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
|Condition or disease||Intervention/treatment||Phase|
|Obesity Sedentary Lifestyle||Behavioral: I-STAND Other: Healthy Living||Not Applicable|
More than one-third of American adults over 60 have a body mass index > 30 kg/m2. These older adults have more sedentary time than any other group -- an average of 10-11 hours per day. Reducing the sedentary behavior of older adults with obesity, rather than only promoting more intensive physical activity, could provide a more feasible approach to health promotion.
This randomized control pilot trial will evaluate a 12-week intervention to decrease sitting time and increase standing time and light physical activity among sedentary older adults a body mass index > 30 kg/m2 as compared to control group. Baseline and 12-week measurements include anthropometric measures, blood draw by finger stick, cardiovascular health assessments, physical function tasks, and a survey. The intervention will consist of two in-person visits with a health coach followed by phone-based coaching.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Take Active Breaks From Sitting (TABS): Reducing Sedentary Time in Older Adults|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
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.
Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.
Active Comparator: 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.
Other: 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 [ Time Frame: 12 weeks ]Average hours of sitting time over the last 7 days measured at baseline and 12 weeks later
- Sit-to-stand Transitions [ Time Frame: 12 weeks ]Change in average daily number of activPAL-measured sit-to-stand transitions, from baseline to 12 weeks
- Periods of Sitting for 30+ Minutes [ Time Frame: 12 weeks ]Change in average daily number of activPAL-measured periods of sitting for 30+ minutes without standing, from baseline to 12 weeks
- Physical Function [ Time Frame: 12 weeks ]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.
- Blood Pressure (Systolic Blood Pressure) [ Time Frame: 12 weeks ]Change in average of second and third blood pressure reading (for systolic blood pressure), from baseline to 12 weeks
- Fasting Glucose (mg/dL) [ Time Frame: 12 weeks ]Change in fasting glucose (mg/dL) from finger stick blood draw, from baseline to 12 weeks
- Total Cholesterol (mg/dL) [ Time Frame: 12 weeks ]Change in total cholesterol (mg/dL) from finger stick blood draw, from baseline to 12 weeks
- Depressive Symptoms [ Time Frame: 12 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692560
|United States, Washington|
|Kaiser Permanente Washington Health Research Institute|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Dori E Rosenberg, PhD, MPH||Kaiser Permanente|