Research Aimed at Improving Both Mood and Weight

The large numbers of primary care patients affected by coexisting obesity and depression and
common risk factors for diabetes and heart disease underscore the urgency of developing
effective, accessible, and sustainable interventions that use an integrated, multicondition
care management approach. The RAINBOW trial will rigorously evaluate the clinical and cost
effectiveness and potential for "real-world" implementation of an innovative intervention
that integrates a behavioral weight loss program and a collaborative stepped care program for
depression, incorporates conventional clinic- and home-based modes of care delivery (e.g.,
office visits plus phone consults and take-home DVD), and leverages low-cost, wide-reach
health information technologies (e.g., Web, secure email, and mobile texting). Beginning Jan
11, 2016, at least 100 of newly enrolled trial participants will also be consented to undergo
additional assays evaluating neurobiological mechanisms of self-regulation, including
emotional regulation, cognitive control and self-reflection. Given its focus on transforming
primary care management of obesity and depression and common cardiometabolic risk factors to
evidence-based, patient-centered care, as well as the likely scalability of the proposed
intervention, the study has high potential for significant clinical and public health impact.
Furthermore, elucidating the neurobiological mechanisms of self-regulation will significantly
advance precision lifestyle medicine by enabling mechanism-targeted individualization of
treatment.

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