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Epidemiological findings indicate that older adults do not meet physical activity (PA) guidelines & spend up to 11 hrs/day sitting. Given the high prevalence of sedentary behavior (SB), the higher chronic disease risk in this population, & the age-associated challenges of meeting traditional PA guidelines, involving longer bouts of moderate PA, the investigators hypothesize that older adult health will benefit from new strategies to interrupt sitting. This protocol "Sedentary Behavior Interrupted: A randomized trial of 3-month effects on biomarkers of healthy aging and physical functioning in the real world (Project 2)" is part of a National Institutes of Aging Program Grant called "Sedentary Time & Aging Mortality and Physical Function (STAR). The overall purpose of the STAR program to is to better understand how to interrupt sitting time and the consequences for healthy aging in postmenopausal women. This protocol (also referred to Project 2 of the STAR program) is a 3-arm randomized control trial designed to assess ways of interrupting sitting in 405 overweight, postmenopausal women.
Primary Aims:
In our primary biomarker outcomes of glucose regulation (fasting insulin & glucose, HbA1c, HOMA-IR) & blood pressure (BP):
Secondary aims
Exploratory aims
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Living Attention Control | Active Comparator | Participants in the attention control condition will receive a healthy aging educational intervention. This group will receive one in-person health coaching sessions and 6 phone counseling sessions. |
|
| Reduce Sitting | Experimental | Participants in the Reduce Sitting condition will receive an intervention aimed at reducing daily sitting time. This group will receive five in-person health coaching sessions and two phone counseling sessions. |
|
| Sit-to-Stand Transition | Experimental | Participants in the Sit-to-Stand Transition condition will receive an intervention aimed at increasing the daily number of brief sit-to-stand transitions. This group will receive five in-person health coaching sessions and two phone counseling sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Coaching | Behavioral | Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, & relapse prevention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Regulation (mU/L) | Mean Insulin (mU/L) collected via fasting blood draw at Baseline and 3-Months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported Physical Functioning | Self-reported physical functioning was assessed using the Rand SF 36-Item Health Survey that assesses 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The range of scores is 0 - 100 with higher scores meaning better physical functioning. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40709462 | Derived | Hartman SJ, LaCroix AZ, Sears DD, Natarajan L, Zablocki RW, Chen R, Patterson JS, Dillon L, Sallis JF, Schenk S, Dunstan DW, Owen N, Rosenberg DE. Impacts of Reducing Sitting Time or Increasing Sit-to-Stand Transitions on Blood Pressure and Glucose Regulation in Postmenopausal Women: Three-Arm Randomized Controlled Trial. Circulation. 2025 Aug 26;152(8):492-504. doi: 10.1161/CIRCULATIONAHA.124.073385. Epub 2025 Jul 25. | |
| 38671485 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Health Living Attention Control | Participants in the attention control condition will receive a healthy aging educational intervention. This group will receive one in-person health coaching sessions and 6 phone counseling sessions. Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, & relapse prevention. |
| FG001 | Reduce Sitting | Participants in the Reduce Sitting condition will receive an intervention aimed at reducing daily sitting time. This group will receive five in-person health coaching sessions and two phone counseling sessions. Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, & relapse prevention. activPAL inclinometer: Participants in the intervention study arms (B & C) will wear the ActivPAL device for the first 4 weeks of the program and then again in weeks 8 and 9. The device will monitor their sitting and standing time and will allow Health Coaches to provide feedback and will assist the participant in developing an action plan. Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.: Participants in the intervention study arms (B & C) will receive tools to prompt standing or sit-to-stand transitions such as wearable wrist devices, standing desks or tables (Group B only), mechanical and/or electronic timers, or access to mobile apps or computer programs. |
| FG002 | Sit-to-Stand Transition | Participants in the Sit-to-Stand Transition condition will receive an intervention aimed at increasing the daily number of brief sit-to-stand transitions. This group will receive five in-person health coaching sessions and two phone counseling sessions. Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, & relapse prevention. activPAL inclinometer: Participants in the intervention study arms (B & C) will wear the ActivPAL device for the first 4 weeks of the program and then again in weeks 8 and 9. The device will monitor their sitting and standing time and will allow Health Coaches to provide feedback and will assist the participant in developing an action plan. Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.: Participants in the intervention study arms (B & C) will receive tools to prompt standing or sit-to-stand transitions such as wearable wrist devices, standing desks or tables (Group B only), mechanical and/or electronic timers, or access to mobile apps or computer programs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Health Living Attention Control | Participants in the attention control condition will receive a healthy aging educational intervention. This group will receive one in-person health coaching sessions and 6 phone counseling sessions. Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, & relapse prevention. |
| 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 | Insulin Regulation (mU/L) | Mean Insulin (mU/L) collected via fasting blood draw at Baseline and 3-Months | Posted | Mean | 95% Confidence Interval | mU/L | 3 months |
|
Adverse event data were collected while the participants were active in the study for 3-months.
