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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG070351-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This study is a randomized, single-blind, controlled trial that will test a multilevel intervention, Tiempo Juntos para la Salud, (Time Together for Health) designed to promote moderate-intensity physical activity; theoretically grounded mediators; and secondary outcomes of cardiovascular health, sleep and cognitive function. Participants will have 4 visits over a year long period. Data collection will occur at baseline, 3 months, 6 months, and 12 months among 216 Spanish language-dominant Latinos aged 55 and older with Mild Cognitive Impairment (MCI) [Montreal Cognitive Assessment (MoCA) score 23 to 26 for Latino populations].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiempo Juntos Intervention | Experimental | If assigned to this group, participants will take part in weekly 1-hour group sessions twice a week for 3 months. The sessions will be with a trained Community Health Worker that will involve group (5-6 participants) moderate-intensity walking. They will take place at community partner sites during times when all participants can attend. In case of adverse weather, indoor locations are available through community partners. Walks will reflect participant goals and abilities, initially lasting 10 minutes, with 5-minute stretching "warm-up" and 5-minute "cool down" exercises, for a total of 20 minutes. Walk duration will increase by 5 minutes/week to at least 30 minutes with program content delivery time decreasing to accommodate increased walk times within the 1-hour session. Upon completing the 3 months of physical activity sessions, for the next 3 months, they will receive motivational "booster" sessions delivered every other week via phone calls/text messaging. |
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| Attention Control | No Intervention | If assigned to this group, participants will take part in 1-hour group (5-6 participants) sessions delivered twice a week for 3 months. The sessions will be with a trained Community Health Worker or qualified staff that will involve reviewing education topics in Spanish related to adult health. They will take place at community partner sites or remotely during times when all participants can attend. In case of adverse weather, indoor locations, or remote options will be available. Upon completing the 3 months of education sessions, for the next 3 months, they will receive educational "booster" sessions delivered every other week via phone calls/text messaging. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiempo Juntos Intervention | Behavioral | If assigned to this group, participants will take part in weekly 1-hour group sessions twice a week for 3 months. The sessions will be with a trained Community Health Worker that will involve group (5-6 participants) moderate-intensity walking. Upon completing the 3 months of physical activity sessions, for the next 3 months, they will receive motivational "booster" sessions delivered every other week via phone calls/text messaging. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Physical Activity Frequency at 3 months | Number of activity sessions | 12 weeks |
| Change from Baseline Physical Activity Frequency at 6 months | Number of activity sessions | 24 weeks |
| Change from Baseline Physical Activity Frequency at 12 months | Number of activity sessions | 48 weeks |
| Change from Baseline Physical Activity Intensity at 3 months | Light, moderate, or vigorous (determined by counts per minute) | 12 weeks |
| Change from Baseline Physical Activity Intensity at 6 months | Light, moderate, or vigorous (determined by counts per minute) | 24 weeks |
| Change from Baseline Physical Activity Intensity at 12 months | Light, moderate, or vigorous (determined by counts per minute) | 48 weeks |
| Change from Baseline Physical Activity Duration at 3 months | Total time spent in activity (hours and minutes) | 12 weeks |
| Change from Baseline Physical Activity Duration at 6 months | Total time spent in activity (hours and minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gloria A Perez, PhD, CRNP | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania School of Nursing | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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|
| 24 weeks |
| Change from Baseline Physical Activity Duration at 12 months | Total time spent in activity (hours and minutes) | 48 weeks |
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| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001519 | Behavior |