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

University of Pennsylvania

Status: Active, not recruiting

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Tiempo Juntos Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05030948

844561

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

Details and patient eligibility

About

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].

Enrollment: 236 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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236 participants in 2 patient groups

Tiempo Juntos Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Tiempo Juntos Intervention

Attention Control

No Intervention group

Description:

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.