Exercise, Physical Activity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCompanion
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.
Sponsors
National Institute on Aging (NIA)
Northeastern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 60 years and above- This intervention study focusses on this population demographic. * Participants have a body mass index greater than 25 kg/m2- This threshold for BMI is used to classify an adult as overweight or obese * No conditions preventing participation in physical activity lasting 10 to 30 min- Such conditions will limit prescription of physical activity/exercise components of the training program and that promoted using Companion. * Have a smart phone- The absence of a smart phone will limit the ability of remote communication with the study participant using Companion.
Exclusion criteria
* Engage in structured physical activity for more than 2 days/week lasting 30 min/session- Physically active participants will not be representative of typical adults \>60 y. Being active prior to study participation may mask the effects of the intervention. * Regularly use any assistive device for walking- Use of an assistive device would limit the ability to engage in prescribed physical activity. Future work can be tailored for sub-groups in the demographic being studied. * Likely to alter medications pertaining to cardiovascular or metabolic health- Altering medications during the study will influence change in selected outcome measures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer at Baseline | 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. |
| Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months | 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. |
| Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months | 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. |
| Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer at Baseline | 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. |
| Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months | 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. |
| Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Working Memory Measured Using the NIH Tool Box at Baseline | 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. |
| Working Memory Measured Using the NIH Tool Box After 4 Months | 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. |
| Working Memory Measured Using the NIH Tool Box After 6 Months | 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. |
| Relative Processing Speed Measured Using the NIH Tool Box at Baseline | 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. |
| Relative Processing Speed Measured Using the NIH Tool Box Measured After 4 Months | 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. |
| Relative Processing Speed Measured Using the NIH Tool Box Measured After 6 Months | 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. |
| Percent Body Fat Measured Via Bioelectrical Impedance at Baseline | Baseline | This is an exploratory outcome. The amount of fat in the body will be computed as a percentage |
| Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months | 4 months | This is an exploratory outcome. |
| Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 6 Months | 6 months | This is an exploratory outcome. |
| Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline | Baseline | This is an exploratory outcome. |
| Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months | 4 months | This is an exploratory outcome. |
| Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Were Measured After 6 Months | 6 months | This is an exploratory outcome. |
| Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline | Baseline | This is an exploratory outcome. |
| Percent Body Fat Measured Via Bioelectrical Impedance After 4 Months | 4 months | This is an exploratory outcome. The amount of fat in the body will be computed as a percentage |
| Percent Body Fat Measured Via Bioelectrical Impedance After 6 Months | 6 months | This is an exploratory outcome. The amount of fat in the body will be computed as a percentage |
| Attention and Executive Function Measured Using the NIH Tool Box Measured at Baseline | 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. |
| Attention and Executive Function Measured Using the NIH Tool Box After 4 Months | 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. |
| Attention and Executive Function Measured Using the NIH Tool Box | 6 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. |
Countries
United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Control Control group will engage in a 16-week supervised exercise program and then be followed-up after 24 weeks | 23 |
| 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. | 23 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 16 to 24 Weeks | Lost to Follow-up | 3 | 4 |
| Baseline to 16 Weeks | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Control | Treatment | Total |
|---|---|---|---|
| Age, Continuous | 72.7 years STANDARD_DEVIATION 6.1 | 68.9 years STANDARD_DEVIATION 6.5 | 71 years STANDARD_DEVIATION 6.5 |
| BMI | 30.5 kg/^2 STANDARD_DEVIATION 3.8 | 30.4 kg/^2 STANDARD_DEVIATION 4.9 | 30.4 kg/^2 STANDARD_DEVIATION 4.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 19 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 19 Participants | 36 Participants |
| Sex: Female, Male Female | 13 Participants | 18 Participants | 31 Participants |
| Sex: Female, Male Male | 10 Participants | 5 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
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.
