Clinical trial NCT05030948: A Physical Activity Intervention to Promote Cognitive Health, Cardiovascular Health and Sleep in Older Latinos
Official title: A Physical Activity Intervention to Promote Cognitive Health, Cardiovascular Health and Sleep in Older Latinos
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Older Latinos
Cardiovascular Health
Sleep Quality
Cognitive Function
Community Health Worker
Walking
Physical Activity
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-09-01
Enrollment: 236
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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) \[Montreal Cognitive Assessment (MoCA) score 23 to 26 for Latino populations\].


Eligibility criteria: Inclusion Criteria:

* Can provide informed consent
* 55+ years
* Self-identify as Hispanic/Latino
* Spanish as primary language
* Willing to attend intervention / education sessions
* Access to phone/cell
* less than 150 min of activity / week (sedentary)
* Montreal Cognitive Assessment (MoCA) score (score ≥ 23 to 26 for Latino populations)

Exclusion Criteria:

* Cannot provide informed consent
* Mobility disability
* Musculoskeletal problem / co-morbidity (prevents moderate PA)

Primary outcomes:
measure: Change from Baseline Physical Activity Frequency at 3 months
timeFrame: 12 weeks
measure: Change from Baseline Physical Activity Frequency at 6 months
timeFrame: 24 weeks
measure: Change from Baseline Physical Activity Frequency at 12 months
timeFrame: 48 weeks
measure: Change from Baseline Physical Activity Intensity at 3 months
timeFrame: 12 weeks
measure: Change from Baseline Physical Activity Intensity at 6 months
timeFrame: 24 weeks
measure: Change from Baseline Physical Activity Intensity at 12 months
timeFrame: 48 weeks
measure: Change from Baseline Physical Activity Duration at 3 months
timeFrame: 12 weeks
measure: Change from Baseline Physical Activity Duration at 6 months
timeFrame: 24 weeks
measure: Change from Baseline Physical Activity Duration at 12 months
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Nursing
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Gloria A Perez, PhD, CRNP
role: PRINCIPAL_INVESTIGATOR
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