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A Physical Activity Intervention to Promote Cognitive Health, Cardiovascular Health and Sleep in Older Latinos

A Physical Activity Intervention to Promote Cognitive Health, Cardiovascular Health and Sleep in Older Latinos

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05030948
Enrollment
234
Registered
2021-09-01
Start date
2021-08-27
Completion date
2025-12-31
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

Older Latinos, Cardiovascular Health, Sleep Quality, Cognitive Function, Community Health Worker, Walking, Physical Activity

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

Interventions

BEHAVIORALTiempo Juntos Intervention

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.

Sponsors

University of Pennsylvania
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Physical Activity Frequency at 3 months12 weeksNumber of activity sessions
Change from Baseline Physical Activity Frequency at 6 months24 weeksNumber of activity sessions
Change from Baseline Physical Activity Frequency at 12 months48 weeksNumber of activity sessions
Change from Baseline Physical Activity Intensity at 3 months12 weeksLight, moderate, or vigorous (determined by counts per minute)
Change from Baseline Physical Activity Intensity at 6 months24 weeksLight, moderate, or vigorous (determined by counts per minute)
Change from Baseline Physical Activity Intensity at 12 months48 weeksLight, moderate, or vigorous (determined by counts per minute)
Change from Baseline Physical Activity Duration at 3 months12 weeksTotal time spent in activity (hours and minutes)
Change from Baseline Physical Activity Duration at 6 months24 weeksTotal time spent in activity (hours and minutes)
Change from Baseline Physical Activity Duration at 12 months48 weeksTotal time spent in activity (hours and minutes)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORGloria A Perez, PhD, CRNP

University of Pennsylvania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026