Time frame: 4 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months | 1.5 h/day | Standard Deviation 0.2 |
| Treatment | Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months | 1.5 h/day | Standard Deviation 0.2 |
p-value: 0.78Mixed Models Analysis
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months | 1.5 h/day | Standard Deviation 0.24 |
| Treatment | Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months | 1.5 h/day | Standard Deviation 0.24 |
p-value: 0.56Mixed Models Analysis
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer at Baseline | 1.3 h/day | Standard Deviation 0.5 |
| Treatment | Physical Activity Hours Per Day Measured Using a Body-worn Accelerometer at Baseline | 1.6 h/day | Standard Deviation 0.5 |
p-value: 0.037Mixed Models Analysis
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.
Time frame: 4 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months | 10.4 h/day | Standard Deviation 1.9 |
| Treatment | Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 4 Months | 9.6 h/day | Standard Deviation 1.9 |
p-value: 0.18Mixed Models Analysis
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months | 10.3 h/day | Standard Deviation 1.8 |
| Treatment | Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer After 6 Months | 10.2 h/day | Standard Deviation 1.7 |
p-value: 0.86Mixed Models Analysis
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer at Baseline | 10.6 h/day | Standard Deviation 2 |
| Treatment | Sedentary Behavior Hours Per Day Measured Using a Body-worn Accelerometer at Baseline | 10.2 h/day | Standard Deviation 2 |
p-value: 0.4Mixed Models Analysis
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.
Time frame: 6 months
Population: 5 and 6 participants from the control and treatment group were lost to followup, respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Attention and Executive Function Measured Using the NIH Tool Box | 50.3 average age-adjusted score | Standard Deviation 23.2 |
| Treatment | Attention and Executive Function Measured Using the NIH Tool Box | 55.3 average age-adjusted score | Standard Deviation 23.8 |
p-value: 0.53Mixed Models Analysis
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.
Time frame: 4 months
Population: Two participants each were lost to follow-up in the control and treatment groups
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Attention and Executive Function Measured Using the NIH Tool Box After 4 Months | 46.0 average age-adjusted percentile | Standard Deviation 25.1 |
| Treatment | Attention and Executive Function Measured Using the NIH Tool Box After 4 Months | 52.2 average age-adjusted percentile | Standard Deviation 25.5 |
p-value: 0.43Mixed Models Analysis
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Attention and Executive Function Measured Using the NIH Tool Box Measured at Baseline | 36.2 average age-adjusted percentile | Standard Deviation 25.3 |
| Treatment | Attention and Executive Function Measured Using the NIH Tool Box Measured at Baseline | 42.4 average age-adjusted percentile | Standard Deviation 25.3 |
p-value: 0.41Mixed Models Analysis
Other Pre-specified
Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months
This is an exploratory outcome.
Time frame: 4 months
Population: Two participants each from the control and treatment group were lost to followup.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months | 127.7 mg/dL | Standard Deviation 29.4 |
| Treatment | Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months | 115.9 mg/dL | Standard Deviation 29.4 |
p-value: 0.2Mixed Models Analysis
Other Pre-specified
Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 6 Months
This is an exploratory outcome.
Time frame: 6 months
Population: 5 and 6 participants from the control and treatment group were lost to followup, respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 6 Months | 124.7 mg/dL | Standard Deviation 27.2 |
| Treatment | Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 6 Months | 110.7 mg/dL | Standard Deviation 27.8 |
p-value: 0.13Mixed Models Analysis
Other Pre-specified
Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline
This is an exploratory outcome.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline | 126.1 mg/dL | Standard Deviation 30 |
| Treatment | Blood Glucose Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline | 112.3 mg/dL | Standard Deviation 30 |
p-value: 0.12Mixed Models Analysis
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
Time frame: 4 months
Population: Missing data from 2 participants who were lost to follow-up in each group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Percent Body Fat Measured Via Bioelectrical Impedance After 4 Months | 38.2 % body fat | Standard Deviation 5.6 |
| Treatment | Percent Body Fat Measured Via Bioelectrical Impedance After 4 Months | 40.5 % body fat | Standard Deviation 5.6 |
p-value: 0.19Mixed Models Analysis
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
Time frame: 6 months
Population: 5 and 6 participants from the control and treatment group were lost to followup, respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Percent Body Fat Measured Via Bioelectrical Impedance After 6 Months | 37.7 % body fat | Standard Deviation 5.2 |
| Treatment | Percent Body Fat Measured Via Bioelectrical Impedance After 6 Months | 40.5 % body fat | Standard Deviation 5.1 |
p-value: 0.12Mixed Models Analysis
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Percent Body Fat Measured Via Bioelectrical Impedance at Baseline | 38.9 % body fat | Standard Deviation 5.8 |
| Treatment | Percent Body Fat Measured Via Bioelectrical Impedance at Baseline | 41.1 % body fat | Standard Deviation 5.8 |
p-value: 0.21Mixed Models Analysis
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Relative Processing Speed Measured Using the NIH Tool Box at Baseline | 39.7 Average age-adjusted percentile | Standard Deviation 38.2 |
| Treatment | Relative Processing Speed Measured Using the NIH Tool Box at Baseline | 52.7 Average age-adjusted percentile | Standard Deviation 38.2 |
p-value: 0.25Mixed Models Analysis
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.
