Latest1 information on COVID-19
©2022 Stanford Medicine
Recruiting
Trial ID: NCT02246413
RCT on Co-management of Obesity, Depression, and Elevated CVD Risk in Primary Care-- Engaging Self-regulation Targets to Understand the Mechanisms of Behavior Change and Improve Mood and Weight Outcomes
RAINBOW
Inclusion criteria:
- Ethnicity and race: Any;
- Obesity: BMI≥30 kg/m2 for non-Asians; BMI≥27 kg/m2 for Asians;
- Clinically significant depressive symptoms: PHQ-9≥10;
- A PAMF patient for ≥1 year
- Seen in primary care at least once in the preceding 24 months;
- Able and willing to enroll and meet the requirements of the study
Exclusion criteria:
- Inability to speak, read or understand English;
- Having no reliable telephone service, no device to use to watch a DVD, or no regular
Internet access via a computer and/or mobile device;
- Had bariatric surgery within the past 12 months or plans to undergo bariatric surgery
during the 24-month study period;
- Ongoing psychiatric care outside of the PAMF network.
- Active suicidal ideation that includes active plan and/or intent;
- 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 12 months (however Binge Eating Disorder
without purging is not an exclusionary condition);
- Active alcohol or substance use disorder (including prescription drugs).
- Pre-existing diabetes (other than during pregnancy) or diabetes diagnosed as a result
of fasting blood glucose or hemoglobin A1c levels obtained through study screening;
- Pre-existing cardiovascular disease.
- Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or
treated with radiation or chemotherapy within the past 12 months;
- Severe medical comorbidities that require aggressive treatment, e.g., stage 4 or
greater renal disease, liver failure;
- Diagnosis of a terminal illness and/or in hospice care;
- Residence in long-term care facility;
- Cognitive impairment based on the Callahan 6-item scale
- Plan to move out of the area or transfer care outside PAMF during the study period;
- Investigator discretion for reasons of clinical safety or protocol adherence.
ENGAGE
Inclusion criteria:
• RAINBOW participant
Exclusion criteria:
- Weight over 350 pounds
- MRI is contraindicated
- Traumatic brain injury
behavioral: RAINBOW Intervention Program
Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305