Trial Outcomes & Findings for I-STAND R21: Reducing Sedentary Time in Older Adults (NCT NCT02692560)
NCT ID: NCT02692560
Last Updated: 2018-06-29
Results Overview
Average hours of sitting time over the last 7 days measured at baseline and 12 weeks later
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-06-29
Participant Flow
Participant milestones
| Measure |
I-STAND
Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.
I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.
|
Healthy Living
Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.
Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
31
|
|
Overall Study
COMPLETED
|
29
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
Reasons for withdrawal
| Measure |
I-STAND
Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.
I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.
|
Healthy Living
Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.
Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
6
|
Baseline Characteristics
I-STAND R21: Reducing Sedentary Time in Older Adults
Baseline characteristics by cohort
| Measure |
I-STAND
n=29 Participants
Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.
I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.
|
Healthy Living
n=31 Participants
Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.
Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.0 years
STANDARD_DEVIATION 4.7 • n=39 Participants
|
67.8 years
STANDARD_DEVIATION 5.2 • n=41 Participants
|
68.4 years
STANDARD_DEVIATION 4.9 • n=35 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
41 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=39 Participants
|
29 Participants
n=41 Participants
|
57 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
51 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=39 Participants
|
31 Participants
n=41 Participants
|
60 Participants
n=35 Participants
|
|
Body mass index
|
36.6 kg/m^2
STANDARD_DEVIATION 6.1 • n=39 Participants
|
36.0 kg/m^2
STANDARD_DEVIATION 3.8 • n=41 Participants
|
36.3 kg/m^2
STANDARD_DEVIATION 5 • n=35 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 6 Healthy Living participants withdrew before completing the study
Average hours of sitting time over the last 7 days measured at baseline and 12 weeks later
Outcome measures
| Measure |
I-STAND
n=29 Participants
Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.
I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.
|
Healthy Living
n=25 Participants
Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.
Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.
|
|---|---|---|
|
Change in Hours of Sitting Time
|
-70.1 minutes
Standard Deviation 104
|
6.5 minutes
Standard Deviation 69
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 6 Healthy Living participants withdrew before completing the study
Change in average daily number of activPAL-measured sit-to-stand transitions, from baseline to 12 weeks
Outcome measures
| Measure |
I-STAND
n=29 Participants
Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.
I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.
|
Healthy Living
n=25 Participants
Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.
Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.
|
|---|---|---|
|
Sit-to-stand Transitions
|
-0.1 transitions
Standard Deviation 10.4
|
2.2 transitions
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 6 Healthy Living participants withdrew before completing the study
Change in average daily number of activPAL-measured periods of sitting for 30+ minutes without standing, from baseline to 12 weeks
Outcome measures
| Measure |
I-STAND
n=29 Participants
Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.
I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.
|
Healthy Living
n=25 Participants
Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.
Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.
|
|---|---|---|
|
Periods of Sitting for 30+ Minutes
|
-2.5 bouts
Standard Deviation 3.6
|
0.1 bouts
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 6 Healthy Living participants withdrew before completing the study
Change in Short Physical Performance Battery (SPPB) scale score, from baseline to 12 weeks. The range of scores is 0 to 12, higher values represent better physical function.
Outcome measures
| Measure |
I-STAND
n=29 Participants
Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.
I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.
|
Healthy Living
n=25 Participants
Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.
Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.
|
|---|---|---|
|
Physical Function
|
-0.5 units on a scale
Standard Deviation 2.2
|
0.2 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 6 Healthy Living participants withdrew before completing the study
Change in average of second and third blood pressure reading (for systolic blood pressure), from baseline to 12 weeks
Outcome measures
| Measure |
I-STAND
n=29 Participants
Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.
I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.
|
Healthy Living
n=25 Participants
Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.
Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.
|
|---|---|---|
|
Blood Pressure (Systolic Blood Pressure)
|
-3.4 mmHg
Standard Deviation 15.7
|
-1.5 mmHg
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 6 Healthy Living participants withdrew before completing the study
Change in fasting glucose (mg/dL) from finger stick blood draw, from baseline to 12 weeks
Outcome measures
| Measure |
I-STAND
n=29 Participants
Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.
I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.
|
Healthy Living
n=25 Participants
Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.
Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.
|
|---|---|---|
|
Fasting Glucose (mg/dL)
|
8.8 mg/dL
Standard Deviation 30.6
|
2.4 mg/dL
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 6 Healthy Living participants withdrew before completing the study
Change in total cholesterol (mg/dL) from finger stick blood draw, from baseline to 12 weeks
Outcome measures
| Measure |
I-STAND
n=29 Participants
Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.
I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.
|
Healthy Living
n=25 Participants
Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.
Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.
|
|---|---|---|
|
Total Cholesterol (mg/dL)
|
6.0 mg/dL
Standard Deviation 21.5
|
0.4 mg/dL
Standard Deviation 28.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 6 Healthy Living participants withdrew before completing the study
Change in Patient Health Questionnaire (PHQ-8) scale score, from baseline to 12 weeks. The scale range is 0 to 24 with higher scores representing higher depressive symptoms. Scores of 10 or more are considered major depression.
Outcome measures
| Measure |
I-STAND
n=29 Participants
Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.
I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.
|
Healthy Living
n=25 Participants
Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.
Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.
|
|---|---|---|
|
Depressive Symptoms
|
-1.0 units on a scale
Standard Deviation 2.3
|
-0.6 units on a scale
Standard Deviation 2.5
|
Adverse Events
I-STAND
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Healthy Living
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
I-STAND
n=29 participants at risk
Participants randomly assigned to the I-STAND intervention group will receive 2 in-person health coaching sessions and 4 biweekly phone-based health coaching sessions. They will receive a wristband that gives a mild vibration after 20 minutes of inactivity and will be encouraged to stand if possible after each inactivity alert. Participants may also choose to receive biweekly email reminders in the weeks between coaching calls. They will also receive a workbook with content around reducing sitting time.
I-STAND: Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.
|
Healthy Living
n=31 participants at risk
Participants randomly assigned to the Healthy Living enhanced usual care control group will receive 1 in-person health coaching session and 5 biweekly check-in letters by mail. They will receive a workbook with general healthy living topics that are not expected to impact sitting time. All content is taken from Kaiser Permanente Washington's website and is available to all members. Participants will select topics of interest and review them on their own with no further health coaching.
Healthy Living: Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Mild irritation from thigh-worn measurement device adhesive
|
3.4%
1/29 • Number of events 2 • Adverse event data were collected for the duration of study enrollment (12 months total across all participants).
We systematically assessed for adverse events by asking for health changes/events at each study contact point.
|
0.00%
0/31 • Adverse event data were collected for the duration of study enrollment (12 months total across all participants).
We systematically assessed for adverse events by asking for health changes/events at each study contact point.
|
|
Skin and subcutaneous tissue disorders
Mild irritation from wrist-worn prompting device
|
10.3%
3/29 • Number of events 3 • Adverse event data were collected for the duration of study enrollment (12 months total across all participants).
We systematically assessed for adverse events by asking for health changes/events at each study contact point.
|
0.00%
0/31 • Adverse event data were collected for the duration of study enrollment (12 months total across all participants).
We systematically assessed for adverse events by asking for health changes/events at each study contact point.
|
Additional Information
Dori Rosenberg, PhD, MPH
Kaiser Permanente Washington Health Research Institute
Phone: 206-287-2532
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place