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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 | Health Living Attention Control | Participants in the attention control condition will receive a healthy aging educational intervention. This group will receive one in-person health coaching sessions and 6 phone counseling sessions. Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, & relapse prevention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Irritation | Skin and subcutaneous tissue disorders | MEDRA | Non-systematic Assessment | Skin Irritation from wearing the study devices |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sheri Hartman | UC San Diego | (858) 534-9235 | sjhartman@health.ucsd.edu |
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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 | May 1, 2021 | Oct 7, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 26, 2025 | Sep 16, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 29, 2022 | Aug 20, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| activPAL inclinometer | Device | Participants in the intervention study arms (B & C) will wear the ActivPAL device for the first 4 weeks of the program and then again in weeks 8 and 9. The device will monitor their sitting and standing time and will allow Health Coaches to provide feedback and will assist the participant in developing an action plan. |
|
| Tools to Prompt Standing or Prompt Sit-to-Stand Transitions. | Other | Participants in the intervention study arms (B & C) will receive tools to prompt standing or sit-to-stand transitions such as wearable wrist devices, standing desks or tables (Group B only), mechanical and/or electronic timers, or access to mobile apps or computer programs. |
|
| 3 months |
| Zablocki RW, Hartman SJ, Di C, Zou J, Carlson JA, Hibbing PR, Rosenberg DE, Greenwood-Hickman MA, Dillon L, LaCroix AZ, Natarajan L. Using functional principal component analysis (FPCA) to quantify sitting patterns derived from wearable sensors. Int J Behav Nutr Phys Act. 2024 Apr 26;21(1):48. doi: 10.1186/s12966-024-01585-8. |
| 33983131 | Derived | Hartman SJ, Dillon LW, LaCroix AZ, Natarajan L, Sears DD, Owen N, Dunstan DW, Sallis JF, Schenk S, Allison M, Takemoto M, Herweck AM, Nguyen B, Rosenberg DE. Interrupting Sitting Time in Postmenopausal Women: Protocol for the Rise for Health Randomized Controlled Trial. JMIR Res Protoc. 2021 May 13;10(5):e28684. doi: 10.2196/28684. |
| BG001 | Reduce Sitting | Participants in the Reduce Sitting condition will receive an intervention aimed at reducing daily sitting time. This group will receive five in-person health coaching sessions and two phone counseling sessions. Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, & relapse prevention. activPAL inclinometer: Participants in the intervention study arms (B & C) will wear the ActivPAL device for the first 4 weeks of the program and then again in weeks 8 and 9. The device will monitor their sitting and standing time and will allow Health Coaches to provide feedback and will assist the participant in developing an action plan. Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.: Participants in the intervention study arms (B & C) will receive tools to prompt standing or sit-to-stand transitions such as wearable wrist devices, standing desks or tables (Group B only), mechanical and/or electronic timers, or access to mobile apps or computer programs. |
| BG002 | Sit-to-Stand Transition | Participants in the Sit-to-Stand Transition condition will receive an intervention aimed at increasing the daily number of brief sit-to-stand transitions. This group will receive five in-person health coaching sessions and two phone counseling sessions. Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, & relapse prevention. activPAL inclinometer: Participants in the intervention study arms (B & C) will wear the ActivPAL device for the first 4 weeks of the program and then again in weeks 8 and 9. The device will monitor their sitting and standing time and will allow Health Coaches to provide feedback and will assist the participant in developing an action plan. Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.: Participants in the intervention study arms (B & C) will receive tools to prompt standing or sit-to-stand transitions such as wearable wrist devices, standing desks or tables (Group B only), mechanical and/or electronic timers, or access to mobile apps or computer programs. |
