A Physical Activity Program to Disrupt Sedentary Time in Older Latinos

NCT04507464 | Completed Results DMC

• 2 other identifiers: 2020-07392P30AG022849-16
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Behavior; Cognitive Impairment

Keywords

Sedentary Behavior; Physical Activity; Cognitive Health; Older Adults; Latinos

Outcome Measures

Primary Outcomes (2)

• Number of Sedentary Bouts

  Change in number of bouts of sedentary activity at 6 weeks from baseline. One sedentary bout is defined as a 10 minute bout or longer where the activity count is less than 99 counts per minute. Sedentary Bout Parameters Minimum Length: 10 Minutes Minimum Count Value: 0 Counts Per Minute Maximum Count Value: 99 Counts Per Minute

  Baseline, 6 weeks

• Time in Sedentary Bouts

  Change from baseline to 6 weeks in minutes spent in sedentary bouts

  Baseline, 6 weeks

Secondary Outcomes (14)

• Trail Making Test A

  Baseline, 6 weeks

• Trail Making Test B

  baseline, 6 weeks

• Picture Vocabulary Test

  Baseline, 6 weeks

• List Sorting

  Baseline, 6 weeks

• Picture Sequence

  Baseline, 6 weeks

Study Arms (2)

Ecological Momentary Intervention

EXPERIMENTAL

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

Behavioral: Ecological Momentary Intervention

Physical Activity Guidelines

NO INTERVENTION

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

Interventions

Ecological Momentary Intervention 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.

Also known as: Illumivu mEMA

Ecological Momentary Intervention

Eligibility Criteria

• Age: 55 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

Location

Related Publications (1)

• 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.

  PMID: 39235836 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Ulf Bronas
• Organization: University of Illinois at Chicago

bronas@uic.edu

3123555886

Study Officials

• Ulf G Bronas, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a pilot randomized, controlled trial of a 6-week intervention for feasibility. Outcome measures will be obtained at baseline and at 6-weeks. Behavior choices and preference data will be continuously captured during the intervention. We will randomize 80 older Latinos from the Chicago Latino community to either an ecological momentary intervention using fitbits (n=40) or to physical activity guidelines (n=40).

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 11, 2020
• Study Start: November 2, 2020
• Primary Completion: April 2, 2022
• Study Completion: April 2, 2022
• Last Updated: July 25, 2023
• Results First Posted: July 25, 2023

Record last verified: 2023-06

Locations

US (1)