A Physical Activity Program to Disrupt Sedentary Time in Older Latinos

NCT ID: NCT04507464

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2022-04-02

Brief Summary

To test the feasibility of an intervention designed to replace sedentary time with physical activity in older Latinos, delivered in their homes to improve cognitive function and brain connectivity.

Detailed Description

After being informed of the study and potential risks, all patients giving informed consent will undergo a focused phone interviews, followed by screening to determine eligibility. Participants that meet inclusion criteria will undergo baseline cognitive function testing via video (following NIH toolbox guidelines for remote cognitive function assessment), followed by a one week measurement of sedentary time using a physical activity monitor (actigraphy). At week 0, participants will be randomized into either a physical activity group to break up sedentary time or activity guidelines only in a 1:1 ratio. Follow up occurs at 6 weeks using the same measures as baseline.

Conditions

Sedentary Behavior; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ecological Momentary Intervention

Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.

Group Type: EXPERIMENTAL

Ecological Momentary Intervention

Intervention Type: BEHAVIORAL

Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.

Physical Activity Guidelines

Participants will be sent general guidelines for disruption of sedentary time.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ecological Momentary Intervention

Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.

Intervention Type: BEHAVIORAL

Other Intervention Names

Illumivu mEMA

Eligibility Criteria

Inclusion Criteria

• no history of major head trauma
• ownership of a smartphone
• ability to make video calls

Exclusion Criteria

• Requires assistive ambulation;
• Unstable angina,
• Claudication
• severe arthritis,
• extreme dyspnea on exertion,
• Class III-IV heart failure;
• Current uncontrolled sustained arrhythmias,
• severe/symptomatic aortic or mitral stenosis,
• hypertrophic obstructive cardiomyopathy,
• severe pulmonary hypertension,
• active myocarditis/pericarditis,
• thrombophlebitis,
• recent systemic/pulmonary embolus (within 3 months);
• Revascularization procedures within the previous 6 months;
• Pregnancy

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Ulf G. Bronas

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulf G Bronas, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

References

Bronas UG, Marquez DX, Fritschi C, Petrarca K, Kitsiou S, Ajilore O, Tintle N. Ecological Momentary Intervention to Replace Sedentary Time With Physical Activity to Improve Executive Function in Midlife and Older Latino Adults: Pilot Randomized Controlled Trial. J Med Internet Res. 2024 Sep 5;26:e55079. doi: 10.2196/55079.

Reference Type: DERIVED

PMID: 39235836 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2P30AG022849-16

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020-0739

Identifier Type: -

Identifier Source: org_study_id