Sedentary BehaviorPAISNCT04507464
A Physical Activity Program to Disrupt Sedentary Time in Older Latinos
A study testing Ecological Momentary Intervention in people with Sedentary Behavior and Cognitive Impairment, run by University of Illinois at Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Cognitive Impairment
- What is being tested?
- Ecological Momentary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 2 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no history of major head trauma
- ownership of a smartphone
- ability to make video calls
Who cannot join
- Requires assistive ambulation;
- Unstable angina,
- Claudication
- severe arthritis,
- extreme dyspnea on exertion,
- Class III-IV heart failure;
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60608
About this study
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.
Read the 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
- Being tested
- Ecological Momentary Intervention
- Keywords
- Sedentary Behavior, Physical Activity, Cognitive Health, Older Adults, Latinos
- Medical subject headings
- Sedentary Behavior, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological Momentary InterventionBehavioural
Also called Illumivu mEMA
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.
| Study group | Role | What they receive |
|---|---|---|
| Ecological Momentary Intervention | Experimental | Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application. Receives: Behavioral: Ecological Momentary Intervention |
| Physical Activity Guidelines | No intervention | Participants will be sent general guidelines for disruption of sedentary time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6 weeks
Time in Sedentary Bouts
Change from baseline to 6 weeks in minutes spent in sedentary bouts
Measured: Baseline, 6 weeks
Secondary outcomes (14)
Trail Making Test A
Measure of pschycomotor speed. Subjects connect a series of encircled numbers in numerical order. The score is the time in seconds it takes the subject to complete the test. A lower score/time is better. Outcome is change in time to completion of TMT-A in seconds from baseline to 6 weeks.
Measured: Baseline, 6 weeks
Trail Making Test B
Measure of executive function. Subjects connect encircled numbers and letters in numerical and alphabetical order, alternating between the numbers and letters. Score is the time in seconds it takes the subject to complete the test. A lower score/time is better. Outcome is change from baseline to 6 weeks in seconds. Lower time is better.
Measured: baseline, 6 weeks
Picture Vocabulary Test
A measure of general vocabulary knowledge and is considered to be a strong measure of crystallized abilities (those abilities that are more dependent upon past learning experiences and are relatively consistent across the adult life span). The respondent is presented with an audio recording of a word and four photographic images on the iPad screen, and is asked to select the picture that most closely matches the meaning of the word. This is repeated over 4 minutes. A theta score is very similar to a z-score, which is a statistic with a mean of zero and a standard deviation of one. A higher score is better
Measured: Baseline, 6 weeks
List Sorting
The List Sorting test requires immediate recall and sequencing of different visually and orally presented stimuli (i.e., "working memory"). Pictures of different foods and animals are displayed with accompanying audio recording and written text (e.g., "elephant"), and the participant is asked to say the items back in size order from smallest to largest, first within a single dimension (either animals or foods, called 1-List) and then on two dimensions (foods, then animals, called 2-List). List Sorting is scored by summing the total number of items correctly recalled and sequenced on 1-List and 2-List, which can range from 0-26. Higher scores indicate higher levels of working memory. Change from baseline to post-test follow-up at 6-weeks is reported.
Measured: Baseline, 6 weeks
Picture Sequence
A measure developed for the assessment of episodic memory. Participants are asked to recall the sequence of pictures demonstrated over two learning trials; sequence length varies from 6-18 pictures. Participants are given credit for each adjacent pair of pictures they correctly placed. The number of adjacent pairs placed correctly for each of trials 1 and 2 is converted to a theta score and a standard score is generated. Change from baseline to 6 weeks is reported. This provides a gauge of improvement or decline from one assessment to another, irrespective of demographic factors. A change in a participant's Uncorrected Standard score (or theta score) from Time 1 to Time 2 represents an absolute change in the level of performance for that individual since the previous assessment. Higher score is better.
Measured: Baseline, 6 weeks
Oral Reading Recognition Test
Participant is asked to read and pronounce letters and words as accurately as possible. Administrator scores them as right or wrong (number correct words is used). This test is a measure of reading decoding skill. The Reading Test is a measure of reading decoding skill and, like vocabulary, is considered among the crystallized abilities; those abilities are generally more dependent upon past learning experiences and consistent across the adult life span. Change in Reading Uncorrected score is reported and is useful in evaluating pure change in performance from one assessment to another. Higher change in Uncorrected score for Reading would mean that the participant is able to correctly identify more difficult words on the subsequent assessment, which may indicate developmental growth or a return to a previous higher level of functioning.Change from baseline to 6 weeks is reported. A higher score is better.
