HIV/AIDS
Conditions
Keywords
physical activity, diet, mHealth, Fitbit, neurocognition, text messaging
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.
Interventions
BEHAVIORALControl Arm
Wearing Physical Activity Monitor
BEHAVIORALiSTEP
Physical Activity Intervention
Sponsors
National Institute on Aging (NIA)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity - Total Steps Recorded During 24 Weeks | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Steps Per Day During the 24-week Intervention | 24 weeks | 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. |
| C-reactive Protein | 24 weeks | 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. |
| Change in Total Cholesterol. | 24 weeks | 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. |
| Level of GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme at the Baseline Visit | 1 day 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. |
| Physical Activity - Change in Average Daily Steps Per Day Between Week 1 and Week 24 | 24 weeks | 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. |
| Association Between Physical Activity (PA) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at Baseline | 1 week | 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. |
| 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 | 24 weeks | 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. |
| Association Between Cognitive Performance (Executive Function) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at the 24-week Visit After the Intervention | 1 day at the end of the 24-week 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. |
| 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. | 24 weeks | 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. |
| Change in GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme Between the Baseline and 24-week Visit | 24 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Arm Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention.
Control Arm: Wearing Physical Activity Monitor | 32 |
| 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 | 35 |
| 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 | 33 |
| Total | 100 |
Baseline characteristics
| Characteristic | Control Arm | Total | iSTEP PA and Diet Intervention | iSTEP PA Intervention |
|---|---|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 10 | 52 years STANDARD_DEVIATION 13 | 52 years STANDARD_DEVIATION 13 | 51 years STANDARD_DEVIATION 15 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 14 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 5 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 8 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 21 Participants | 68 Participants | 26 Participants | 21 Participants |
| Region of Enrollment United States | 32 Participants | 100 Participants | 33 Participants | 35 Participants |
| Sex: Female, Male Female | 4 Participants | 14 Participants | 5 Participants | 5 Participants |
| Sex: Female, Male Male | 28 Participants | 86 Participants | 28 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 32 | 0 / 35 | 0 / 33 |
| other Total, other adverse events | 9 / 32 | 10 / 35 | 12 / 33 |
| serious Total, serious adverse events | 1 / 32 | 0 / 35 | 0 / 33 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm | Physical Activity - Total Steps Recorded During 24 Weeks | 1345700 steps | Standard Deviation 99288 |
| iSTEP PA Intervention | Physical Activity - Total Steps Recorded During 24 Weeks | 1686395 steps | Standard Deviation 187679 |
| iSTEP PA and Diet Intervention | Physical Activity - Total Steps Recorded During 24 Weeks | 1684843 steps | Standard Deviation 137606 |
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.
Time frame: 1 day at the end of the 24-week intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | Association Between Cognitive Performance (Executive Function) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at the 24-week Visit After the Intervention | 0.332 Pearson's r |
| iSTEP PA Intervention | Association Between Cognitive Performance (Executive Function) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at the 24-week Visit After the Intervention | 0.226 Pearson's r |
| iSTEP PA and Diet Intervention | Association Between Cognitive Performance (Executive Function) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at the 24-week Visit After the Intervention | 0.213 Pearson's r |
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.
Time frame: 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | Association Between Physical Activity (PA) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at Baseline | -0.175 Pearson's r |
| iSTEP PA Intervention | Association Between Physical Activity (PA) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at Baseline | -4.06 Pearson's r |
| iSTEP PA and Diet Intervention | Association Between Physical Activity (PA) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at Baseline | -0.05 Pearson's r |
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.
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | 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. | -0.401 Pearson's r |
| iSTEP PA 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. | -0.422 Pearson's r |
| iSTEP PA and Diet 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. | 0.174 Pearson's r |
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.
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | 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 | -0.354 Pearson's r |
| iSTEP PA Intervention | 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 | 0.147 Pearson's r |
| iSTEP PA and Diet Intervention | 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 | 0.363 Pearson's r |
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.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm | Average Steps Per Day During the 24-week Intervention | 8081 steps/day | Standard Error 588 |
| iSTEP PA Intervention | Average Steps Per Day During the 24-week Intervention | 10850 steps/day | Standard Error 1179 |
| iSTEP PA and Diet Intervention | Average Steps Per Day During the 24-week Intervention | 10015 steps/day | Standard Error 787 |
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.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm | Change in GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme Between the Baseline and 24-week Visit | 14497 pg/ml | Standard Error 12720 |
| iSTEP PA Intervention | Change in GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme Between the Baseline and 24-week Visit | -36496 pg/ml | Standard Error 21248 |
| iSTEP PA and Diet Intervention | Change in GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme Between the Baseline and 24-week Visit | 29674 pg/ml | Standard Error 15927 |
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.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm | Change in Total Cholesterol. | 2.14 mg/dL | Standard Error 4.56 |
| iSTEP PA Intervention | Change in Total Cholesterol. | 17.83 mg/dL | Standard Error 11.77 |
| iSTEP PA and Diet Intervention | Change in Total Cholesterol. | 10.04 mg/dL | Standard Error 4.72 |
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.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm | C-reactive Protein | -289405 pg/ml | Standard Error 682583 |
| iSTEP PA Intervention | C-reactive Protein | -63545 pg/ml | Standard Error 603429 |
| iSTEP PA and Diet Intervention | C-reactive Protein | -239997 pg/ml | Standard Error 729441 |
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.
Time frame: 1 day baseline visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm | Level of GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme at the Baseline Visit | 190278 pg/ml | Standard Error 12179 |
| iSTEP PA Intervention | Level of GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme at the Baseline Visit | 196997 pg/ml | Standard Error 17343 |
| iSTEP PA and Diet Intervention | Level of GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme at the Baseline Visit | 168417 pg/ml | Standard Error 13811 |
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.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Arm | Physical Activity - Change in Average Daily Steps Per Day Between Week 1 and Week 24 | -1504 steps/day | Standard Error 620 |
| iSTEP PA Intervention | Physical Activity - Change in Average Daily Steps Per Day Between Week 1 and Week 24 | 1667 steps/day | Standard Error 1086 |
| iSTEP PA and Diet Intervention | Physical Activity - Change in Average Daily Steps Per Day Between Week 1 and Week 24 | -685 steps/day | Standard Error 921 |