title: Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial.
abstract: Effective interventions targeting comorbid obesity and depression are critical given the increasing prevalence and worsened outcomes for patients with both conditions. RAINBOW is a type 1 hybrid design randomized controlled trial. The objective is to evaluate the clinical and cost effectiveness and implementation potential of an integrated, technology-enhanced, collaborative care model for treating comorbid obesity and depression in primary care. Obese and depressed adults (n = 404) will be randomized to usual care enhanced with the provision of a pedometer and information about the health system's services for mood or weight management (control) or with the Integrated Coaching for Better Mood and Weight (I-CARE) program (intervention). The 12-month I-CARE program synergistically integrates two proven behavioral interventions: problem-solving therapy with as-needed intensification of pharmacotherapy for depression (PEARLS) and standardized behavioral treatment for obesity (Group Lifestyle Balance(™)). It utilizes traditional (e.g., office visits and phone consults) and emerging care delivery modalities (e.g., patient web portal and mobile applications). Follow-up assessments will occur at 6, 12, 18, and 24 months. We hypothesize that compared with controls, I-CARE participants will have greater improvements in weight and depression severity measured by the 20-item Depression Symptom Checklist at 12 months, which will be sustained at 24 months. We will also assess I-CARE's cost-effectiveness and use mixed methods to examine its potential for reach, adoption, implementation, and maintenance. This study offers the potential to change how obese and depressed adults are treated-through a new model of accessible and integrative lifestyle medicine and mental health expertise-in primary care.
authors.affiliation: Palo Alto Medical Foundation Research Institute, Ames Building, 795 El Camino Real, Palo Alto, CA 94301, USA; Department of Medicine, Stanford University School of Medicine, Stanford, CA 94304, USA. Electronic address: maj@pamfri.org.
authors.forename: Jun
authors.initials: J
authors.lastname: Ma
authors.affiliation: Department of Medicine, Stanford University School of Medicine, Stanford, CA 94304, USA.
authors.forename: Veronica
authors.initials: V
authors.lastname: Yank
authors.affiliation: Palo Alto Medical Foundation Research Institute, Ames Building, 795 El Camino Real, Palo Alto, CA 94301, USA.
authors.forename: Nan
authors.initials: N
authors.lastname: Lv
authors.affiliation: Stanford Health Policy, Centers for Health Policy and Primary Care and Outcomes Research, 117 Encina Commons, Stanford, CA 94305, USA.
authors.forename: Jeremy D
authors.initials: JD
authors.lastname: Goldhaber-Fiebert
authors.affiliation: RTI International, 3040 Cornwallis Road, Research Triangle Park, NC 27709, USA.
authors.forename: Megan A
authors.initials: MA
authors.lastname: Lewis
authors.affiliation: Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, 3512 Fifth Avenue, Pittsburgh, PA 15213, USA.
authors.forename: M Kaye
authors.initials: MK
authors.lastname: Kramer
authors.affiliation: Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Avenue, Seattle, WA 98104, USA.
authors.forename: Mark B
authors.initials: MB
authors.lastname: Snowden
authors.affiliation: Palo Alto Medical Foundation Research Institute, Ames Building, 795 El Camino Real, Palo Alto, CA 94301, USA; Department of Medicine, Stanford University School of Medicine, Stanford, CA 94304, USA.
authors.forename: Lisa G
authors.initials: LG
authors.lastname: Rosas
authors.affiliation: Palo Alto Medical Foundation Research Institute, Ames Building, 795 El Camino Real, Palo Alto, CA 94301, USA.
authors.forename: Lan
authors.initials: L
authors.lastname: Xiao
authors.affiliation: Palo Alto Medical Foundation Research Institute, Ames Building, 795 El Camino Real, Palo Alto, CA 94301, USA.
authors.forename: Andrea C
authors.initials: AC
authors.lastname: Blonstein
mesh_terms: D000339:Affect; D000367:Age Factors; D000928:Antidepressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001521:Behavior Therapy / Q000191:economics / Q000379:methods*; D015992:Body Mass Index; D001835:Body Weight; D003131:Combined Modality Therapy; D003362:Cost-Benefit Analysis; D003866:Depressive Disorder / Q000453:epidemiology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D009765:Obesity / Q000453:epidemiology / Q000628:therapy*; D011320:Primary Health Care / Q000458:organization & administration; D044469:Racial Groups; D012107:Research Design; D012737:Sex Factors; D012959:Socioeconomic Factors
chemical_list: D000928:Antidepressive Agents
keywords: Depression; Lifestyle change; Obesity; Problem solving therapy; Randomized controlled trial; Standard behavioral treatment