Sedentary Behavior, Cognitive Impairment
Conditions
Keywords
Sedentary Behavior, Physical Activity, Cognitive Health, Older Adults, Latinos
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.
Interventions
BEHAVIORALEcological 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.
Sponsors
National Institute on Aging (NIA)
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
55 Years to 89 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Sedentary Bouts | 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 | Baseline, 6 weeks | Change from baseline to 6 weeks in minutes spent in sedentary bouts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Picture Vocabulary Test | Baseline, 6 weeks | 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 |
| List Sorting | Baseline, 6 weeks | 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. |
| Picture Sequence | Baseline, 6 weeks | 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. |
| Oral Reading Recognition Test | Baseline, 6 weeks | 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. |
| Crystalized Cognition | Baseline, 6 weeks | 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 |
| Auditory Verbal Learning | Baseline, 6 weeks | 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. |
| Trail Making Test A | Baseline, 6 weeks | 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. |
| Enjoyment of the Text Messages. | 6 weeks. | 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. |
| Text Messages Helping Exercise. | 6 weeks. | 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 |
| Difficulty Understanding Text Messages | 6 weeks | 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. |
| Enjoyment of the Program. | 6 weeks. | 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. |
| Difficulty With the FitBit. | 6 weeks. | 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. |
| Text Message Motivation. | 6 weeks. | 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. |
| Trail Making Test B | baseline, 6 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Physical Activity Guidelines Participants will be sent general guidelines for disruption of sedentary time. | 19 |
| Total | 39 |
Baseline characteristics
| Characteristic | Ecological Momentary Intervention | Physical Activity Guidelines | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 7 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 12 Participants | 27 Participants |
| Age, Continuous | 59.9 years STANDARD_DEVIATION 4.99 | 62.16 years STANDARD_DEVIATION 6.57 | 61 years STANDARD_DEVIATION 5.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 19 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 20 participants | 19 participants | 39 participants |
| Sex: Female, Male Female | 11 Participants | 15 Participants | 26 Participants |
| Sex: Female, Male Male | 9 Participants | 4 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 0 / 20 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
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
Time frame: Baseline, 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ecological Momentary Intervention | Number of Sedentary Bouts | -11.58 Sedentary bouts | Standard Deviation 22.02 |
| Physical Activity Guidelines | Number of Sedentary Bouts | -2.47 Sedentary bouts | Standard Deviation 28.06 |
Primary
Time in Sedentary Bouts
Change from baseline to 6 weeks in minutes spent in sedentary bouts
Time frame: Baseline, 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ecological Momentary Intervention | Time in Sedentary Bouts | -347.7 Minutes | Standard Deviation 484.98 |
| Physical Activity Guidelines | Time in Sedentary Bouts | -27.53 Minutes | Standard Deviation 811.07 |
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.
Time frame: Baseline, 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ecological Momentary Intervention | Auditory Verbal Learning | .26 score on a scale | Standard Deviation 4.04 |
| Physical Activity Guidelines | Auditory Verbal Learning | .47 score on a scale | Standard Deviation 5.23 |
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
Time frame: Baseline, 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ecological Momentary Intervention | Crystalized Cognition | 3.95 Uncorrected standard score | Standard Deviation 10.46 |
| Physical Activity Guidelines | Crystalized Cognition | .95 Uncorrected standard score | Standard Deviation 5.26 |
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.
Time frame: 6 weeks
Population: Intervention group only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ecological Momentary Intervention | Difficulty Understanding Text Messages | 0.9 units on a scale |
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.
Time frame: 6 weeks.
Population: Intervention group only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ecological Momentary Intervention | Difficulty With the FitBit. | 1.7 units on a scale |
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.
Time frame: 6 weeks.
Population: Intervention group only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ecological Momentary Intervention | Enjoyment of the Program. | 9.4 units on a scale |
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.
Time frame: 6 weeks.
Population: Intervention group only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ecological Momentary Intervention | Enjoyment of the Text Messages. | 8.8 units on a scale |
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.
Time frame: Baseline, 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ecological Momentary Intervention | List Sorting | 1.26 score on a scale | Standard Deviation 8.7 |
| Physical Activity Guidelines | List Sorting | 5.53 score on a scale | Standard Deviation 9.64 |
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.
Time frame: Baseline, 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ecological Momentary Intervention | Oral Reading Recognition Test | 6.89 Number of correctly pronouced words | Standard Deviation 19.14 |
| Physical Activity Guidelines | Oral Reading Recognition Test | 1 Number of correctly pronouced words | Standard Deviation 7.58 |
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.
Time frame: Baseline, 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ecological Momentary Intervention | Picture Sequence | 4.26 score on a scale | Standard Deviation 13.22 |
| Physical Activity Guidelines | Picture Sequence | 4.32 score on a scale | Standard Deviation 10.73 |
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
Time frame: Baseline, 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ecological Momentary Intervention | Picture Vocabulary Test | .20 score on a scale | Standard Deviation 1.49 |
| Physical Activity Guidelines | Picture Vocabulary Test | .25 score on a scale | Standard Deviation 1.27 |
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.
Time frame: 6 weeks.
Population: EMI ratings apply to intervention group only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ecological Momentary Intervention | Text Message Motivation. | 8.7 units on a scale |
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
Time frame: 6 weeks.
Population: Intervention group only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ecological Momentary Intervention | Text Messages Helping Exercise. | 8.9 units on a scale |
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.
Time frame: Baseline, 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ecological Momentary Intervention | Trail Making Test A | .43 Seconds | Standard Deviation 1.27 |
| Physical Activity Guidelines | Trail Making Test A | .31 Seconds | Standard Deviation 1.73 |
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.
Time frame: baseline, 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ecological Momentary Intervention | Trail Making Test B | -35.26 Seconds | Standard Deviation 60.35 |
| Physical Activity Guidelines | Trail Making Test B | 7.19 Seconds | Standard Deviation 46 |