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The investigators are doing a study to learn how to support patients aged 60+ in taking more breaks from sitting and reducing total sitting time. The goal of the study is to find out if a sitting time reduction intervention reduces sitting time compared with a control group.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-STAND | Experimental | 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. |
|
| Healthy Living | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I-STAND | Behavioral | Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hours of Sitting Time | Average hours of sitting time over the last 7 days measured at baseline and 12 weeks later | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sit-to-stand Transitions | Change in average daily number of activPAL-measured sit-to-stand transitions, from baseline to 12 weeks | 12 weeks |
| Periods of Sitting for 30+ Minutes | Change in average daily number of activPAL-measured periods of sitting for 30+ minutes without standing, from baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dori E Rosenberg, PhD, MPH | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Washington Health Research Institute | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29879948 | Derived | Matson TE, Renz AD, Takemoto ML, McClure JB, Rosenberg DE. Acceptability of a sitting reduction intervention for older adults with obesity. BMC Public Health. 2018 Jun 7;18(1):706. doi: 10.1186/s12889-018-5616-1. | |
| 29434012 | Derived | Rosenberg DE, Lee AK, Anderson M, Renz A, Matson TE, Kerr J, Arterburn D, McClure JB. Reducing Sedentary Time for Obese Older Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Feb 12;7(2):e23. doi: 10.2196/resprot.8883. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hours of Sitting Time | Average hours of sitting time over the last 7 days measured at baseline and 12 weeks later | 6 Healthy Living participants withdrew before completing the study | Posted | Mean | Standard Deviation | minutes | 12 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild irritation from thigh-worn measurement device adhesive | Skin and subcutaneous tissue disorders | Systematic Assessment | 1 participant reported mild skin irritation from the adhesive used with the thigh-worn activity monitor during two periods of wear. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dori Rosenberg, PhD, MPH | Kaiser Permanente Washington Health Research Institute | 206-287-2532 | rosenberg.d@ghc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 12, 2018 | May 29, 2018 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 12, 2018 | May 29, 2018 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Healthy Living | Other | Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees. |
|
| 12 weeks |
| Physical Function | 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. | 12 weeks |
| Blood Pressure (Systolic Blood Pressure) | Change in average of second and third blood pressure reading (for systolic blood pressure), from baseline to 12 weeks | 12 weeks |
| Fasting Glucose (mg/dL) | Change in fasting glucose (mg/dL) from finger stick blood draw, from baseline to 12 weeks | 12 weeks |
| Total Cholesterol (mg/dL) | Change in total cholesterol (mg/dL) from finger stick blood draw, from baseline to 12 weeks | 12 weeks |
| Depressive Symptoms | 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. | 12 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | 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. |
|
|
| Secondary | Sit-to-stand Transitions | Change in average daily number of activPAL-measured sit-to-stand transitions, from baseline to 12 weeks | 6 Healthy Living participants withdrew before completing the study | Posted | Mean | Standard Deviation | transitions | 12 weeks |
|
|
|
| Secondary | Periods of Sitting for 30+ Minutes | Change in average daily number of activPAL-measured periods of sitting for 30+ minutes without standing, from baseline to 12 weeks | 6 Healthy Living participants withdrew before completing the study | Posted | Mean | Standard Deviation | bouts | 12 weeks |
|
|
|
| Secondary | Physical Function | 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. | 6 Healthy Living participants withdrew before completing the study | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Secondary | Blood Pressure (Systolic Blood Pressure) | Change in average of second and third blood pressure reading (for systolic blood pressure), from baseline to 12 weeks | 6 Healthy Living participants withdrew before completing the study | Posted | Mean | Standard Deviation | mmHg | 12 weeks |
|
|
|
| Secondary | Fasting Glucose (mg/dL) | Change in fasting glucose (mg/dL) from finger stick blood draw, from baseline to 12 weeks | 6 Healthy Living participants withdrew before completing the study | Posted | Mean | Standard Deviation | mg/dL | 12 weeks |
|
|
|
| Secondary | Total Cholesterol (mg/dL) | Change in total cholesterol (mg/dL) from finger stick blood draw, from baseline to 12 weeks | 6 Healthy Living participants withdrew before completing the study | Posted | Mean | Standard Deviation | mg/dL | 12 weeks |
|
|
|
| Secondary | Depressive Symptoms | 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. | 6 Healthy Living participants withdrew before completing the study | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 4 |
| 29 |
| EG001 | 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. | 0 | 31 | 0 | 31 | 0 | 31 |
|
| Mild irritation from wrist-worn prompting device | Skin and subcutaneous tissue disorders | Systematic Assessment | 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. |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |