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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL132880-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Healthy Aging Resources to Thrive (HART) uses a rigorous two-stage randomized control design, adapted and refined based on pilot studies, to test a novel intervention to reduce sitting time in older adults. Half the participants will be randomized to the intervention aimed at decreasing sitting time, and the other half will be randomized to a healthy living control that does not focus on reduced sitting time. After 6 months, the intervention group will be further randomized so that half continue with the intervention and the other half receive no further intervention. All participants will be followed for 12 months.
Healthy Aging Resources to Thrive (HART) is a two-stage randomized controlled trial (RCT) of adults over age 60 with obesity to determine the efficacy of a novel sitting-reduction intervention and its impact on cardiometabolic risk markers. Participants will be randomized to a 6-month sitting reduction intervention (termed I-STAND) or healthy-living attention control (Stage 1). All participants will be mailed a scale and a blood pressure monitor (to keep) which will be used during the phone-based measurement visits at Baseline, 3, 6 and 12 months. All participants will have phone-based Coaching sessions.
After 6 months, I-STAND participants will be re-randomized to receive either booster sessions or no further intervention (Stage 2). Attention control participants will receive no further intervention. All participants will be followed for 12 months total with phone-based assessments at baseline, 3, 6, and 12 months. Primary outcomes are reduction in sitting time at 6 months, objectively measured using the activPAL device, and blood pressure. The design will answer novel questions about the impact of sitting reduction on cardiometabolic risk markers as well as maintenance of sitting reduction.
UPDATE: As of 3/31/31, (final year 5) of the study, participants randomized to the i-STAND intervention will no longer be re-randomized at 6 months. We will no longer follow participants to the 12-month timepoint & will end all activities after 6-months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| i-STAND | Experimental | i-STAND participants have a Baseline visit followed by the 1st Coaching visit. They receive wristbands that vibrate every 15 minutes to prompt a standing break, standing desks, workbook & 10 phone-based coaching calls focused on sitting less/standing more. There is a 3 month measurement visit. Program ends at 6 months when they wear an activPAL & have a measurement visit. Coach provides feedback on activPAL sitting time after all activPAL wears (Bsln, 3, 6 & 12 month). They may opt to wear activPAL at 6 weeks & get feedback. They are re-randomized at 6 months; half to be assigned to intervention boosters (5 more phone sessions/a 9-month optional activPAL) before the 12 month final activPAL & final measurement visit. Those not randomized to boosters will have no contact until the 12 month visit. UPDATE: As of 3/31/2022, (final year 5), i-STAND ppts will no longer be re-randomized at 6 months. We will no longer follow to the 12-month timepoint & will end all activities after 6-months. |
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| Healthy Living control | Active Comparator | In this arm, participants have a phone-based Baseline visit followed by the 1st phone-based Coaching visit. No prompting devices/desks are offered; coaching focuses on topics related to healthy living, but with no focus on sitting less/standing more. They have 10 phone calls with a health coach. Participants receive a workbook. All content is from KaiserPermanente WA and is available to all members. Participants select topics & review them with their health coach. At 3 months, participants have a measurement visit. The program ends at 6 months where participants will wear an activPAL and have a measurement visit. After that, there is no contact with the study team until 12 months when they will again wear an activPAL & have a final measurement visit. UPDATE: As of 3/31/2022, our final year (year 5) of the study, participants randomized to the control arm will no longer be followed to the 12-month timepoint and will end all activities after the 6-month timepoint. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| i-STAND | Behavioral | Via in-person and phone coaching sessions, participants randomized to this arm will be coached to find ways to sit less and stand more, and look for ways to change their home environment to encourage this, as well as look at how their lifestyle may contribute to their sitting time. Participants in this arm may be re-randomized at the half-way point to continue with additional phone coaching sessions. (As of 3/31/2022 Re-randomizations are no longer taking place) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Time Spent Sitting or Lying Down at 6 Months | Time (minutes) spent sitting/lying during waking hours will be measured objectively by the activPAL worn for one week following each measurement visit. | Change from Baseline at 6 months |
| Change in SystolicBlood Pressure at 6 Months | Another primary outcome is change in systolic blood pressure. This will be measured at the measurement visits using blood pressure monitors mailed to the participant | Change from Baseline at 6 months |
| Change in Diastolic Blood Pressure at 6 Months | Another primary outcome is change in diastolic blood pressure | Change from Baseline at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight at 6 Months | Participants provide their weight at each measurement visit. Weight is measured in pounds using a scale mailed to the participant. | Change from Baseline at 6 months |
| Change in BMI at 6 Months |
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Inclusion Criteria: • Self-reported sitting time of 6+ hours per day
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 | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34666182 | Background | Rosenberg DE, Greenwood-Hickman MA, Zhou J, Cook AJ, Mettert KD, Cooper J, Arterburn D, Green BB, Walsh-Bailey C, Kerr J, Owen N, Dunstan D, McClure JB. Protocol for a randomized controlled trial of sitting reduction to improve cardiometabolic health in older adults. Contemp Clin Trials. 2021 Dec;111:106593. doi: 10.1016/j.cct.2021.106593. Epub 2021 Oct 16. | |
| 34095079 | Background | Greenwood-Hickman MA, Dahlquist J, Cooper J, Holden E, McClure JB, Mettert KD, Perry SR, Rosenberg DE. "They're Going to Zoom It": A Qualitative Investigation of Impacts and Coping Strategies During the COVID-19 Pandemic Among Older Adults. Front Public Health. 2021 May 19;9:679976. doi: 10.3389/fpubh.2021.679976. eCollection 2021. |
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We had 11 participants consent* to the study but who were never randomized thus *not enrolled*. Of these, 3 completed a baseline visit but before randomization, 2 never responded to our attempts to reach them (5 calls and one letter) and 1 said they were too busy to continue. The remaining 8 were non responsive to our attempts to reach them after initial consent.
All of these participants were remote and thus their randomization took place up to 2 weeks after the baseline visit.
Goal was 284 randomized participants. A total of 357 potential participants were recruited, with 283 consenting and completing baseline measurements and randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | i-STAND | i-STAND participants have a Baseline visit followed by the 1st Coaching visit. They receive wristbands that vibrate every 15 minutes to prompt a standing break, standing desks, workbook & 10 phone-based coaching calls focused on sitting less/standing more. There is a 3 month measurement visit. Program ends at 6 months when they wear an activPAL & have a measurement visit. Coach provides feedback on activPAL sitting time after all activPAL wears (Bsln, 3, 6 & 12 month). They may opt to wear activPAL at 6 weeks & get feedback. They are re-randomized at 6 months; half to be assigned to intervention boosters (5 more phone sessions/a 9-month optional activPAL) before the 12 month final activPAL & final measurement visit. Those not randomized to boosters will have no contact until the 12 month visit. UPDATE: As of 3/31/2022, (final year 5), i-STAND ppts will no longer be re-randomized at 6 months. We will no longer follow to the 12-month timepoint & will end all activities after 6-months. i-STAND: Via in-person and phone coaching sessions, participants randomized to this arm will be coached to find ways to sit less and stand more, and look for ways to change their home environment to encourage this, as well as look at how their lifestyle may contribute to their sitting time. Participants in this arm may be re-randomized at the half-way point to continue with additional phone coaching sessions. (As of 3/31/2022 Re-randomizations are no longer taking place) |
| FG001 | Healthy Living Control | In this arm, participants have a phone-based Baseline visit followed by the 1st phone-based Coaching visit. No prompting devices/desks are offered; coaching focuses on topics related to healthy living, but with no focus on sitting less/standing more. They have 10 phone calls with a health coach. Participants receive a workbook. All content is from KaiserPermanente WA and is available to all members. Participants select topics & review them with their health coach. At 3 months, participants have a measurement visit. The program ends at 6 months where participants will wear an activPAL and have a measurement visit. After that, there is no contact with the study team until 12 months when they will again wear an activPAL & have a final measurement visit. UPDATE: As of 3/31/2022, our final year (year 5) of the study, participants randomized to the control arm will no longer be followed to the 12-month timepoint and will end all activities after the 6-month timepoint. Healthy Living control: In this arm, participants will have phone coaching sessions focused on a variety of topics aimed at improving healthy habits. There is no focus on standing more or sitting less. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | i-STAND | i-STAND participants have a Baseline visit followed by the 1st Coaching visit. They receive wristbands that vibrate every 15 minutes to prompt a standing break, standing desks, workbook & 10 phone-based coaching calls focused on sitting less/standing more. There is a 3 month measurement visit. Program ends at 6 months when they wear an activPAL & have a measurement visit. Coach provides feedback on activPAL sitting time after all activPAL wears (Bsln, 3, 6 & 12 month). They may opt to wear activPAL at 6 weeks & get feedback. They are re-randomized at 6 months; half to be assigned to intervention boosters (5 more phone sessions/a 9-month optional activPAL) before the 12 month final activPAL & final measurement visit. Those not randomized to boosters will have no contact until the 12 month visit. UPDATE: As of 3/31/2022, (final year 5), i-STAND ppts will no longer be re-randomized at 6 months. We will no longer follow to the 12-month timepoint & will end all activities after 6-months. i-STAND: Via in-person and phone coaching sessions, participants randomized to this arm will be coached to find ways to sit less and stand more, and look for ways to change their home environment to encourage this, as well as look at how their lifestyle may contribute to their sitting time. Participants in this arm may be re-randomized at the half-way point to continue with additional phone coaching sessions. (As of 3/31/2022 Re-randomizations are no longer taking place) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Time Spent Sitting or Lying Down at 6 Months | Time (minutes) spent sitting/lying during waking hours will be measured objectively by the activPAL worn for one week following each measurement visit. | Number of participants who had a 6-month measure for change in sitting time | Posted | Mean | 95% Confidence Interval | Minutes | Change from Baseline at 6 months |
|
6 months
AE data was collected at coaching calls and measurement calls no matter the relation to the study. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
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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 | i-STAND participants have a Baseline visit followed by the 1st Coaching visit. They receive wristbands that vibrate every 15 minutes to prompt a standing break, standing desks, workbook & 10 phone-based coaching calls focused on sitting less/standing more. There is a 3 month measurement visit. Program ends at 6 months when they wear an activPAL & have a measurement visit. Coach provides feedback on activPAL sitting time after all activPAL wears (Bsln, 3, 6 & 12 month). They may opt to wear activPAL at 6 weeks & get feedback. They are re-randomized at 6 months; half to be assigned to intervention boosters (5 more phone sessions/a 9-month optional activPAL) before the 12 month final activPAL & final measurement visit. Those not randomized to boosters will have no contact until the 12 month visit. UPDATE: As of 3/31/2022, (final year 5), i-STAND ppts will no longer be re-randomized at 6 months. We will no longer follow to the 12-month timepoint & will end all activities after 6-months. i-STAND: Via in-person and phone coaching sessions, participants randomized to this arm will be coached to find ways to sit less and stand more, and look for ways to change their home environment to encourage this, as well as look at how their lifestyle may contribute to their sitting time. Participants in this arm may be re-randomized at the half-way point to continue with additional phone coaching sessions. (As of 3/31/2022 Re-randomizations are no longer taking place) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrelated SAE | Blood and lymphatic system disorders | Systematic Assessment | Unrelated to study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrelated Other AE | General disorders | Systematic Assessment |
Limitations of our study include the interruption caused by the COVID-19 pandemic, which occurred after 100 of the 283 participants were enrolled. We had to rely on participant-measured outcomes post-pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dori Rosenberg, Principal Investigator | Kaiser Permanente | 206-287-2532 | dori.e.rosenberg@kp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2022 | Sep 8, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 15, 2020 | Sep 8, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Participants will be randomized into one of two cohorts/arms: one called "i-STAND" with coaching sessions focused directly on sitting less and standing more; the other called "Healthy Living" with coaching sessions focused on various topics related to a healthy lifestyle, but without a focus on standing more. Those randomized to the i-STAND intervention will also be re-randomized half-way through the study, with half of that cohort moving on to phase 2, which involves booster sessions on sitting less and standing more. All participants regardless of cohort will be mailed a blood pressure monitor and a scale to keep. UPDATE: As of March 31, 2022, beginning in our final year (year 5) of the study, participants randomized to the i-STAND intervention will no longer be re-randomized at 6 months. We will no longer follow participants to the 12-month timepoint and will end all activities after the 6-month timepoint.
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| Healthy Living control | Other | In this arm, participants will have phone coaching sessions focused on a variety of topics aimed at improving healthy habits. There is no focus on standing more or sitting less. |
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BMI was calculated as [weight in kg]/[height in m]2.
| Change from Baseline at 6 months |
| Change in Waist Circumference at 6 Months | Participants provided their waist circumference at each measurement visit. Waist circumference was measured at the superior border of the iliac crest. | Change from Baseline at 6 months |
| 35506125 | Result | Greenwood-Hickman MA, Zhou J, Cook A, Mettert KD, Green B, McClure J, Arterburn D, Florez-Acevedo S, Rosenberg DE. Exploring Differences in Older Adult Accelerometer-Measured Sedentary Behavior and Resting Blood Pressure Before and During the COVID-19 Pandemic. Gerontol Geriatr Med. 2022 Apr 27;8:23337214221096007. doi: 10.1177/23337214221096007. eCollection 2022 Jan-Dec. |
| 38536177 | Result | Rosenberg DE, Zhu W, Greenwood-Hickman MA, Cook AJ, Florez Acevedo S, McClure JB, Arterburn DE, Cooper J, Owen N, Dunstan D, Perry SR, Yarborough L, Mettert KD, Green BB. Sitting Time Reduction and Blood Pressure in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e243234. doi: 10.1001/jamanetworkopen.2024.3234. |
| 41223847 | Derived | Florez-Acevedo S, Greenwood-Hickman MA, Zhu W, Cook AJ, Delaney K, Green BB, Arterburn DE, McClure JB, Rosenberg DE. Exploratory Analysis of Mental Health and Quality of Life Outcomes in a Randomized Controlled Trial to Reduce Sitting Time in Older Adults With Obesity. J Aging Phys Act. 2025 Nov 12:1-12. doi: 10.1123/japa.2024-0387. Online ahead of print. |
| BG001 | Healthy Living Control | In this arm, participants have a phone-based Baseline visit followed by the 1st phone-based Coaching visit. No prompting devices/desks are offered; coaching focuses on topics related to healthy living, but with no focus on sitting less/standing more. They have 10 phone calls with a health coach. Participants receive a workbook. All content is from KaiserPermanente WA and is available to all members. Participants select topics & review them with their health coach. At 3 months, participants have a measurement visit. The program ends at 6 months where participants will wear an activPAL and have a measurement visit. After that, there is no contact with the study team until 12 months when they will again wear an activPAL & have a final measurement visit. UPDATE: As of 3/31/2022, our final year (year 5) of the study, participants randomized to the control arm will no longer be followed to the 12-month timepoint and will end all activities after the 6-month timepoint. Healthy Living control: In this arm, participants will have phone coaching sessions focused on a variety of topics aimed at improving healthy habits. There is no focus on standing more or sitting less. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Pre-pandemic participants were recruited from King County, WA. With the onset of the pandemic and the switch to a 100% remote study, we expanded statewide. | Count of Participants | Participants |
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| Baseline Measure of Time Spent Sitting or Lying Down | Baseline sitting time in minutes was measured using the activPAL device (does not include sleep time). | We had missing data for baseline sitting time: 2 in the intervention group and 4 in the control group. | Mean | Standard Deviation | Minutes |
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| Baseline Measure of Systolic Blood Pressure mmHg | We had missing SBP for 1 participant in the baseline control group | Mean | Standard Deviation | mmHg |
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| Baseline measure of Diastolic Blood Pressure mmHg | We had missing DBP for 1 participant in the baseline control group | Mean | Standard Deviation | mmHg |
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| OG001 | Healthy Living Control | In this arm, participants have a phone-based Baseline visit followed by the 1st phone-based Coaching visit. No prompting devices/desks are offered; coaching focuses on topics related to healthy living, but with no focus on sitting less/standing more. They have 10 phone calls with a health coach. Participants receive a workbook. All content is from KaiserPermanente WA and is available to all members. Participants select topics & review them with their health coach. At 3 months, participants have a measurement visit. The program ends at 6 months where participants will wear an activPAL and have a measurement visit. After that, there is no contact with the study team until 12 months when they will again wear an activPAL & have a final measurement visit. UPDATE: As of 3/31/2022, our final year (year 5) of the study, participants randomized to the control arm will no longer be followed to the 12-month timepoint and will end all activities after the 6-month timepoint. Healthy Living control: In this arm, participants will have phone coaching sessions focused on a variety of topics aimed at improving healthy habits. There is no focus on standing more or sitting less. |
