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This protocol "Sedentary Behavior Interrupted: A randomized crossover trial of acute effects on biomarkers of healthy aging in the laboratory (Project 1)" 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 1 of the STAR program) is a 3-condition randomized crossover clinical trial of up to 86 postmenopausal women to test whether different interruptions to prolonged sitting improve metabolism.
The specific aims of this protocol include:
Aim 1. To investigate the acute effect of sitting interruption modalities on postprandial glucose and insulin concentrations, compared to prolonged sitting.
Aim 2. To investigate the acute effect of sitting interruption modalities on the physiologic parameters of endothelial function, compared to prolong sitting.
Aim 3. To explore the moderating effect of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Condition (Protocol A) | No Intervention | Following a one-hour sitting run-in period, participants will sit for a 5-hour period including a mid-point bathroom break. | |
| Frequent Sit-to-Stands (Protocol B) | Experimental | Following a 1-hour sitting run-in period, participants will sit for a 5-hour period including a 2-min stand every 15 min throughout the 5-hr protocol period and a mid-point bathroom break. |
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| Stand More (Protocol C) | Experimental | Following a 1-hour sitting run-in period, participants will sit for a 5-hour period including 5 8-minute standing breaks, 1 per hour, and a mid-point bathroom break. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frequent sit-to-stands | Behavioral | Participants will visit the clinic for a 6-hour monitoring period. Following a 1-hour sitting run-in period, participants will sit for an additional 5-hour period including a 2-min stand every 15 min throughout the 5-hr protocol period. Baseline, mid-point, and end-of-visit bathroom breaks for urine sample collection will be conducted, with additional bathroom breaks allowed as needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial glucose | To investigate the acute effect of sitting interruption modalities on postprandial glucose compared to prolonged sitting. | 5 hours |
| Insulin | To investigate the acute effect of sitting interruption modalities on insulin concentrations compared to prolonged sitting. | 5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Flow mediated dilation | To investigate the acute effect of sitting interruption modalities on flow mediated dilation compared to prolonged sitting | 5 hours |
| Blood pressure | To investigate the acute effect of sitting interruption modalities on blood pressure compared to prolonged sitting. |
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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 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2022 | Apr 17, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Stand More | Behavioral | Participants will visit the clinic for a 6-hour monitoring period. Following a 1-hour sitting run-in period, participants will sit for an additional 5-hour period including 5 8-minute standing interruptions, 1 per hour. Baseline, mid-point, and end-of-visit bathroom breaks for urine sample collection will be conducted, with additional bathroom breaks allowed as needed. |
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| 5 hours |