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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG048785 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This pilot study is a small sample (N=46) 16-week clinical trial with a follow-up after 24-weeks among sedentary adults >60 y with a BMI >25 kg/m2 to tests the impact of a hybrid artificial intelligence behavior change system (Companion) on physical activity. Participants will be randomized to a control and intervention group. All participants will engage in a proven supervised exercise program from week 1 to 16. Only the intervention group will receive Companion from week 1 to 16.
This is a single site randomized clinical trial to test if if Companion improves and sustains free-living physical activity and sedentary behaviors in adults >60 y and improves health outcomes. Forty-six sedentary adults >60 y with a BMI >25 kg/m2 will be randomized to a control and intervention group. Both groups will undergo a 16-week supervised training program involving supervised training sessions 45-60 min, twice a week. The intervention group will additionally receive the two-way communication-based Companion meta intervention. Two-way communication during weeks 1 to 4, will focus on gathering information on the adult's motivations, preferences, habits, contexts, and usual behavior patterns to build typical individual behavior models. The model will be used to develop an adaptive physical active and sedentary behavior intervention prescription. Primary outcomes from Aim 1 and exploratory outcomes from Aim 2 will be measured at baseline and then after 16 and 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Control group will engage in a 16-week supervised exercise program and then be followed-up after 24 weeks | |
| Treatment | Experimental | Treatment group will engage in a 16-week supervised exercise program and then be followed-up after 24 weeks. In addition, the Companion will be deployed in the treatment group only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Companion | Behavioral | Companion integrates wearable sensing with the smartphone to develop a behavior-aware, virtual system that uses a "human-in-the-loop" approach to enable meaningful two-way communication. Companion builds rich models of typical behavior using sensors and context sensitive ecological momentary assessment to deliver intervention components and behavior change strategies using socially engaging, contextually salient, and tailored text-message conversations in near-real-time. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer at Baseline | Total time spent being active will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior. | Baseline |
| Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months | Total time spent being active will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior. | 4 months |
| Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months | Total time spent being active will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior. | 6 months |
| Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer at Baseline | Total time spent sedentary will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior. | Baseline |
| Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months | Total time spent sedentary will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Body Fat Measured Via Bioelectrical Impedance at Baseline | This is an exploratory outcome. The amount of fat in the body will be computed as a percentage | Baseline |
| Percent Body Fat Measured Via Bioelectrical Impedance After 4 Months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dinesh John, PhD | Northeastern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeastern Univeristy | Boston | Massachusetts | 02115 | United States |
5 participants were excluded from the study before assignment to groups. 3 chose to not continue participation and 2 were recommended to no continue participation by their personal physician. 46 participants were randomized to th control and treatment groups
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Control group will engage in a 16-week supervised exercise program and then be followed-up after 24 weeks |
| FG001 | Treatment | Treatment group will engage in a 16-week supervised exercise program and then be followed-up after 24 weeks. In addition, the Companion will be deployed in the treatment group only. Companion: Companion integrates wearable sensing with the smartphone to develop a behavior-aware, virtual system that uses a "human-in-the-loop" approach to enable meaningful two-way communication. Companion builds rich models of typical behavior using sensors and context sensitive ecological momentary assessment to deliver intervention components and behavior change strategies using socially engaging, contextually salient, and tailored text-message conversations in near-real-time. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to 16 Weeks |
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| 16 to 24 Weeks |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Control group will engage in a 16-week supervised exercise program and then be followed-up after 24 weeks |
| BG001 | Treatment | Treatment group will engage in a 16-week supervised exercise program and then be followed-up after 24 weeks. In addition, the Companion will be deployed in the treatment group only. Companion: Companion integrates wearable sensing with the smartphone to develop a behavior-aware, virtual system that uses a "human-in-the-loop" approach to enable meaningful two-way communication. Companion builds rich models of typical behavior using sensors and context sensitive ecological momentary assessment to deliver intervention components and behavior change strategies using socially engaging, contextually salient, and tailored text-message conversations in near-real-time. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer at Baseline | Total time spent being active will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior. | Accelerometer data were missing for 1 participant in the control group.This results in a discrepancy with overall participant flow table which represents the number of participants with any available data. | Posted | Mean | Standard Deviation | h/day | Baseline |
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Baseline, during face-to-face interactions, and after 4 and 16 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Control group will engage in a 16-week supervised exercise program and then be followed-up after 24 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dinesh John | Northeastern University | (801) 230-6320 | d.john@northeastern.edu |
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| 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 | May 3, 2021 | May 3, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| 4 months |
| Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months | Total time spent sedentary will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior. | 6 months |
This is an exploratory outcome. The amount of fat in the body will be computed as a percentage
| 4 months |
| Percent Body Fat Measured Via Bioelectrical Impedance After 6 Months | This is an exploratory outcome. The amount of fat in the body will be computed as a percentage | 6 months |
| Attention and Executive Function Measured Using the NIH Tool Box Measured at Baseline | This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Flanker Inhibitory Control and Attention Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Flanker Inhibitory Control and Attention Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | Baseline |
