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Contemp Clin Trials. 2015 Jul;43:260-78. doi: 10.1016/j.cct.2015.06.010. Epub 2015 Jun 19.

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

Author information

1
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.
2
Department of Medicine, Stanford University School of Medicine, Stanford, CA 94304, USA.
3
Palo Alto Medical Foundation Research Institute, Ames Building, 795 El Camino Real, Palo Alto, CA 94301, USA.
4
Stanford Health Policy, Centers for Health Policy and Primary Care and Outcomes Research, 117 Encina Commons, Stanford, CA 94305, USA.
5
RTI International, 3040 Cornwallis Road, Research Triangle Park, NC 27709, USA.
6
Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, 3512 Fifth Avenue, Pittsburgh, PA 15213, USA.
7
Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 325 Ninth Avenue, Seattle, WA 98104, USA.
8
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.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02246413.

KEYWORDS:

Depression; Lifestyle change; Obesity; Problem solving therapy; Randomized controlled trial; Standard behavioral treatment

PMID:
26096714
PMCID:
PMC4537656
DOI:
10.1016/j.cct.2015.06.010
[Indexed for MEDLINE]
Free PMC Article

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