NCT05030948

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

August 27, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

July 30, 2021

Last Update Submit

April 27, 2026

Conditions

Mild Cognitive Impairment

Keywords

Older LatinosCardiovascular HealthSleep QualityCognitive FunctionCommunity Health WorkerWalkingPhysical Activity

Outcome Measures

Primary Outcomes (9)

  • 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)

    24 weeks

  • Change from Baseline Physical Activity Duration at 12 months

    Total time spent in activity (hours and minutes)

    48 weeks

Study Arms (2)

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.

Behavioral: Tiempo Juntos Intervention

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.

Interventions

Tiempo Juntos InterventionBEHAVIORAL

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.

Tiempo Juntos Intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Can provide informed consent
  • + 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania School of Nursing

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (129)

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MeSH Terms

Conditions

Cognitive DysfunctionSleep Initiation and Maintenance DisordersMotor Activity

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesBehavior

Study Officials

  • Gloria A Perez, PhD, CRNP

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 30, 2021

First Posted

September 1, 2021

Study Start

August 27, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)