Back to resultsA Physical Activity Intervention to Promote Cognitive Health, Cardiovascular Health and Sleep in Older Latinos
Primary Purpose
Mild Cognitive Impairment
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tiempo Juntos Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Older Latinos, Cardiovascular Health, Sleep Quality, Cognitive Function, Community Health Worker, Walking, Physical Activity
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)
Sites / Locations
- University of Pennsylvania School of NursingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Tiempo Juntos Intervention
Attention Control
Arm 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.
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.
Outcomes
Primary Outcome Measures
Change from Baseline Physical Activity Frequency at 3 months
Number of activity sessions
Change from Baseline Physical Activity Frequency at 6 months
Number of activity sessions
Change from Baseline Physical Activity Frequency at 12 months
Number of activity sessions
Change from Baseline Physical Activity Intensity at 3 months
Light, moderate, or vigorous (determined by counts per minute)
Change from Baseline Physical Activity Intensity at 6 months
Light, moderate, or vigorous (determined by counts per minute)
Change from Baseline Physical Activity Intensity at 12 months
Light, moderate, or vigorous (determined by counts per minute)
Change from Baseline Physical Activity Duration at 3 months
Total time spent in activity (hours and minutes)
Change from Baseline Physical Activity Duration at 6 months
Total time spent in activity (hours and minutes)
Change from Baseline Physical Activity Duration at 12 months
Total time spent in activity (hours and minutes)
Secondary Outcome Measures
Full Information
NCT ID
NCT05030948
First Posted
July 30, 2021
Last Updated
November 1, 2022
Sponsor
University of Pennsylvania
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05030948
Brief Title
A Physical Activity Intervention to Promote Cognitive Health, Cardiovascular Health and Sleep in Older Latinos
Official Title
A Physical Activity Intervention to Promote Cognitive Health, Cardiovascular Health and Sleep in Older Latinos
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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].
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Older Latinos, Cardiovascular Health, Sleep Quality, Cognitive Function, Community Health Worker, Walking, Physical Activity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tiempo Juntos Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Attention Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Tiempo Juntos Intervention
Intervention 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. 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 Measure Information:
Title
Change from Baseline Physical Activity Frequency at 3 months
Description
Number of activity sessions
Time Frame
12 weeks
Title
Change from Baseline Physical Activity Frequency at 6 months
Description
Number of activity sessions
Time Frame
24 weeks
Title
Change from Baseline Physical Activity Frequency at 12 months
Description
Number of activity sessions
Time Frame
48 weeks
Title
Change from Baseline Physical Activity Intensity at 3 months
Description
Light, moderate, or vigorous (determined by counts per minute)
Time Frame
12 weeks
Title
Change from Baseline Physical Activity Intensity at 6 months
Description
Light, moderate, or vigorous (determined by counts per minute)
Time Frame
24 weeks
Title
Change from Baseline Physical Activity Intensity at 12 months
Description
Light, moderate, or vigorous (determined by counts per minute)
Time Frame
48 weeks
Title
Change from Baseline Physical Activity Duration at 3 months
Description
Total time spent in activity (hours and minutes)
Time Frame
12 weeks
Title
Change from Baseline Physical Activity Duration at 6 months
Description
Total time spent in activity (hours and minutes)
Time Frame
24 weeks
Title
Change from Baseline Physical Activity Duration at 12 months
Description
Total time spent in activity (hours and minutes)
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gloria A Perez, PhD, CRNP
Phone
215-746-1840
Email
adrianag@nursing.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gloria A Perez, PhD, CRNP
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania School of Nursing
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gloria A Perez, PhD, CRNP
Phone
215-746-1840
Email
adrianag@nursing.upenn.edu
First Name & Middle Initial & Last Name & Degree
Gloria A Perez, PhD, CRNP
First Name & Middle Initial & Last Name & Degree
Nancy A Hodgson, PhD, RN
First Name & Middle Initial & Last Name & Degree
Antonia Villarruel, PhD, RN
First Name & Middle Initial & Last Name & Degree
Nalaka S. Gooneratne, MD, MSc
First Name & Middle Initial & Last Name & Degree
Subhash Aryal, PhD
First Name & Middle Initial & Last Name & Degree
Norma B Coe, PhD
First Name & Middle Initial & Last Name & Degree
David X Marquez, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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A Physical Activity Intervention to Promote Cognitive Health, Cardiovascular Health and Sleep in Older Latinos
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