Measured: Baseline, 6 weeks
Crystalized Cognition
This composite includes the Picture Vocabulary and Reading Tests and represent an accumulated store of verbal knowledge and skills. The composite score is derived by averaging the standard scores of each of these measures, and then deriving standard scores based on this new distribution. Uncorrected standard score is generated and reported. Crystallized Cognition Composite score is considered a global assessment of individual verbal cognition. Crystallized abilities are presumed to be more dependent on experience and less on biological influences. They represent an accumulated store of verbal knowledge and skills. Higher scores indicate higher levels of functioning. Change in uncorrected standard score from baseline to 6 weeks is reported. Higher change scores indicate improved levels of functioning
Measured: Baseline, 6 weeks
Auditory Verbal Learning
The Rey auditory verbal learning task is a word-list learning task in which 15 unrelated words are presented orally (via audio recording) over three consecutive learning trials1. After each presentation, the participant is asked to recall as many of the words as he/she can. The Rey is scored by taking the sum of the number of words recalled across all trials (possible range is 0-45 words). The raw score is most commonly used for interpretation of the Rey test, with higher scores representing better episodic memory. Change from baseline to post-test follow-up at 6-weeks is reported.
Measured: Baseline, 6 weeks
Text Message Motivation.
Participant reported rating on a scale from 0-10, with 0 being no motivation and 10 being the highest motivation provided by the ecological momentary intervention text messages. Assessed at 6 weeks in the intervention group only.
Measured: 6 weeks.
Enjoyment of the Text Messages.
Participant reported rating on a scale from 0-10, with 0 being none and 10 being the highest, reported enjoyment of the ecological momentary intervention text messages. Assessed at 6 weeks.
Measured: 6 weeks.
Text Messages Helping Exercise.
Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of the ecological momentary intervention text messages helping them to exercise. Assessed at 6 weeks only
Measured: 6 weeks.
Difficulty Understanding Text Messages
Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of the ecological momentary intervention text messages being difficult to understand. Assessed at 6 weeks.
Measured: 6 weeks
Enjoyment of the Program.
Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of the enjoyment of the ecological momentary intervention.
Measured: 6 weeks.
Difficulty With the FitBit.
Participants reported rating, on a scale from 0-10 with 0 being none and 10 being the highest, of difficulty using the FitBit. Assessed at 6 weeks.
Measured: 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start2 Nov 2020
- Primary completion2 Apr 2022
- Study completion2 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Ulf G. Bronas, University of Illinois at Chicago
- Investigators
- Ulf G Bronas, PhD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507464
- Sponsor's protocol ID
- 2020-0739
- Other IDs
- 2P30AG022849-16
- Acronym
- PAIS
- Status last verified
- Jun 2023
- First submitted
- 6 Aug 2020
- Last updated
- 25 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39235836
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physical Activity Program to Disrupt Sedentary Time in Older Latinos
- ClinicalTrials.gov ID
- NCT04507464
- Acronym / sponsor ID
- PAIS / 2020-0739
- Conditions
- Sedentary Behavior, Cognitive Impairment
- Keywords
- Sedentary Behavior, Physical Activity, Cognitive Health, Older Adults, Latinos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 2 Apr 2022 (actual)
- Study completion
- 2 Apr 2022 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Posted 25 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Ecological Momentary Intervention | Experimental | Behavioral: Ecological Momentary InterventionParticipants will receive real time physical activity notifications via a wearable activity tracker and smartphone application. |
| Physical Activity Guidelines | No intervention | –Participants will be sent general guidelines for disruption of sedentary time. |
Who may qualify
- Ages
- 55 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- no history of major head trauma
- ownership of a smartphone
- ability to make video calls
Key exclusion criteria (15 listed)
- Requires assistive ambulation;
- Unstable angina,
- Claudication
- severe arthritis,
- extreme dyspnea on exertion,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecological Momentary InterventionAlso: Illumivu mEMAParticipants 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. | Behavioural | Ecological Momentary Intervention |
Primary outcome
Number of Sedentary Bouts
Time frame: Baseline, 6 weeks
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
Time in Sedentary Bouts
Time frame: Baseline, 6 weeks
Change from baseline to 6 weeks in minutes spent in sedentary bouts
14 secondary outcomes
Trail Making Test A
Time frame: Baseline, 6 weeks
Trail Making Test B
Time frame: baseline, 6 weeks
Picture Vocabulary Test
Time frame: Baseline, 6 weeks
List Sorting
Time frame: Baseline, 6 weeks
Picture Sequence
Time frame: Baseline, 6 weeks
Oral Reading Recognition Test
Time frame: Baseline, 6 weeks
Crystalized Cognition
Time frame: Baseline, 6 weeks
Auditory Verbal Learning
Time frame: Baseline, 6 weeks
Text Message Motivation.
Time frame: 6 weeks.
Enjoyment of the Text Messages.
Time frame: 6 weeks.
Text Messages Helping Exercise.
Time frame: 6 weeks.
Difficulty Understanding Text Messages
Time frame: 6 weeks
Enjoyment of the Program.
Time frame: 6 weeks.
Difficulty With the FitBit.
Time frame: 6 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39235836Bronas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf G Bronas, PhD principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecological Momentary Intervention in people with Sedentary Behavior and Cognitive Impairment, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Sedentary Bouts (time frame: Baseline, 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04507464, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.