A Physical Activity Program to Disrupt Sedentary Time in Older Latinos (PAIS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04507464|
Recruitment Status : Completed
First Posted : August 11, 2020
Last Update Posted : June 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Sedentary Behavior Cognitive Impairment||Behavioral: Ecological Momentary Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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).|
|Masking:||None (Open Label)|
|Official Title:||A Physical Activity Program to Disrupt Sedentary Time in Older Latinos|
|Actual Study Start Date :||November 2, 2020|
|Actual Primary Completion Date :||April 2, 2022|
|Actual Study Completion Date :||April 2, 2022|
Experimental: Ecological Momentary Intervention
Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.
Behavioral: 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.
Other Name: Illumivu mEMA
No Intervention: Physical Activity Guidelines
Participants will be sent general guidelines for disruption of sedentary time.
- Sedentary Time [ Time Frame: Baseline to end of 6 weeks ]Change in sedentary time from baseline to 6 weeks follow up
- Cognitive Function [ Time Frame: Baseline to end of 6 weeks ]Change in cognitive function measures assessed through the NIH Toolbox from baseline to 6 weeks
- Feasibility and Acceptability [ Time Frame: End of 6 weeks ]Formative assessments of usage of the smartphone app and participants' behavioral choices
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04507464
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60608|
|Principal Investigator:||Ulf G Bronas, PhD||University of Illinois at Chicago|