Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Percent body weight loss |
Total percent body weight loss will be reported at 12 months based on the following formula: (Starting baseline weight minus current weight) / (starting baseline weight) x 100 equals % of body weight loss. |
12 months |
|
| Primary |
Change in Body Mass Index (BMI) |
Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches x Height in inches)) x 703 |
Baseline, 12 months |
|
| Primary |
Change in visceral adiposity distribution |
Change in visceral adiposity distribution measured using dual energy X-ray absorptiometry (DEXA). |
Baseline, 12 months |
|
| Secondary |
Change in Blood Pressure |
Measured in millimeters of mercury (mmHg) |
Baseline, 12 months |
|
| Secondary |
Change in point of care glucose |
Change in estimated glucose value (mg/dl) obtained from point of care fingerstick testing. |
Baseline, 12 months |
|
| Secondary |
Change in quality of diet |
Change in quality of diet will be assessed by the Mini-EAT (Eating Assessment Tool). The Mini-EAT is a 9 item questionnaire that asks subjects how often they eat different types of foods (e.g. fruits, vegetables, legumes, etc.). Subjects respond on a scale of "I do not eat it at all" to "6 or more servings per day." Higher scores on the Mini-EAT represent a better quality of diet. |
Baseline, 12 months |
|
| Secondary |
Change in psychosocial distress as measured by Screening Tool for Psychological Distress (STOP-D) |
Psychosocial distress will be measured by the STOP-D survey. The STOP-D survey asks subjects to rate how often over the last 2 weeks they have felt depressed, anxious, stressed, angry, or lacking social support on a scale of 0-Not at all to 9-Severely. Each item is scored separately without a summed score for overall distress. Higher individual scores on the STOP-D items represent worse psychosocial distress. |
Baseline, 12 months |
|
| Secondary |
Change in psychosocial distress as measured by Impact of Event Scale-Revised (IES-R) |
Psychosocial distress will be measured by the IES-R. The IES-R is a questionnaire which asks subjects to rate how distressed or bothered during the past seven days they have been by difficulties that people sometimes have after stressful life events. Responses can range from 0-Not at all to 4-Extremely. Items on the questionnaire are grouped into 3 subscales: Intrusion, Avoidance, and Hyperarousal with scores on each subscale being the mean item response of all items in that group, thus scores for each subscale also range from 0 to 4. Higher scores are indicative of more psychosocial distress following the specific life event of focus. |
Baseline, 12 months |
|
| Secondary |
Change in psychosocial distress as measured by Adverse Childhood Experience (ACE) Questionnaire |
Psychosocial distress will be measured by the ACE Questionnaire. The ACE Questionnaire asks subjects various questions regarding life experiences from the first 18 years of life that may be considered adverse experiences (e.g. parental abuse, neglect, parental divorce, etc.). Subjects answer each question with a yes or no selection. The more questions answered yes represents worse psychosocial distress. |
Baseline, 12 months |
|
| Secondary |
Change in functional aerobic capacity (VO2 Max) |
VO2 Max is measured as milliliters of oxygen per kilogram of body weight per minute (ml/kg/min) during cardiopulmonary exercise test |
Baseline, 12 months |
|
| Secondary |
Change in artificial intelligence electrocardiogram (AI-ECG) age |
AI-ECG age is the subject's predicted age based on artificial intelligence analysis of electrocardiograms (ECGs). |
Baseline, 12 months |
|
| Secondary |
Change in E/e' |
E/e' will be measured using transthoracic echocardiography (TTE). It is defined as the ratio of peak early diastolic mitral inflow velocity (E) and peak early diastolic mitral annular velocity (e') and will be used to assess left ventricular diastolic function. |
Baseline, 12 months |
|
| Secondary |
Change in Peak Tricuspid Regurgitation (TR) Velocity |
Peak TR Velocity (m/s) will be measured using transthoracic echocardiography (TTE) to assess left ventricular diastolic function. |
Baseline, 12 months |
|
| Secondary |
Change in Right Atrial (RA) Pressure |
RA pressure (mm Hg) will be measured by transthoracic echocardiography (TTE) to assess left ventricular diastolic function. |
Baseline, 12 months |
|
| Secondary |
Change in Left Atrial (LA) volume index |
LA volume index (ml/m^2) will be measured by transthoracic echocardiography (TTE) to assess left ventricular diastolic function. |
Baseline, 12 months |
|
| Secondary |
Change in physical activity |
Average number of steps a subject takes daily as collected by an Apple watch worn by subjects for the duration of the study. |
Baseline, 12 months |
|
| Secondary |
Change in heart rate with detection of arrhythmia |
Average number of arrhythmias identified by an Apple watch worn by subjects for the duration of the study. |
Baseline, 12 months |
|
| Secondary |
Change in cardio fitness |
Fitness level reported as high/above average/below average/low as collected by an Apple watch worn by subjects for the duration of the study. |
Baseline, 12 months |
|
| Secondary |
Change in six-minute walk test |
Measurement (meters) of distance a person can walk on flat ground in 6 minutes collected by an Apple watch worn by subjects for the duration of the study. |
Baseline, 12 months |
|
| Secondary |
Change in psychosocial distress as measured by the Weight Bias Internalization-Modified (WBIS-M) scale |
The WBIS-M is a 11-item instrument for measuring the extent to which overweight individuals think of themselves in terms of prevalent negative stereotypes about overweight and overweight individuals. Respondents can express their level of agreement on a 7-point Likert scale ranging from 'strongly disagree' (1) to 'strongly agree' (7). Items 1 and 9 need to be scored reversely. Scores are averaged to create a composite score and higher scores represent greater psychosocial distress. |
Baseline, 12 months |
|
