Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Adherence to a 12 Week Technology Supported Physical Activity Intervention |
Adherence during the 12 week intervention will be monitored continuously using study app. This measures the average percentage of days each participant randomized wore the Fitbit during weeks 1 to 12. |
12 weeks |
|
Primary |
Participant Retention |
Percentage of participants retained at the end of the 12 week intervention of those randomized [(# of participants randomized who completed at least 1 outcome assessment measure at 12 weeks)/ # randomized*100]. |
12 weeks |
|
Primary |
Intervention Reach |
Percentage of individuals randomized of those who were sent a study screening survey |
Baseline |
|
Secondary |
Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention |
Physical activity will be measured at baseline and at 12 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (=2020). |
Change from baseline to 12 weeks |
|
Secondary |
Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up |
Physical activity will be measured at baseline and at 24 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (=2020). |
Change from baseline to 24 weeks |
|
Secondary |
Change in Fatigue From Before to After a 12-Week Intervention |
Fatigue is measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. |
Change from baseline to 12 weeks |
|
Secondary |
Change in Fatigue From Pre-Intervention to 24-Week Follow-up |
Fatigue will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. |
Change from baseline to 24 weeks |
|
Secondary |
Change in Physical Function From Before to After a 12-Week Intervention |
Physical function will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. |
Change from baseline to 12 weeks |
|
Secondary |
Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up |
Physical function will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. The treatment effect is calculated as the mean difference in the change in physical function between baseline and 24-weeks for each component on versus off. |
Change from baseline to 24 weeks |
|
Secondary |
Change in Depression From Before to After a 12-Week Intervention |
Depression will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. |
Change from baseline to 12 weeks |
|
Secondary |
Change in Depression From Pre-Intervention to 24-week Follow-up |
Depression will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. |
Change from baseline to 24 weeks |
|
Secondary |
Adherence to During the Full 24-Week Study Period |
Adherence during the 24-week study period will be monitored continuously using study app. This measure the average percentage of days each randomized participant wore the Fitbit from weeks 1 to 24. |
24 weeks |
|
Secondary |
Participant Retention at 24 Week Follow-up |
Percentage of participants retained at 24 weeks of those randomized |
24 weeks |
|
Secondary |
Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional) |
Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminescent immunoassay protocol. |
Change from baseline to 12 weeks |
|
Secondary |
Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional) |
Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. |
Change from baseline to 24 weeks |
|
Secondary |
Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional) |
Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. |
Change from baseline to 12 weeks |
|
Secondary |
Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional) |
Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Higher IL-10 may have protective effects. |
Change from baseline to 24 weeks |
|
Secondary |
Change in Tumor Necrosis Factor-alpha (TNFa) From Before to After a12 Week Intervention (Optional) |
tumor necrosis factor-alpha (TNFa) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Lower values are better. |
Change from baseline to 12 weeks |
|
Secondary |
Change in Tumor Necrosis Factor-alpha (TNFa) From Pre-Intervention to 24-week Follow-up (Optional) |
tumor necrosis factor-alpha (TNFa) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. TLower values are better. |
Change from baseline to 24 weeks |
|
Secondary |
Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional) |
C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using ELISA. Lower values are better. |
Change from baseline to 12 weeks |
|
Secondary |
Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional) |
C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using standard ELISA. Lower values are better. |
Change from baseline to 24 weeks |
|
Secondary |
Change in Triglycerides From Before to After a 12 Week Intervention (Optional) |
Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. |
Change from baseline to 12 weeks |
|
Secondary |
Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional) |
Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. Lower values are better. |
Change from baseline to 24 weeks |
|
Secondary |
Change in Blood Glucose From Before to After a 12 Week Intervention (Optional) |
Blood glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. |
Change from baseline to 12 weeks |
|
Secondary |
Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional) |
Blood Glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. |
Change from baseline to 24 weeks |
|
Secondary |
Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional) |
High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. |
Change from baseline to 12 weeks |
|
Secondary |
Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional) |
High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. |
Change from baseline to 24 weeks |
|