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Research Aimed at Improving Both Mood and Weight (RAINBOW-ENGAGE)
This study is ongoing, but not recruiting participants.
Sponsor:
Palo Alto Medical Foundation
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of Washington
University of Pittsburgh
Stanford University
University of Illinois at Chicago
Information provided by (Responsible Party):
Jun Ma, MD, PhD, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT02246413
First received: September 17, 2014
Last updated: February 15, 2017
Last verified: February 2017
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| First Received Date ICMJE | September 17, 2014 | |||||||||
| Last Updated Date | February 15, 2017 | |||||||||
| Start Date ICMJE | September 2014 | |||||||||
| Estimated Primary Completion Date | March 2019 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | Complete list of historical versions of study NCT02246413 on ClinicalTrials.gov Archive Site | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Outcome Measures ICMJE |
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| Original Other Outcome Measures ICMJE | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Research Aimed at Improving Both Mood and Weight | |||||||||
| Official Title ICMJE | RCT on Co-management of Obesity, Depression, and Elevated CVD Risk in Primary Care-- Engaging Self-regulation Targets to Understand the Mechanisms of Behavior Change and Improve Mood and Weight Outcomes | |||||||||
| Brief Summary | 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. | |||||||||
| Detailed 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. | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase | Not Provided | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Investigator, Outcomes Assessor Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: RAINBOW Intervention Program
Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care |
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| Study Arms |
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| Publications * | Ma J, Yank V, Lv N, Goldhaber-Fiebert JD, Lewis MA, Kramer MK, Snowden MB, Rosas LG, Xiao L, Blonstein AC. Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial. Contemp Clin Trials. 2015 Jul;43:260-78. doi: 10.1016/j.cct.2015.06.010. Epub 2015 Jun 19. | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Active, not recruiting | |||||||||
| Estimated Enrollment ICMJE | 404 | |||||||||
| Estimated Completion Date | March 2019 | |||||||||
| Estimated Primary Completion Date | March 2019 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | RAINBOW Inclusion criteria:
Exclusion criteria:
ENGAGE Inclusion criteria: • RAINBOW participant Exclusion criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT02246413 | |||||||||
| Other Study ID Numbers ICMJE | 14-05-323 R01HL119453 ( U.S. NIH Grant/Contract ) UH2HL132368 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | Jun Ma, MD, PhD, University of Illinois at Chicago | |||||||||
| Study Sponsor ICMJE | Palo Alto Medical Foundation | |||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Palo Alto Medical Foundation | |||||||||
| Verification Date | February 2017 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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