Research Aimed at Improving Both Mood and Weight (RAINBOW-ENGAGE)

Sutter Health

Status

Completed

Conditions

Obesity

Depression

Treatments

Behavioral: RAINBOW Intervention Program

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02246413

R01HL119453 (U.S. NIH Grant/Contract)

14-05-323

UH2HL132368 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The RAINBOW study is an NIH R01-funded randomized controlled trial to evaluate the clinical and cost effectiveness and implementation potential of a primary care integrated multicondition intervention program to help improve mood and weight for obese adults with clinically significant depressive symptoms. The ENGAGE study is a mechanistic investigation added to the main trial with funding through the NIH common fund for the Science of Behavior Change roadmap initiative. Beginning Jan 11, 2016, at least 100 of newly enrolled trial participants will be consented to undergo additional assays evaluating neurobiological mechanisms of self-regulation.

Full description

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.

Enrollment

409 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.