Table 3.
List of measures and data collection schedule.
| Study Measures | Instrument | Collection Method | Month
|
|||||
|---|---|---|---|---|---|---|---|---|
| Screening | 0 | 6 | 12 | 18 | 24 | |||
| Eligibility Screening | ||||||||
| Depression severity | Patient Health Questionnaire-9 (PHQ-9 and Dysthymia questions) | Self-report | x | |||||
| Suicidal ideation | PHQ-9 (item #9 ≥2) | Self-report | x | |||||
| Bulimia nervosa | PHQ eating disorder module | Self-report | x | |||||
| Alcohol/substance abuse | CAGE Adapted to Include Drugs (CAGE-AID) | Self-report | x | |||||
| Cognitive Impairment | 6-item Screener | Interview | x | |||||
| Primary/Secondary Outcomes | ||||||||
| BMI (height) | Height | Biophysical | x | |||||
| BMI (weight) | Weight | Biophysical | x | x | x | x | x | |
| Depression severity treatment response, and remission | Depression symptom Checklist-20 (SCL-20) | Self-report | x | x | x | x | x | |
| Cardiovascular risk factors | Blood pressure, waist circumference | Biophysical | x | x | x | x | x | |
| Obesity-specific health related questions | Obesity-related Problem Scale | Self-report | x | x | x | x | x | |
| Anxiety | Generalized Anxiety Disorder Scale (GAD-7); Panic Disorder module of the Mini-International Neuropsychiatric Interview (MINI) | Self-report | x | x | x | x | x | |
| Disability | Sheehan Disability Scale | Self-report | x | x | x | x | x | |
| Generic health related quality of life | SF-8 Health Survey | Self-report | x | x | x | x | x | |
| Utility based quality of life | EuroQOL-5D-5L | Self-report | x | x | x | x | x | |
| Direct medical costs, direct nonmedical costs | Health care utilization: from electronic health record (EHR); intervention cost: coach time, survey lifestyle coach for Intervention process accounting, intervention-related patient “out-of-pocket” costs. | EHR; process documentation; self-report | x | x | x | x | x | |
| Absenteeism-Presenteeism questionnaire | Self-report | x | x | x | x | x | ||
| Participant Expense Survey | Self-report | x | x | x | x | x | ||
| Medication use, general wellness services, and out of network health care utilization questionnaire | Interview | x | x | x | x | x | ||
| Potential effect modifiers | ||||||||
| Sociodemographics | Age, gender, education, race/ethnicity | Self-report | x | |||||
| Posttraumatic stress disorder (PTSD) | 17-item PTSD checklist – Civilian Version (PCL-C) | Self-report | x | |||||
| Potential effect mediators | ||||||||
| Dietary intake | 24-hr diet recalls | Interview | x | x | x | x | x | |
| Physical activity | 7-day Physical Activity Recall | Interview | x | x | x | x | x | |
| Problem solving | Social Problem-Solving Inventory-Revised: Short Form | Self-report | x | x | x | x | x | |
| Sleep habits and quality | PROMIS Sleep Disturbance and Sleep Impairment Scales | Self-report | x | x | x | x | x | |
| Safety | ||||||||
| Activity | Rose Angina and Peripheral Vascular Disease Questionnaires | Self-report | x | x | x | x | x | |
| Severe high or low blood pressure | Blood pressure | Biophysical | x | x | x | x | x | |
| Adverse Events (AE) | AE form | Interview | x | x | x | x | x | |
| Self-harm risk | SCL-20 suicidality item | Self-report | x | x | x | x | x | |