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Completed

NCT Number: NCT05030948

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

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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Key information

Conditions

Mild Cognitive Impairment Behavior Cognition Disorders Cognitive Dysfunction Dyssomnias Mental Disorders Motor Activity Nervous System Diseases Neurocognitive Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania School of Nursing

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Change from Baseline Physical Activity Frequency at 3 months

    Time frame: 12 weeks

    Number of activity sessions

  2. Change from Baseline Physical Activity Frequency at 6 months

    Time frame: 24 weeks

    Number of activity sessions

  3. Change from Baseline Physical Activity Frequency at 12 months

    Time frame: 48 weeks

    Number of activity sessions

  4. Change from Baseline Physical Activity Intensity at 3 months

    Time frame: 12 weeks

    Light, moderate, or vigorous (determined by counts per minute)

  5. Change from Baseline Physical Activity Intensity at 6 months

    Time frame: 24 weeks

    Light, moderate, or vigorous (determined by counts per minute)

  6. Change from Baseline Physical Activity Intensity at 12 months

    Time frame: 48 weeks

    Light, moderate, or vigorous (determined by counts per minute)

  7. Change from Baseline Physical Activity Duration at 3 months

    Time frame: 12 weeks

    Total time spent in activity (hours and minutes)

  8. Change from Baseline Physical Activity Duration at 6 months

    Time frame: 24 weeks

    Total time spent in activity (hours and minutes)

  9. Change from Baseline Physical Activity Duration at 12 months

    Time frame: 48 weeks

    Total time spent in activity (hours and minutes)

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2021
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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