Time frame: 4 months
Population: Two participants each from the control and treatment group were lost to followup.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Relative Processing Speed Measured Using the NIH Tool Box Measured After 4 Months | 43.5 Average age-adjusted percentile | Standard Deviation 37.1 |
| Treatment | Relative Processing Speed Measured Using the NIH Tool Box Measured After 4 Months | 52.0 Average age-adjusted percentile | Standard Deviation 37.4 |
p-value: 0.46Mixed Models Analysis
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Relative Processing Speed Measured Using the NIH Tool Box Measured After 6 Months | 49.0 Average age-adjusted percentile | Standard Deviation 34.3 |
| Treatment | Relative Processing Speed Measured Using the NIH Tool Box Measured After 6 Months | 58.6 Average age-adjusted percentile | Standard Deviation 34.3 |
p-value: 0.41Mixed Models Analysis
Other Pre-specified
Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months
This is an exploratory outcome.
Time frame: 4 months
Population: Two participants from the control and treatment group were lost to followup.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months | 161.0 mg/dL | Standard Deviation 40.5 |
| Treatment | Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured After 4 Months | 165.4 mg/dL | Standard Deviation 38.6 |
p-value: 0.72Mixed Models Analysis
Other Pre-specified
Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline
This is an exploratory outcome.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline | 156.0 mg/dL | Standard Deviation 41.3 |
| Treatment | Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Measured at Baseline | 156.8 mg/dL | Standard Deviation 39.5 |
p-value: 0.94Mixed Models Analysis
Other Pre-specified
Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Were Measured After 6 Months
This is an exploratory outcome.
Time frame: 6 months
Population: 5 and 6 participants from the control and treatment group were lost to followup, respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Were Measured After 6 Months | 152.9 mg/dL | Standard Deviation 37.5 |
| Treatment | Total Cholesterol Measured Using a Cardiocheck Fingerstick Blood Sample Were Measured After 6 Months | 165.2 mg/dL | Standard Deviation 36.4 |
p-value: 0.33Mixed Models Analysis
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.
Time frame: 4 months
Population: Two participants each from the control and treatment group were lost to followup.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Working Memory Measured Using the NIH Tool Box After 4 Months | 62.1 average age-adjusted-percentile | Standard Deviation 28.2 |
| Treatment | Working Memory Measured Using the NIH Tool Box After 4 Months | 61.7 average age-adjusted-percentile | Standard Deviation 28.6 |
p-value: 0.96Mixed Models Analysis
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.
Time frame: 6 months
Population: 5 and 6 participants from the control and treatment group were lost to followup, respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Working Memory Measured Using the NIH Tool Box After 6 Months | 62.2 average age-adjusted percentile | Standard Deviation 26.1 |
| Treatment | Working Memory Measured Using the NIH Tool Box After 6 Months | 63.3 average age-adjusted percentile | Standard Deviation 26.4 |
p-value: 0.91Mixed Models Analysis
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Working Memory Measured Using the NIH Tool Box at Baseline | 59.2 average age-adjusted percentile | Standard Deviation 28.8 |
| Treatment | Working Memory Measured Using the NIH Tool Box at Baseline | 59.0 average age-adjusted percentile | Standard Deviation 29 |
p-value: 0.98Mixed Models Analysis