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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG048785 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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In this six-week behavioral intervention, sedentary older adults will receive daily health messaging via their smart phone to better understand their daily activities and emotions. Participants undergo structural and functional brain imaging before and after the intervention along with measures of their behavioral, emotional and thinking functions.
This project will obtain data on the effects of a six week intervention designed to increase subjects' motivation to increase their physical activity. Subjects will be randomized into two different conditions to examine the efficacy of self-affirmation + positive messaging versus a control group that receives negative messaging only on changes in physical activity.
We will also examine whether any differential physical activity or structured exercise engendered in the two groups is maintained at 3 months post-intervention.
Secondary outcome measures will include a battery of cognitive, psychosocial, and neuroimaging measures that are designed to explicate the mechanisms that underlie motivation effects for physical activity in sedentary older adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Brain MRI and Motivational Behavioral Intervention |
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| Active control | Active Comparator | Brain MRI and Control Behavioral Intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational MRI and Behavioral Intervention | Behavioral | Motivational messaging delivered during a functional brain MRI scan and with daily messaging |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Sedentary Behavior (Average Hour/Day) | This metric quantifies the change in the average amount of time spent sedentary each day in hours, from the baseline period to the 6-week follow-up period. It is a marker of time spent inactive. | Baseline; 6-week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Moderate-to-Vigorous Physical Activity | This measure focuses on the change in average moderate-to-vigorous physical activity (MVPA) daily minutes after the intervention compared to the pre-intervention average MVPA baseline. | Baseline; 6-week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeastern University | Boston | Massachusetts | 02120 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33945886 | Background | Ai M, Morris TP, Ordway C, Quinonez E, D'Agostino F, Whitfield-Gabrieli S, Hillman CH, Pindus DM, McAuley E, Mayo N, de la Colina AN, Phillips S, Kramer AF, Geddes M. The Daily Activity Study of Health (DASH): A pilot randomized controlled trial to enhance physical activity in sedentary older adults. Contemp Clin Trials. 2021 Jul;106:106405. doi: 10.1016/j.cct.2021.106405. Epub 2021 May 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Brain MRI and Motivational Behavioral Intervention Behavioral Intervention: Motivational messaging (self affirmation on highest ranked value and positively framed messages) delivered as daily messages, and due to the pandemic, a functional brain MRI scan at baseline was optional |
| FG001 | Active Control | Brain MRI and Control Behavioral Intervention Control Behavioral Intervention: Control motivational messaging (self affirmation on lowest ranked value and negatively framed messages) delivered as daily messages, and due to the pandemic, a functional brain MRI scan at baseline was optional |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Brain MRI and Motivational Behavioral Intervention Behavioral Intervention: Motivational messaging (self affirmation on highest ranked value and positively framed messages) delivered as daily messages, and due to the pandemic, a functional brain MRI scan at baseline was optional |
| BG001 |
| 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, 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 Sedentary Behavior (Average Hour/Day) | This metric quantifies the change in the average amount of time spent sedentary each day in hours, from the baseline period to the 6-week follow-up period. It is a marker of time spent inactive. | The number of average daily hours spent sedentary after the intervention compared to the pre-intervention baseline. | Posted | Mean | Standard Deviation | Change in average daily hours | Baseline; 6-week |
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Duration of the study (6-week intervention and baseline visit)
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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 | Intervention | Brain MRI and Motivational Behavioral Intervention Motivational MRI and Behavioral Intervention: Motivational messaging delivered during a functional brain MRI scan and with daily messaging |
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Given that the trial was conducted during lockdowns due to the COVID-19 pandemic, the original brain imaging MRI outcomes were modified. Intervention delivery was remote due to in-person data collection restrictions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meishan Ai | Northeastern University | 858-265-7288 | ai.me@northeastern.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 | Dec 17, 2019 | Feb 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 6, 2021 | Feb 27, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Control MRI and Behavioral Intervention | Behavioral | Control messaging delivered during a functional brain MRI scan and with daily messaging |
|
| Active Control |
Brain MRI and Control Behavioral Intervention Control Behavioral Intervention: Control motivational messaging (self affirmation on lowest ranked value and negatively framed messages) delivered as daily messages, and due to the pandemic, a functional brain MRI scan at baseline was optional |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| education | Mean | Standard Deviation | years |
|
| Active Control |
Brain MRI and Control Behavioral Intervention Control Behavioral Intervention: Control motivational messaging (self affirmation on lowest ranked value and negatively framed messages) delivered as daily messages, and due to the pandemic, a functional brain MRI scan at baseline was optional |
|
|
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| Secondary | Change in Moderate-to-Vigorous Physical Activity | This measure focuses on the change in average moderate-to-vigorous physical activity (MVPA) daily minutes after the intervention compared to the pre-intervention average MVPA baseline. | The change in average number of daily minutes spent in moderate-to-vigorous physical activity after the intervention compared to the pre-intervention baseline. | Posted | Mean | Standard Deviation | Change in minutes daily | Baseline; 6-week |
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| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Active Control | Brain MRI and Control Behavioral Intervention Control MRI and Behavioral Intervention: Control messaging delivered during a functional brain MRI scan and with daily messaging | 0 | 19 | 0 | 19 | 0 | 19 |
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