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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG054916 | U.S. NIH Grant/Contract | View source | |
| A176000 | Other Identifier | UW, Madison | |
| EDUC/KINESIOLOGY/KINESIO | Other Identifier | UW, Madison |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of the expanded study is to examine the effectiveness of a "Stand Up and Move More" intervention to reduce sedentary behavior in older adults from underserved communities.
Based on successful pilot research in Rock County, WI, and the receipt of funding from the National Institutes of Health, the investigators expanded research to additional counties in Wisconsin for a total of four counties (i.e., Dane, Iowa, Rock, and Vilas counties). Sample size will increase and participants will be randomly assigned to the intervention group (Stand Up and Move More group) or a wait-list control group (who receive the intervention after 12 weeks). The Stand Up and Move More intervention/workshop involves sessions once/week for four weeks with a refresher session at 8 weeks. Assessments will be conducted before the intervention/workshop begins, and then again at 4 weeks and 12 weeks. We have added several questionnaires to examine potential mediators of behavior change (e.g., self-efficacy, self-regulation, outcome expectancies).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stand up intervention | Experimental | four week behavioral intervention based on self-regulation theory which is designed to facilitate the development of action plans to break up prolonged sitting |
|
| Control | No Intervention | No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stand up and move more | Behavioral | 4 week behavioral intervention involving the development and implementation of action plans |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Sedentary Time Per Day | Participants wore monitors during the day to assess total sitting time/day | Baseline, 4 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Short Physical Performance Battery (SPPB) Score | The SPPB is an assessment of physical limitations. It combines scores from a balance test, gait speed test, and a chair stand test. The total possible range of scores is 1-12, higher scores indicate better function/less functional limitations. | Baseline, 4 weeks, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelli Koltyn, PhD | UW-Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kelli Koltyn | Madison | Wisconsin | 53706 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stand up Intervention | four week behavioral intervention based on self-regulation theory which is designed to facilitate the development of action plans to break up prolonged sitting Stand up and move more: 4 week behavioral intervention involving the development and implementation of action plans |
| FG001 | Control | No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stand up Intervention | four week behavioral intervention based on self-regulation theory which is designed to facilitate the development of action plans to break up prolonged sitting Stand up and move more: 4 week behavioral intervention involving the development and implementation of action plans |
| BG001 |
| 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 | Total Sedentary Time Per Day | Participants wore monitors during the day to assess total sitting time/day | The number of participants analyzed differs for each time point due to participant availability, attrition, and not all participants wore the monitors per protocol for each visit (10 hours/day for a full week each time point). | Posted | Mean | Standard Deviation | minute/day | Baseline, 4 weeks, 12 weeks |
|
up to 12 weeks
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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 | Stand up Intervention | four week behavioral intervention based on self-regulation theory which is designed to facilitate the development of action plans to break up prolonged sitting Stand up and move more: 4 week behavioral intervention involving the development and implementation of action plans |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kelli F Koltyn | University of Wisconsin - Madison | 608-263-6746 | kelli.koltyn@wisc.edu |
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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 | Feb 21, 2018 | Feb 21, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Lost to Follow-up |
|
| Control |
No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group |
|
|
| Secondary | Short Physical Performance Battery (SPPB) Score | The SPPB is an assessment of physical limitations. It combines scores from a balance test, gait speed test, and a chair stand test. The total possible range of scores is 1-12, higher scores indicate better function/less functional limitations. | The number of participants analyzed differs for each time point due to participant availability and attrition. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks, 12 weeks |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Control | No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group | 0 | 36 | 0 | 36 | 0 | 36 |
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| 4 weeks |
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| 12 weeks |
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