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I-STAND R21: Reducing Sedentary Time in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02692560
Recruitment Status : Completed
First Posted : February 26, 2016
Results First Posted : May 11, 2018
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Obesity
Sedentary Lifestyle
Interventions Behavioral: I-STAND
Other: Healthy Living
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title I-STAND Healthy Living
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 29 31
Completed 29 25
Not Completed 0 6
Reason Not Completed
Withdrawal by Subject             0             6
Arm/Group Title I-STAND Healthy Living Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 29 31 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 31 participants 60 participants
69.0  (4.7) 67.8  (5.2) 68.4  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 31 participants 60 participants
Female
20
  69.0%
21
  67.7%
41
  68.3%
Male
9
  31.0%
10
  32.3%
19
  31.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 31 participants 60 participants
Hispanic or Latino
0
   0.0%
1
   3.2%
1
   1.7%
Not Hispanic or Latino
28
  96.6%
29
  93.5%
57
  95.0%
Unknown or Not Reported
1
   3.4%
1
   3.2%
2
   3.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 31 participants 60 participants
American Indian or Alaska Native
0
   0.0%
1
   3.2%
1
   1.7%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   3.2%
1
   1.7%
Black or African American
1
   3.4%
4
  12.9%
5
   8.3%
White
28
  96.6%
23
  74.2%
51
  85.0%
More than one race
0
   0.0%
1
   3.2%
1
   1.7%
Unknown or Not Reported
0
   0.0%
1
   3.2%
1
   1.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 29 participants 31 participants 60 participants
29
 100.0%
31
 100.0%
60
 100.0%
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 29 participants 31 participants 60 participants
36.6  (6.1) 36.0  (3.8) 36.3  (5)
1.Primary Outcome
Title Change in Hours of Sitting Time
Hide Description Average hours of sitting time over the last 7 days measured at baseline and 12 weeks later
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
6 Healthy Living participants withdrew before completing the study
Arm/Group Title I-STAND Healthy Living
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 29 25
Mean (Standard Deviation)
Unit of Measure: minutes
-70.1  (104) 6.5  (69)
2.Secondary Outcome
Title Sit-to-stand Transitions
Hide Description Change in average daily number of activPAL-measured sit-to-stand transitions, from baseline to 12 weeks
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
6 Healthy Living participants withdrew before completing the study
Arm/Group Title I-STAND Healthy Living
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 29 25
Mean (Standard Deviation)
Unit of Measure: transitions
-0.1  (10.4) 2.2  (11.8)
3.Secondary Outcome
Title Periods of Sitting for 30+ Minutes
Hide Description Change in average daily number of activPAL-measured periods of sitting for 30+ minutes without standing, from baseline to 12 weeks
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
6 Healthy Living participants withdrew before completing the study
Arm/Group Title I-STAND Healthy Living
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 29 25
Mean (Standard Deviation)
Unit of Measure: bouts
-2.5  (3.6) 0.1  (2.7)
4.Secondary Outcome
Title Physical Function
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
6 Healthy Living participants withdrew before completing the study
Arm/Group Title I-STAND Healthy Living
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 29 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.5  (2.2) 0.2  (1.2)
5.Secondary Outcome
Title Blood Pressure (Systolic Blood Pressure)
Hide Description Change in average of second and third blood pressure reading (for systolic blood pressure), from baseline to 12 weeks
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
6 Healthy Living participants withdrew before completing the study
Arm/Group Title I-STAND Healthy Living
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 29 25
Mean (Standard Deviation)
Unit of Measure: mmHg
-3.4  (15.7) -1.5  (13.8)
6.Secondary Outcome
Title Fasting Glucose (mg/dL)
Hide Description Change in fasting glucose (mg/dL) from finger stick blood draw, from baseline to 12 weeks
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
6 Healthy Living participants withdrew before completing the study
Arm/Group Title I-STAND Healthy Living
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 29 25
Mean (Standard Deviation)
Unit of Measure: mg/dL
8.8  (30.6) 2.4  (10.3)
7.Secondary Outcome
Title Total Cholesterol (mg/dL)
Hide Description Change in total cholesterol (mg/dL) from finger stick blood draw, from baseline to 12 weeks
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
6 Healthy Living participants withdrew before completing the study
Arm/Group Title I-STAND Healthy Living
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 29 25
Mean (Standard Deviation)
Unit of Measure: mg/dL
6.0  (21.5) 0.4  (28.0)
8.Secondary Outcome
Title Depressive Symptoms
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
6 Healthy Living participants withdrew before completing the study
Arm/Group Title I-STAND Healthy Living
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 29 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.0  (2.3) -0.6  (2.5)
Time Frame Adverse event data were collected for the duration of study enrollment (12 months total across all participants).
Adverse Event Reporting Description We systematically assessed for adverse events by asking for health changes/events at each study contact point.
 
Arm/Group Title I-STAND Healthy Living
Hide Arm/Group Description

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.

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.

All-Cause Mortality
I-STAND Healthy Living
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)      0/31 (0.00%)    
Hide Serious Adverse Events
I-STAND Healthy Living
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      0/31 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
I-STAND Healthy Living
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/29 (13.79%)      0/31 (0.00%)    
Skin and subcutaneous tissue disorders     
Mild irritation from thigh-worn measurement device adhesive  [1]  1/29 (3.45%)  2 0/31 (0.00%)  0
Mild irritation from wrist-worn prompting device  [2]  3/29 (10.34%)  3 0/31 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
1 participant reported mild skin irritation from the adhesive used with the thigh-worn activity monitor during two periods of wear.
[2]
3 participants reported mild skin irritation from wearing the wrist-worn prompting device. They discontinued using it or wore it differently and no longer experienced issues.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dori Rosenberg, PhD, MPH
Organization: Kaiser Permanente Washington Health Research Institute
Phone: 206-287-2532
EMail: rosenberg.d@ghc.org
Layout table for additonal information
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02692560    
Other Study ID Numbers: 1R21AG043853 ( U.S. NIH Grant/Contract )
First Submitted: February 24, 2016
First Posted: February 26, 2016
Results First Submitted: February 22, 2018
Results First Posted: May 11, 2018
Last Update Posted: June 29, 2018