| BG003 | 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 | Number | participants |
|
| OG002 | Sit-to-Stand Transition | Participants in the Sit-to-Stand Transition condition will receive an intervention aimed at increasing the daily number of brief sit-to-stand transitions. This group will receive five in-person health coaching sessions and two phone counseling sessions. Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, & relapse prevention. activPAL inclinometer: Participants in the intervention study arms (B & C) will wear the ActivPAL device for the first 4 weeks of the program and then again in weeks 8 and 9. The device will monitor their sitting and standing time and will allow Health Coaches to provide feedback and will assist the participant in developing an action plan. Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.: Participants in the intervention study arms (B & C) will receive tools to prompt standing or sit-to-stand transitions such as wearable wrist devices, standing desks or tables (Group B only), mechanical and/or electronic timers, or access to mobile apps or computer programs. |
|
|
| Secondary | Self-Reported Physical Functioning | Self-reported physical functioning was assessed using the Rand SF 36-Item Health Survey that assesses 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The range of scores is 0 - 100 with higher scores meaning better physical functioning. | Posted | Mean | Standard Error | score on a scale | 3 months |
|
|
|
| 0 |
| 135 |
| 0 |
| 135 |
| 8 |
| 135 |
| EG001 | Reduce Sitting | Participants in the Reduce Sitting condition will receive an intervention aimed at reducing daily sitting time. This group will receive five in-person health coaching sessions and two phone counseling sessions. Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, & relapse prevention. activPAL inclinometer: Participants in the intervention study arms (B & C) will wear the ActivPAL device for the first 4 weeks of the program and then again in weeks 8 and 9. The device will monitor their sitting and standing time and will allow Health Coaches to provide feedback and will assist the participant in developing an action plan. Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.: Participants in the intervention study arms (B & C) will receive tools to prompt standing or sit-to-stand transitions such as wearable wrist devices, standing desks or tables (Group B only), mechanical and/or electronic timers, or access to mobile apps or computer programs. | 0 | 136 | 0 | 136 | 28 | 136 |
| EG002 | Sit-to-Stand Transition | Participants in the Sit-to-Stand Transition condition will receive an intervention aimed at increasing the daily number of brief sit-to-stand transitions. This group will receive five in-person health coaching sessions and two phone counseling sessions. Health Coaching: Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, & relapse prevention. activPAL inclinometer: Participants in the intervention study arms (B & C) will wear the ActivPAL device for the first 4 weeks of the program and then again in weeks 8 and 9. The device will monitor their sitting and standing time and will allow Health Coaches to provide feedback and will assist the participant in developing an action plan. Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.: Participants in the intervention study arms (B & C) will receive tools to prompt standing or sit-to-stand transitions such as wearable wrist devices, standing desks or tables (Group B only), mechanical and/or electronic timers, or access to mobile apps or computer programs. | 0 | 136 | 0 | 136 | 26 | 136 |
|
| Pain | Musculoskeletal and connective tissue disorders | MEDRA | Non-systematic Assessment |
|
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