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| Primary | Change in SystolicBlood Pressure at 6 Months | Another primary outcome is change in systolic blood pressure. This will be measured at the measurement visits using blood pressure monitors mailed to the participant | Number of participants who had a 6-month measure for SBP | Posted | Mean | 95% Confidence Interval | mmHg | Change from Baseline at 6 months |
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| Primary | Change in Diastolic Blood Pressure at 6 Months | Another primary outcome is change in diastolic blood pressure | Number of participants who had a 6-month measure for Diastolic BP | Posted | Mean | 95% Confidence Interval | mmHg | Change from Baseline at 6 months |
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| Secondary | Change in Weight at 6 Months | Participants provide their weight at each measurement visit. Weight is measured in pounds using a scale mailed to the participant. | Posted | Mean | 95% Confidence Interval | pounds | Change from Baseline at 6 months |
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| Secondary | Change in BMI at 6 Months | BMI was calculated as [weight in kg]/[height in m]2. | Posted | Mean | 95% Confidence Interval | kg/m^2 | Change from Baseline at 6 months |
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| Secondary | Change in Waist Circumference at 6 Months | Participants provided their waist circumference at each measurement visit. Waist circumference was measured at the superior border of the iliac crest. | Posted | Mean | 95% Confidence Interval | inches | Change from Baseline at 6 months |
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|
| 0 |
| 140 |
| 6 |
| 140 |
| 72 |
| 140 |
| EG001 | Healthy Living Control | In this arm, participants have a phone-based Baseline visit followed by the 1st phone-based Coaching visit. No prompting devices/desks are offered; coaching focuses on topics related to healthy living, but with no focus on sitting less/standing more. They have 10 phone calls with a health coach. Participants receive a workbook. All content is from KaiserPermanente WA and is available to all members. Participants select topics & review them with their health coach. At 3 months, participants have a measurement visit. The program ends at 6 months where participants will wear an activPAL and have a measurement visit. After that, there is no contact with the study team until 12 months when they will again wear an activPAL & have a final measurement visit. UPDATE: As of 3/31/2022, our final year (year 5) of the study, participants randomized to the control arm will no longer be followed to the 12-month timepoint and will end all activities after the 6-month timepoint. Healthy Living control: In this arm, participants will have phone coaching sessions focused on a variety of topics aimed at improving healthy habits. There is no focus on standing more or sitting less. | 0 | 143 | 6 | 143 | 47 | 143 |
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| Unrelated SAE | Cardiac disorders | Systematic Assessment | Unrelated to study |
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| Unrelated SAE | Eye disorders | Systematic Assessment | Unrelated to Study |
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| Unrelated SAE | Gastrointestinal disorders | Systematic Assessment | Unrelated to Study |
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| Unrelated SAE | General disorders | Systematic Assessment | Unrelated to Study |
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| Unrelated SAE | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated to Study |
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| Unrelated SAE | Renal and urinary disorders | Systematic Assessment | Unrelated to Study |
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| Unrelated SAE | Surgical and medical procedures | Systematic Assessment | Unrelated to Study |
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| Unrelated SAE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated to Study |
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| Unrelated Other AE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Anticipated Related AE | Skin and subcutaneous tissue disorders | Systematic Assessment | These are expected and related to wearing the device adhered to the skin with Tegaderm (potential skin irritant) |
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| Unrelated Other AE | Vascular disorders | Systematic Assessment |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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