Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in body mass index (BMI) status |
The main outcomes measures will be height (meters), weight (kg), and BMI (kg/m^2). Height will be measured to assess consistency in height measurements. Weight will be measured to assess trends in weight over the time span of the intervention. BMI will be measured as a product of weight and height to obtain an appropriate metric that accounts for these measures, and is the standard measure to assess weight progression in weight intervention studies. |
Baseline up to 12 months |
|
Secondary |
Adherence |
Compliance with app intervention will be measured by daily interaction with the application and the coach. A point system has been designed in the application to measure compliance with the app intervention, measured by +/- weight measured daily, logging of problem foods, logging of snacking panel, and logging of meals. The coach interacts with the participants through text daily, and through phone calls weekly. |
Up to 12 months |
|
Secondary |
Fasting lab test analysis: HbA1c |
HbA1c: Glycated hemoglobin (A1C) test result reflects your average blood sugar level for the past two to three months. Specifically, the A1C test measures what percentage of your hemoglobin is coated with sugar. The healthy range is between 4% and 5.6% |
At four months up to 12 months |
|
Secondary |
Fasting lab test analysis: Total cholesterol |
Total cholesterol: This measures the overall amount of cholesterol in your blood. The healthy range is < 170 mg/dL |
At four months up to 12 months |
|
Secondary |
Fasting lab test analysis: Low density lipoprotein |
LDL: low density lipoprotein (LDL) is the bad cholesterol in your blood. The healthy range is <100 mg/dL |
At four months up to 12 months |
|
Secondary |
Fasting lab test analysis: High density lipoprotein |
HDL: high density lipoprotein (HDL) is the good cholesterol in your blood. The healthy range is > 45 mg/dL |
At four months up to 12 months |
|
Secondary |
Fasting lab test analysis: triglycerides |
TG: triglycerides (TG) are a type of lipid in your blood. The healthy range is < 150 mg/dL |
At four months up to 12 months |
|
Secondary |
Fasting lab test analysis: aspartate/alanine aminotransferase |
AST/ALT: aspartate/alanine aminotransferase (AST/ALT) are liver enzymes to measure liver health. The healthy range or AST is 10-34 IU/L and the healthy range for ALT is 8-37 IU/L. |
At four months up to 12 months |
|
Secondary |
Fasting lab test analysis: glucose |
Glucose: This measures the amount of sugar in your blood. We measure this after fasting for 8 hours. The healthy range is 70-99 mg/dL |
At four months up to 12 months |
|
Secondary |
Yale Food Addiction Scale |
visual analog scale (1: never to 5:always). Higher scores may suggest more addictive like eating |
Up to 12 months |
|
Secondary |
Center for epidemiologic studies depression scale |
4 categorical options (never/rarely, sometimes, moderately, all of the time). A higher score suggests utility for screening for depression |
Up to 12 months |
|
Secondary |
Perceived stress scale |
Likert Scale (0: never to 4:very often). Higher scores suggests higher stress |
Up to 12 months |
|
Secondary |
Satisfaction with program |
Measured by "Satisfaction Survey". This Likert Scale will be completed by the participant and their parent at the end of the study. This scale uses a Likert Scale where 1 = completely disagree to 7 = completely agree. Higher scores suggest greater satisfaction with the intervention. |
Up to 12 months |
|
Secondary |
Demographic questionnaire |
10 questions with varying options to inquire about common demographic questions (gender, age, primary language, etc). Questions are descriptive in nature and no score is assigned. |
Up to 12 months |
|
Secondary |
Food craving questionnaire |
Likert scale (1: never to 5: always). A higher score suggests higher degrees of food cravings |
Up to 12 months |
|
Secondary |
Binge eating disorder screen |
4 categorical options (never/rarely, sometimes, often, always). A higher score suggests utility for screening for binge eating disorder |
Up to 12 months |
|
Secondary |
Physical activity questionnaire |
participants identify number of times (0 to more than 7) that they conducted a particular physical activity in the past 7 days. This includes skipping, rowing, etc. |
Up to 12 months |
|
Secondary |
S weight |
Likert scale (1: strongly disagree to 5: strongly agree). Higher scores indicates more motivation for change in weight |
Up to 12 months |
|
Secondary |
Height encounters questionnaire |
six questions about the participants health care utilization in the past month. Questions are descriptive in nature and no score is assigned. |
Up to 12 months |
|