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

Not Applicable

Active, not recruiting

• Conditions: Mild Cognitive Impairment
• Interventions: Behavioral: Tiempo Juntos Intervention

• Registration Number: NCT05030948
• Lead Sponsor: University of Pennsylvania

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-07-30
• Study First Submitted QC: 2021-08-26
• Study Start: 2021-08-27
• Study First Posted: 2021-09-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 236

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tiempo Juntos Intervention	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Pennsylvania School of Nursing; 🇺🇸 Philadelphia, Pennsylvania, United States