Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2P30AG022849-16 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ecological Momentary Intervention | Experimental | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ulf G Bronas, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39235836 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ecological Momentary Intervention | Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application. 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. |
| FG001 | Physical Activity Guidelines | Participants will be sent general guidelines for disruption of sedentary time. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ecological Momentary Intervention | Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | Sedentary bouts | Baseline, 6 weeks |
|
6 weeks
no difference from clinical trials definitions
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ecological Momentary Intervention | Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application. 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ulf Bronas | University of Illinois at Chicago | 3123555886 | bronas@uic.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2021 | Apr 14, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 10, 2021 | Apr 14, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D060825 | Cognitive Dysfunction |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
|
|
| 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. |
| 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 | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 6 weeks. |
| BG001 | Physical Activity Guidelines | Participants will be sent general guidelines for disruption of sedentary time. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Physical Activity Guidelines | Participants will be sent general guidelines for disruption of sedentary time. |
|
|
| Primary | Time in Sedentary Bouts | Change from baseline to 6 weeks in minutes spent in sedentary bouts | Posted | Mean | Standard Deviation | Minutes | Baseline, 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Seconds | Baseline, 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Seconds | baseline, 6 weeks |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Number of correctly pronouced words | Baseline, 6 weeks |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | Uncorrected standard score | Baseline, 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks |
|
|
|
| Secondary | 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. | EMI ratings apply to intervention group only. | Posted | Mean | Full Range | units on a scale | 6 weeks. |
|
|
|
| Secondary | 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. | Intervention group only. | Posted | Mean | Full Range | units on a scale | 6 weeks. |
|
|
|
| Secondary | 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 | Intervention group only. | Posted | Mean | Full Range | units on a scale | 6 weeks. |
|
|
|
| Secondary | 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. | Intervention group only. | Posted | Mean | Full Range | units on a scale | 6 weeks |
|
|
|
| Secondary | 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. | Intervention group only. | Posted | Mean | Full Range | units on a scale | 6 weeks. |
|
|
|
| Secondary | 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. | Intervention group only. | Posted | Mean | Full Range | units on a scale | 6 weeks. |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Physical Activity Guidelines | Participants will be sent general guidelines for disruption of sedentary time. | 0 | 19 | 0 | 19 | 0 | 19 |
Not provided
Not provided