Trial Outcomes & Findings for iSTEP - an mHealth Physical Activity and Diet Intervention for Persons With HIV (NCT NCT03123731)

NCT ID: NCT03123731

Last Updated: 2024-09-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	Control Arm Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: 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. iSTEP: 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. iSTEP: Physical Activity and Diet Intervention
Overall Study STARTED	32	35	33
Overall Study COMPLETED	23	21	26
Overall Study NOT COMPLETED	9	14	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Control Arm n=32 Participants Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: Wearing Physical Activity Monitor	iSTEP PA Intervention n=35 Participants 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	iSTEP PA and Diet Intervention n=33 Participants 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	Total n=100 Participants Total of all reporting groups
Age, Continuous	54 years STANDARD_DEVIATION 10 • n=5 Participants	51 years STANDARD_DEVIATION 15 • n=7 Participants	52 years STANDARD_DEVIATION 13 • n=5 Participants	52 years STANDARD_DEVIATION 13 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	30 Participants n=7 Participants	28 Participants n=5 Participants	86 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	21 Participants n=7 Participants	26 Participants n=5 Participants	68 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Region of Enrollment United States	32 Participants n=5 Participants	35 Participants n=7 Participants	33 Participants n=5 Participants	100 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	iSTEP PA Intervention n=24 Participants 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	iSTEP PA and Diet Intervention n=27 Participants 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	Control Arm n=25 Participants Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: Wearing Physical Activity Monitor
Physical Activity - Total Steps Recorded During 24 Weeks	1686395 steps Standard Deviation 187679	1684843 steps Standard Deviation 137606	1345700 steps Standard Deviation 99288

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	iSTEP PA Intervention n=19 Participants 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	iSTEP PA and Diet Intervention n=25 Participants 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	Control Arm n=23 Participants Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: Wearing Physical Activity Monitor
Physical Activity - Change in Average Daily Steps Per Day Between Week 1 and Week 24	1667 steps/day Standard Error 1086	-685 steps/day Standard Error 921	-1504 steps/day Standard Error 620

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	iSTEP PA Intervention n=22 Participants 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	iSTEP PA and Diet Intervention n=27 Participants 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	Control Arm n=24 Participants Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: Wearing Physical Activity Monitor
Average Steps Per Day During the 24-week Intervention	10850 steps/day Standard Error 1179	10015 steps/day Standard Error 787	8081 steps/day Standard Error 588

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	iSTEP PA Intervention n=13 Participants 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	iSTEP PA and Diet Intervention n=17 Participants 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	Control Arm n=18 Participants Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: Wearing Physical Activity Monitor
C-reactive Protein	-63545 pg/ml Standard Error 603429	-239997 pg/ml Standard Error 729441	-289405 pg/ml Standard Error 682583

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	iSTEP PA Intervention n=18 Participants 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	iSTEP PA and Diet Intervention n=21 Participants 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	Control Arm n=21 Participants Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: Wearing Physical Activity Monitor
Change in Total Cholesterol.	17.83 mg/dL Standard Error 11.77	10.04 mg/dL Standard Error 4.72	2.14 mg/dL Standard Error 4.56

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	iSTEP PA Intervention n=12 Participants 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	iSTEP PA and Diet Intervention n=20 Participants 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	Control Arm n=19 Participants Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: Wearing Physical Activity Monitor
Level of GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme at the Baseline Visit	196997 pg/ml Standard Error 17343	168417 pg/ml Standard Error 13811	190278 pg/ml Standard Error 12179

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	iSTEP PA Intervention n=11 Participants 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	iSTEP PA and Diet Intervention n=20 Participants 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	Control Arm n=19 Participants Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: Wearing Physical Activity Monitor
Change in GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase D) Enzyme Between the Baseline and 24-week Visit	-36496 pg/ml Standard Error 21248	29674 pg/ml Standard Error 15927	14497 pg/ml Standard Error 12720

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	iSTEP PA Intervention n=14 Participants 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	iSTEP PA and Diet Intervention n=20 Participants 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	Control Arm n=19 Participants Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: Wearing Physical Activity Monitor
Association Between Physical Activity (PA) and GPLD1 (Phosphatidylinositol-glycan-specific Phospholipase d) at Baseline	-4.06 Pearson's r	-0.05 Pearson's r	-0.175 Pearson's r

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	iSTEP PA Intervention n=13 Participants 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	iSTEP PA and Diet Intervention n=19 Participants 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	Control Arm n=19 Participants Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: Wearing Physical Activity Monitor
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	0.363 Pearson's r	-0.354 Pearson's r

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	iSTEP PA Intervention n=14 Participants 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	iSTEP PA and Diet Intervention n=19 Participants 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	Control Arm n=20 Participants Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: Wearing Physical Activity Monitor
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	0.213 Pearson's r	0.332 Pearson's r

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	iSTEP PA Intervention n=13 Participants 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	iSTEP PA and Diet Intervention n=17 Participants 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	Control Arm n=18 Participants Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: Wearing Physical Activity Monitor
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	0.174 Pearson's r	-0.401 Pearson's r

Adverse Events

Control Arm

Serious events: 1 serious events

Other events: 9 other events

Deaths: 1 deaths

iSTEP PA Intervention

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

iSTEP PA and Diet Intervention

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control Arm n=32 participants at risk Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: Wearing Physical Activity Monitor	iSTEP PA Intervention n=35 participants at risk 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	iSTEP PA and Diet Intervention n=33 participants at risk 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
Vascular disorders Myocardial infarction	3.1% 1/32 • Number of events 1 • Adverse events were monitored during the 24-week (6-month) study intervention for each participant.	0.00% 0/35 • Adverse events were monitored during the 24-week (6-month) study intervention for each participant.	0.00% 0/33 • Adverse events were monitored during the 24-week (6-month) study intervention for each participant.

Other adverse events

Measure	Control Arm n=32 participants at risk Participants will wear a Fitbit but will not receive any additional elements of the iSTEP intervention. Control Arm: Wearing Physical Activity Monitor	iSTEP PA Intervention n=35 participants at risk 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	iSTEP PA and Diet Intervention n=33 participants at risk 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
Musculoskeletal and connective tissue disorders minor muscle soreness	28.1% 9/32 • Number of events 9 • Adverse events were monitored during the 24-week (6-month) study intervention for each participant.	28.6% 10/35 • Number of events 10 • Adverse events were monitored during the 24-week (6-month) study intervention for each participant.	36.4% 12/33 • Number of events 14 • Adverse events were monitored during the 24-week (6-month) study intervention for each participant.

Additional Information

Dr. Brook Henry

University of California, San Diego

Phone: 619-543-4737

Email: blhenry@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place