association Between the Change in Inflammation (C-reactive Protein, or CRP) and Change in GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) Between the Baseline and 24-week Visits. | This measures the correlation (Pearson r) between the change in CRP and the change in GPLD1 across the baseline and 24-week visits. A positive number indicates that an increase in GPLD1 associated with an increase in CRP (higher inflammation). A negative number indicates that an increase in GPLD1 associated with a decrease in CRP (lower inflammation). The minimum value is -1. The maximum value is +1. | 24 weeks |
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.
iSTEP: Physical Activity Intervention
| BG002 | 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. iSTEP: Physical Activity and Diet Intervention |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | 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. iSTEP: Physical Activity and Diet Intervention |
|
|
| Secondary | Physical Activity - Change in Average Daily Steps Per Day Between Week 1 and Week 24 | This is the change in average daily steps comparing the beginning (Week 1) and end (Week 24) of the intervention. A higher number is a positive outcome, indicated an increase in steps during the study. A negative number is a worse outcome, indicating a decline in steps during the intervention. Zero is the minimum and there is no maximum. | Posted | Mean | Standard Error | steps/day | 24 weeks |
|
|
|
| Secondary | Average Steps Per Day During the 24-week Intervention | This measure reports the average daily steps per day during the entire intervention (over 24 weeks). A higher number of steps indicates greater physical activity and is a positive outcome. A lower number of daily steps indicates lower physical activity. Zero is the minimum and there is no maximum. | Posted | Mean | Standard Error | steps/day | 24 weeks |
|
|
|
| Secondary | C-reactive Protein | The change in C-reactive protein between baseline and the follow-up visit after the 24-week intervention. Higher numbers indicate that inflammation increased over time, a worse outcome. Lower numbers indicate less inflammation, a better outcome. | Posted | Mean | Standard Error | pg/ml | 24 weeks |
|
|
|
| Secondary | Change in Total Cholesterol. | This measures the change in total plasma cholesterol between the baseline visit and the 24-week follow-up visit. A decrease in cholesterol is healthy, while an increase is unhealthy. | Posted | Mean | Standard Error | mg/dL | 24 weeks |
|
|
|
| Secondary | Level of GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme at the Baseline Visit | This measures the plasma level of GPLD1 at the baseline study visit before the 24-week intervention. Higher levels are hypothesized to be positive and associated with better health and lower inflammation.The minimum level is zero and there is no maximum limit. | Posted | Mean | Standard Error | pg/ml | 1 day baseline visit |
|
|
|
| Secondary | Change in GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme Between the Baseline and 24-week Visit | This measures the change in GPLD1 between the baseline and 24-week visit after the study intervention. An increase in GPLD1 is hypothesized to associate with health benefits, while a decrease is a negative outcome. | Posted | Mean | Standard Error | pg/ml | 24 weeks |
|
|
|
| Secondary | Association Between Physical Activity (PA) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at Baseline | This measures the correlation (Pearson r) between GPLD1 (measured on one 1 day) and participant PA (assessed by average daily steps for 1 week) at the baseline before the 24-week intervention. A positive number indicates that higher GPLD1 was associated with greater PA. A negative number indicates that higher GPLD1 associates with lower PA. The minimum value is -1. The maximum value is +1. | Posted | Number | Pearson's r | 1 week |
|
|
|
| Secondary | Association Between the Change in Physical Activity (PA) and Change in GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) Between the Baseline Visit and 24-week Visit After the Intervention | This measures the correlation (Pearson r) between the change in GPLD1 across the baseline and 24-week visits and the change in PA (average daily steps) between the first week (Week 1) and last week (Week 24) of the study. A positive number indicates that an increase in GPLD1 associated with an increase in PA over time, a negative number indicates the opposite. The minimum value is -1. The maximum value is +1. | Posted | Number | Pearson's r | 24 weeks |
|
|
|
| Secondary | Association Between Cognitive Performance (Executive Function) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at the 24-week Visit After the Intervention | This measures the correlation (Pearson r) between GPLD1 and executive function (measured by T score) at the 24-week visit after the intervention. A positive number indicates that higher GPLD1 associates with better executive function. A negative number indicates that higher GPLD1 associates with worse cognition (lower T score). The minimum value is -1. The maximum value is +1. | Posted | Number | Pearson's r | 1 day at the end of the 24-week intervention |
|
|
|
| Secondary | Association Between the Change in Inflammation (C-reactive Protein, or CRP) and Change in GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) Between the Baseline and 24-week Visits. | This measures the correlation (Pearson r) between the change in CRP and the change in GPLD1 across the baseline and 24-week visits. A positive number indicates that an increase in GPLD1 associated with an increase in CRP (higher inflammation). A negative number indicates that an increase in GPLD1 associated with a decrease in CRP (lower inflammation). The minimum value is -1. The maximum value is +1. | Posted | Number | Pearson's r | 24 weeks |
|
|
|
| 1 |
| 32 |
| 1 |
| 32 |
| 9 |
| 32 |
| EG001 | 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. iSTEP: Physical Activity Intervention | 0 | 35 | 0 | 35 | 10 | 35 |
| EG002 | 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. iSTEP: Physical Activity and Diet Intervention | 0 | 33 | 0 | 33 | 12 | 33 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001519 | Behavior |