| Attention and Executive Function Measured Using the NIH Tool Box After 4 Months | This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Flanker Inhibitory Control and Attention Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Flanker Inhibitory Control and Attention Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | 4 months |
| Attention and Executive Function Measured Using the NIH Tool Box | This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Flanker Inhibitory Control and Attention Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Flanker Inhibitory Control and Attention Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | 6 months |
| Working Memory Measured Using the NIH Tool Box at Baseline | This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Picture Sequence Memory Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Picture Sequence Memory Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged accross participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | Baseline |
| Working Memory Measured Using the NIH Tool Box After 4 Months | This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Picture Sequence Memory Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Picture Sequence Memory Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | 4 months |
| Working Memory Measured Using the NIH Tool Box After 6 Months | This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Picture Sequence Memory Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Picture Sequence Memory Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | 6 months |
| Relative Processing Speed Measured Using the NIH Tool Box at Baseline | Average age-adjusted national percentile of NIH Toolbox Pattern Comparison Processing Speed Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Pattern Comparison Processing Speed Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | Baseline |
| Relative Processing Speed Measured Using the NIH Tool Box Measured After 4 Months | This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Pattern Comparison Processing Speed Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Pattern Comparison Processing Speed Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged accross participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | 4 months |
| Relative Processing Speed Measured Using the NIH Tool Box Measured After 6 Months | This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Pattern Comparison Processing Speed Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Pattern Comparison Processing Speed Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | 6 months |
| Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline | This is an exploratory outcome. | Baseline |
| Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months | This is an exploratory outcome. | 4 months |
| Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 6 Months | This is an exploratory outcome. | 6 months |
| Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline | This is an exploratory outcome. | Baseline |
| Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months | This is an exploratory outcome. | 4 months |
| Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Were Measured After 6 Months | This is an exploratory outcome. | 6 months |
| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/^2 |
|
Treatment group will engage in a 16-week supervised exercise program and then be followed-up after 24 weeks. In addition, the Companion will be deployed in the treatment group only. Companion: Companion integrates wearable sensing with the smartphone to develop a behavior-aware, virtual system that uses a "human-in-the-loop" approach to enable meaningful two-way communication. Companion builds rich models of typical behavior using sensors and context sensitive ecological momentary assessment to deliver intervention components and behavior change strategies using socially engaging, contextually salient, and tailored text-message conversations in near-real-time. |
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| Primary | Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months | Total time spent being active will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior. | There were 2 participants lost to followup in both groups and 1 participant was missing accelerometer data in the control group. This results in a discrepancy with overall participant flow table which represents the number of participants with any available data. | Posted | Mean | Standard Deviation | h/day | 4 months |
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| Primary | Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months | Total time spent being active will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior. | 5 and 6 participants were lost to followup and additionally, accelerometer data were missing for 1 participant each in the control and treatment groups respectively. This results in a discrepancy with overall participant flow table which represents the number of participants with any available data. | Posted | Mean | Standard Deviation | h/day | 6 months |
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| Primary | Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer at Baseline | Total time spent sedentary will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior. | Accelerometer data were missing for 1 participant in the control group.This results in a discrepancy with overall participant flow table which represents the number of participants with any available data. | Posted | Mean | Standard Deviation | h/day | Baseline |
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| Primary | Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months | Total time spent sedentary will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior. | There were 2 participants lost to followup in both groups and 1 participant was missing accelerometer data in the control group. This results in a discrepancy with overall participant flow table which represents the number of participants with any available data. | Posted | Mean | Standard Deviation | h/day | 4 months |
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| Primary | Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months | Total time spent sedentary will be measured using a body worn motion sensor (accelerometer) during waking hours over a period of one week. Measures for each day (hours) will be averaged to obtain a representative estimate of daily habitual behavior. | 5 and 6 participants were lost to followup and additionally, accelerometer data were missing for 1 participant each in the control and treatment groups respectively. This results in a discrepancy with overall participant flow table which represents the number of participants with any available data. | Posted | Mean | Standard Deviation | h/day | 6 months |
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| Other Pre-specified | Percent Body Fat Measured Via Bioelectrical Impedance at Baseline | This is an exploratory outcome. The amount of fat in the body will be computed as a percentage | Posted | Mean | Standard Deviation | % body fat | Baseline |
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| Other Pre-specified | Percent Body Fat Measured Via Bioelectrical Impedance After 4 Months | This is an exploratory outcome. The amount of fat in the body will be computed as a percentage | Missing data from 2 participants who were lost to follow-up in each group | Posted | Mean | Standard Deviation | % body fat | 4 months |
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| Other Pre-specified | Percent Body Fat Measured Via Bioelectrical Impedance After 6 Months | This is an exploratory outcome. The amount of fat in the body will be computed as a percentage | 5 and 6 participants from the control and treatment group were lost to followup, respectively. | Posted | Mean | Standard Deviation | % body fat | 6 months |
