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

April 27, 2026 updated by: Gloria Adriana Perez, University of Pennsylvania
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].

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

234

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tiempo 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. 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.
Behavioral: Tiempo 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.
No Intervention: Attention Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Physical Activity Frequency at 3 months
Time Frame: 12 weeks
Number of activity sessions
12 weeks
Change from Baseline Physical Activity Frequency at 6 months
Time Frame: 24 weeks
Number of activity sessions
24 weeks
Change from Baseline Physical Activity Frequency at 12 months
Time Frame: 48 weeks
Number of activity sessions
48 weeks
Change from Baseline Physical Activity Intensity at 3 months
Time Frame: 12 weeks
Light, moderate, or vigorous (determined by counts per minute)
12 weeks
Change from Baseline Physical Activity Intensity at 6 months
Time Frame: 24 weeks
Light, moderate, or vigorous (determined by counts per minute)
24 weeks
Change from Baseline Physical Activity Intensity at 12 months
Time Frame: 48 weeks
Light, moderate, or vigorous (determined by counts per minute)
48 weeks
Change from Baseline Physical Activity Duration at 3 months
Time Frame: 12 weeks
Total time spent in activity (hours and minutes)
12 weeks
Change from Baseline Physical Activity Duration at 6 months
Time Frame: 24 weeks
Total time spent in activity (hours and minutes)
24 weeks
Change from Baseline Physical Activity Duration at 12 months
Time Frame: 48 weeks
Total time spent in activity (hours and minutes)
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Gloria A Perez, PhD, CRNP, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2021

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

July 30, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 844561
  • 1R01AG070351-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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