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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05030948
Other study ID # 844561
Secondary ID 1R01AG070351-01
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 27, 2021
Est. completion date December 31, 2024

Study information

Verified date February 2024
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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].


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 236
Est. completion date December 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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. 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.

Locations

Country Name City State
United States University of Pennsylvania School of Nursing Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (129)

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* Note: There are 129 references in allClick here to view all references

Outcome

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