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| Other Pre-specified | Attention and Executive Function Measured Using the NIH Tool Box Measured at Baseline | This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Flanker Inhibitory Control and Attention Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Flanker Inhibitory Control and Attention Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | Posted | Mean | Standard Deviation | average age-adjusted percentile | Baseline |
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| Other Pre-specified | Attention and Executive Function Measured Using the NIH Tool Box After 4 Months | This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Flanker Inhibitory Control and Attention Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Flanker Inhibitory Control and Attention Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | Two participants each were lost to follow-up in the control and treatment groups | Posted | Mean | Standard Deviation | average age-adjusted percentile | 4 months |
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| Other Pre-specified | Attention and Executive Function Measured Using the NIH Tool Box | This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Flanker Inhibitory Control and Attention Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Flanker Inhibitory Control and Attention Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | 5 and 6 participants from the control and treatment group were lost to followup, respectively. | Posted | Mean | Standard Deviation | average age-adjusted score | 6 months |
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| Other Pre-specified | Working Memory Measured Using the NIH Tool Box at Baseline | This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Picture Sequence Memory Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Picture Sequence Memory Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged accross participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | Posted | Mean | Standard Deviation | average age-adjusted percentile | Baseline |
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| Other Pre-specified | Working Memory Measured Using the NIH Tool Box After 4 Months | This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Picture Sequence Memory Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Picture Sequence Memory Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | Two participants each from the control and treatment group were lost to followup. | Posted | Mean | Standard Deviation | average age-adjusted-percentile | 4 months |
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| Other Pre-specified | Working Memory Measured Using the NIH Tool Box After 6 Months | This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Picture Sequence Memory Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Picture Sequence Memory Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | 5 and 6 participants from the control and treatment group were lost to followup, respectively. | Posted | Mean | Standard Deviation | average age-adjusted percentile | 6 months |
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| Other Pre-specified | Relative Processing Speed Measured Using the NIH Tool Box at Baseline | Average age-adjusted national percentile of NIH Toolbox Pattern Comparison Processing Speed Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Pattern Comparison Processing Speed Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | Posted | Mean | Standard Deviation | Average age-adjusted percentile | Baseline |
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| Other Pre-specified | Relative Processing Speed Measured Using the NIH Tool Box Measured After 4 Months | This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Pattern Comparison Processing Speed Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Pattern Comparison Processing Speed Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged accross participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | Two participants each from the control and treatment group were lost to followup. | Posted | Mean | Standard Deviation | Average age-adjusted percentile | 4 months |
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| Other Pre-specified | Relative Processing Speed Measured Using the NIH Tool Box Measured After 6 Months | This is an exploratory outcome - Average age-adjusted national percentile of NIH Toolbox Pattern Comparison Processing Speed Test score measured at Baseline. Each participant's raw score on the NIH Toolbox Pattern Comparison Processing Speed Test is standardized against a nationally representative sample to get the participant's national percentile. Percentiles are then adjusted for age and averaged across participants. Percentiles can range from 0 to 100, with a higher percentile indicating better performance. | Posted | Mean | Standard Deviation | Average age-adjusted percentile | 6 months |
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| Other Pre-specified | Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline | This is an exploratory outcome. | Posted | Mean | Standard Deviation | mg/dL | Baseline |
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| Other Pre-specified | Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months | This is an exploratory outcome. | Two participants each from the control and treatment group were lost to followup. | Posted | Mean | Standard Deviation | mg/dL | 4 months |
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| Other Pre-specified | Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 6 Months | This is an exploratory outcome. | 5 and 6 participants from the control and treatment group were lost to followup, respectively. | Posted | Mean | Standard Deviation | mg/dL | 6 months |
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| Other Pre-specified | Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline | This is an exploratory outcome. | Posted | Mean | Standard Deviation | mg/dL | Baseline |
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| Other Pre-specified | Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months | This is an exploratory outcome. | Two participants from the control and treatment group were lost to followup. | Posted | Mean | Standard Deviation | mg/dL | 4 months |
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| Other Pre-specified | Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Were Measured After 6 Months | This is an exploratory outcome. | 5 and 6 participants from the control and treatment group were lost to followup, respectively. | Posted | Mean | Standard Deviation | mg/dL | 6 months |
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| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Treatment | Treatment group will engage in a 16-week supervised exercise program and then be followed-up after 24 weeks. In addition, the Companion will be deployed in the treatment group only. Companion: Companion integrates wearable sensing with the smartphone to develop a behavior-aware, virtual system that uses a "human-in-the-loop" approach to enable meaningful two-way communication. Companion builds rich models of typical behavior using sensors and context sensitive ecological momentary assessment to deliver intervention components and behavior change strategies using socially engaging, contextually salient, and tailored text-message conversations in near-real-time. | 0 | 23 | 0 | 23 | 0 | 23 |
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