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

Study Overview
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Brief Summary
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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].

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

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Tiempo Juntos Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tiempo Juntos Intervention<br>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<br>* 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.<br>|
| No Intervention: Attention Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older Latinos, Cardiovascular Health, Sleep Quality, Cognitive Function, Community Health Worker, Walking, Physical Activity