Table 1.
Inclusion and exclusion criteria
| Pre-screening (Electronic health record data) |
PCP Clearance | Screening (Patient reports by phone or online) |
Baseline Visit (In-person interview, physical exam and, if clinically indicated, study physician clearance) |
|
|---|---|---|---|---|
| Inclusion Criteria: (patients will be included if meeting all of the following) | ||||
| Ethnicity: All ethnic groups | √ | |||
| Gender: Both men and women | √ | |||
| Age: ≥18 years | √ | |||
| Body mass index ≥30.0 kg/m2 (non-Asians) or ≥27.0 kg/m2 (Asians) | √ | √ | ||
| Clinically significant depression PHQ-9 ≥10 | √ | |||
| PAMF patient for ≥1 year and seen in primary care at least once in the preceding 24 months | √ | |||
| Able and willing to enroll and provide written, informed consent, i.e., to: meet the time and data collection requirements of the study; be randomized to one of two intervention arms; participate in follow-up for 24 months; and allow extraction of relevant information from their medical records. | √ | |||
| Exclusion Criteria: (patients will be excluded if meeting any of the following) | ||||
| Active suicidal ideation per PHQ-9 interview that includes active plan and/or intent (item #9 ≥2) | √ | √ | ||
| Any Axis I disorder other than Minor or Major Depressive Disorder and/or Dysthymia, with the exception of any comorbid Anxiety Disorder | √ | √ | ||
| Active Bulimia Nervosa within the past 3 months (however Binge Eating Disorder without purging is not an exclusionary condition) | √ | √ | ||
| Active alcohol or substance use disorder (including prescription drugs) | √ | √ | √ | |
| Ongoing psychiatric care with a provider outside of PAMF | √ | |||
| Had bariatric surgery within the past 12 months or plan to undergo bariatric surgery during the study period | √ | √ | √ | |
| Pre-existing diabetes (other than during pregnancy) | √ | √ | √ | √ |
| Pre-existing cardiovascular disease: e.g., coronary heart disease (myocardial infarction, angina pectoris, percutaneous coronary intervention, and coronary artery bypass graft surgery), cerebrovascular disease (stroke, transient ischemic attack), peripheral vascular disease, heart failure, or aortic aneurysm. | √ | √ | √ | √ |
| Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past year | √ | √ | √ | |
| Severe medical comorbidities that require aggressive treatment, e.g., stage 4 or greater renal disease, liver failure | √ | √ | √ | |
| Diagnosis of a terminal illness and/or residence in a long-term care facility | √ | √ | ||
| Cognitive impairment based on the Callahan 6-item screener | √ | |||
| Inability to speak, read or understand English | √ | √ | √ | √ |
| Having no reliable telephone service, or no regular Internet access via a computer and/or mobile device (e.g., smartphone)* | √ | |||
| Plan to move out of the area or transfer care outside PAMF during the study period | √ | |||
| Currently pregnant, lactating, or planning to become pregnant during the study period | √ | √ | √ | √ |
| Already enrolled, or planning to enroll, in a research study that would limit full participation in the study or confound the observation and interpretation of the study’s findings | √ | |||
| Family/household member of another participant or of a staff member | √ | √ | ||
| Investigator discretion for clinical safety or protocol adherence reasons | √ |
*
We do not employ a behavioral run-in for technology use (typical in efficacy trials) as an inclusion criterion because of the importance of balancing scientific rigor and generalizability in this type 1 hybrid design RCT. It is an integral part of the intervention curriculum that the coach instructs on, and helps troubleshoot issues with, technologies (e.g., MyFitnessPal and Fitbit websites and mobile applications) used in the intervention, as would be expected if the intervention were delivered in routine practice.