• Contemp Clin Trials · Jul 2015

    Randomized Controlled Trial Multicenter Study

    Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial.

    • Jun Ma, Veronica Yank, Nan Lv, Jeremy D Goldhaber-Fiebert, Megan A Lewis, M Kaye Kramer, Mark B Snowden, Lisa G Rosas, Lan Xiao, and Andrea C Blonstein.
    • 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.
    • Contemp Clin Trials. 2015 Jul 1; 43: 260-78.

    AbstractEffective 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.Copyright © 2015 Elsevier Inc. All rights reserved.

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