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

University of Pennsylvania2 sites in 1 country234 target enrollmentAugust 27, 2021

ConditionsMild Cognitive Impairment

InterventionsTiempo Juntos Intervention

Overview

Phase: Not Applicable
Intervention: Tiempo Juntos Intervention
Conditions: Mild Cognitive Impairment
Sponsor: University of Pennsylvania
Enrollment: 234
Locations: 2
Primary Endpoint: Change from Baseline Physical Activity Frequency at 12 months
Status: Completed
Last Updated: yesterday

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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].

Registry

clinicaltrials.gov

Start Date

August 27, 2021

End Date

December 31, 2025

Last Updated

yesterday

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Pennsylvania

Responsible Party

Principal Investigator

Gloria Adriana Perez

Principal Investigator

University of Pennsylvania

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)

Arms & Interventions

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.

Intervention: Tiempo Juntos 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.