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

Browse trials for

• Acquired Immunodeficiency Syndrome 2,040
• HIV Infections 4,258

Keywords

• physical activity
• diet
• mHealth
• Fitbit
• neurocognition
• text messaging

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 100 is close to the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Study arms

• Active comparator
  Control Arm

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

  Behavioral: Control Arm

• Experimental
  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.

  Behavioral: iSTEP

• Experimental
  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.

  Behavioral: iSTEP

Interventions

• BehavioralControl Arm

  Wearing Physical Activity Monitor

• BehavioraliSTEP

  Physical Activity Intervention

• BehavioraliSTEP

  Physical Activity and Diet Intervention

Primary outcomes

1. 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

Secondary outcomes

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

Baseline characteristics

Publications

• 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. PubMed 30669986 ↗

Study documents

• Protocol and statistical analysis plan · Dec 1, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No