Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in body composition |
Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable. |
Change from Baseline to 4 month |
|
Primary |
Change in body composition |
Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable. |
Change from Baseline to 12 month |
|
Primary |
Increase in intake of fruits and vegetables |
VioScreen's dietary analysis of self reported food consumption |
Change from Baseline to 4 month |
|
Primary |
Increase in intake of fruits and vegetables |
VioScreen's dietary analysis of self reported food consumption |
Change from Baseline to 12 month |
|
Primary |
Decrease of intake of red meat/processed meat |
VioScreen's dietary analysis of self reported food consumption |
Change from Baseline to 4 month |
|
Primary |
Decrease of intake of red meat/processed meat |
VioScreen's dietary analysis of self reported food consumption |
Change from Baseline to 12 month |
|
Primary |
Increase in levels of physical activity- minutes per week |
Change of ActiGraph monitored activity |
Change from Baseline to 4 month |
|
Primary |
Increase in levels of physical activity- minutes per week |
Change of ActiGraph monitored activity |
Change from Baseline to 12 month |
|
Primary |
Increase in levels of physical activity- #times per week |
Change of ActiGraph monitored activity |
Change from Baseline to 4 month |
|
Primary |
Increase in levels of physical activity- #times per week |
Change of ActiGraph monitored activity |
Change from Baseline to 12 month |
|
Primary |
Increase in resistance training- Lower extremity strength |
Isokinetic dynamometer (HUMAC Norm, Stoughton, MA). |
Change from Baseline to 4 month |
|
Primary |
Increase in resistance training- Lower extremity strength |
Isokinetic dynamometer (HUMAC Norm, Stoughton, MA). |
Change from Baseline to 12 month |
|
Primary |
Increase in resistance training- Handgrip strength |
Takei 5401 Hand Grip Digital Dynamometer |
Change from Baseline to 4 month |
|
Primary |
Increase in resistance training- Handgrip strength |
Takei 5401 Hand Grip Digital Dynamometer |
Change from Baseline to 12 month |
|
Primary |
Increase in resistance training- Strength and endurance |
30-Second Chair Stand (Sit to Stand) |
Change from Baseline to 4 month |
|
Primary |
Increase in resistance training- Strength and endurance |
30-Second Chair Stand (Sit to Stand) |
Change from Baseline to 12 month |
|
Primary |
Change in Quality of Life- PROMIS |
PROMIS T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS measures physical function, depression, anxiety, fatigue, sleep disturbance, social roles, pain interference, social isolation, cognitive function, support, self-efficacy and sexual function. |
Change from Baseline to 4 month |
|
Primary |
Change in Quality of Life-PROMIS |
PROMIS T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS measures physical function, depression, anxiety, fatigue, sleep disturbance, social roles, pain interference, social isolation, cognitive function, support, self-efficacy and sexual function. |
Change from Baseline to 4 month |
|
Primary |
Change in Urban life stress inventory- Crisys |
Measure change of mean in positive/negative/neutral and resolved/ongoing |
Change from Baseline to 4 month |
|
Primary |
Change in Urban life stress inventory-Crisys |
Measure change of mean in positive/negative/neutral and resolved/ongoing |
Change from Baseline to 12 month |
|
Primary |
Changes in Blood Pressure |
Participants blood pressure will be measured using a digital, automated unit |
Change from Baseline to 4 month |
|
Primary |
Change in Blood Pressure |
Participants blood pressure will be measured using a digital, automated unit |
Change from Baseline to 12 month |
|
Primary |
Change in Biomarkers- Hemoglobin |
Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 4 month |
|
Primary |
Change in Biomarkers-Hemoglobin |
Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 12 month |
|
Primary |
Change in Biomarkers- A1C |
A1C blood tests measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 4 month |
|
Primary |
Change in Biomarkers- A1C |
A1C blood tests measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 12 month |
|
Primary |
Change in Biomarkers- Hormones-Testosterone |
Testosterone blood test measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 4 month |
|
Primary |
Change in Biomarkers- Hormones-Testosterone |
Testosterone blood test measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 12 month |
|
Primary |
Change in Biomarkers- Hormones- Estradiol |
Estradiol blood test measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 4 month |
|
Primary |
Change in Biomarkers- Hormones- Estradiol |
Estradiol blood test measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 12 month |
|
Primary |
Change in Biomarkers- Hormones- SHBG |
SHBG blood test measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 4 month |
|
Primary |
Change in Biomarkers- Hormones- SHBG |
SHBG blood test measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 12 month |
|
Primary |
Change in Biomarkers-Adipokines- Leptin |
Leptin blood test measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 4 month |
|
Primary |
Change in Biomarkers-Adipokines- Leptin |
Leptin,blood test measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 12 month |
|
Primary |
Change in Biomarkers-Adipokines-Adiponectin |
Adiponectin blood test measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 4 month |
|
Primary |
Change in Biomarkers-Adipokines-Adiponectin |
Adiponectin blood test measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 12 month |
|
Primary |
Change in Biomarkers-Inflammation- IL-6 |
IL-6 blood test measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 4 month |
|
Primary |
Change in Biomarkers-Inflammation- IL-6 |
IL-6 blood test measured by Wisconsin Diagnostic Laboratory Wisconsin |
Change from Baseline to 12 month |
|
Primary |
Change in Biomarkers-Inflammation-TNFa |
TNFa blood test measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 4 month |
|
Primary |
Change in Biomarkers-Inflammation-TNFa |
TNFa blood test measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 12 month |
|
Primary |
Change in Biomarkers-Insulin Resistance-C-Peptide |
C-Peptide blood test measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 4 month |
|
Primary |
Change in Biomarkers-Insulin Resistance- C-Peptide |
C-Peptide blood test measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 12 month |
|
Primary |
Change in Biomarkers-Insulin Resistance-IGF-1 |
IGF-1 blood test measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 4 month |
|
Primary |
Change in Biomarkers Insulin Resistance-IGF-1 |
IGF-1 blood test measured by Wisconsin Diagnostic Laboratory |
Change from Baseline to 12 month |
|