ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02246413
Recruitment Status : Active, not recruiting
First Posted : September 22, 2014
Last Update Posted : April 5, 2018
Sponsor:
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

September 17, 2014
September 22, 2014
April 5, 2018
September 2014
March 2019   (Final data collection date for primary outcome measure)
  • Co-Primary Outcome: Body Mass Index (BMI) [ Time Frame: 12 months ]
    Integrated intervention treatment response
  • Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) score [ Time Frame: 12 months ]
    SCL-20 questionnaire
Same as current
Complete list of historical versions of study NCT02246413 on ClinicalTrials.gov Archive Site
  • Depression Symptom Checklist 20 (SCL-20) score [ Time Frame: 24 months ]
    Depression treatment response and remission.
  • Obesity-related psychosocial functioning (Obesity-related Problem Scale) [ Time Frame: 12- and 24-months ]
    Obesity's impact on psychosocial functioning.
  • Presence of metabolic syndrome based on waist circumference, BP, FBG, TG, and HDL [ Time Frame: 12- and 24-months ]
    Composite measure
  • Anxiety (GAD-7) [ Time Frame: 12- and 24-months ]
    Self-administered questionnaire
  • Utility-based Health-related Quality of Life (EQ-5D-5L) [ Time Frame: 12- and 24-months ]
    Self-administered questionnaire
  • Cost-effectiveness [ Time Frame: 24-months ]
    Health care utilization
  • Body mass index [ Time Frame: 24 months ]
    Derived from height and weight measurements
  • Disability (Sheehan Disability Scale) [ Time Frame: 12 and 24 months ]
    Self-administered questionnaire
Same as current
  • Regulation of emotion [ Time Frame: Baseline, 2, 6, 12, and 24 months ]
    Regulation of emotion will be measured using lab-based fMRI, virtual reality assays, and passive sampling of actual life behaviors using a Smartphone application. To measure regulation of emotion, fMRI assays include activation and connectivity values for approximately 300 brain regions, various physiological measures (heart rate, skin conductance, respiration rate) recorded on participant while performing tasks in fMRI scanner, performance and reaction times on various emotional web-based tasks, and online questionnaires administered with REDCap (emotional regulation questionnaire, early life stress questionnaire, and emotional regulation ratings success and strategies). Virtual reality assays include negative and positive emotion regulation head movement and emotional ratings. Passive sampling assays include passive experience sampling of 188 variables (e.g., mood-related word usage histograms) and Fitbit steps using a Smartphone application.
  • Regulation of cognition [ Time Frame: Baseline, 2, 6, 12, and 24 months ]
    Regulation of cognition will be measured using lab-based fMRI, virtual reality assays, and passive sampling using a Smartphone application. To measure regulation of cognition, fMRI assays include activation and connectivity values for approximately 300 brain regions, various physiological measures (heart rate, skin conductance, respiration rate) recorded on participant while performing tasks in fMRI scanner, performance and reaction times on various cognitive control web-based tasks, and online questionnaires administered with REDCap (COPE Inventory for Cognitive Coping and Clutter Image Rating Scale). Virtual reality assays include cognitive control head movement, cognitive control score, and emotional ratings. Passive sampling assays include passive experience sampling of cognitive functions and Fitbit steps using a Smartphone application.
  • Regulation of self-reflection [ Time Frame: Baseline, 2, 6, 12, and 24 months ]
    Regulation of cognition will be measured using lab-based fMRI, virtual reality assays, and passive sampling using a Smartphone application. To measure regulation of self-reflection, fMRI assays include activation and connectivity values for approximately 300 brain regions, various physiological measures (heart rate, skin conductance, respiration rate) recorded on participant while performing tasks in fMRI scanner, and online questionnaires administered with REDCap (BRISC Questionnaire of Emotional Resilience and Self-efficacy). Virtual reality assays include baseline/mindfulness head movement and emotional ratings. Passive sampling assays include passive experience sampling of the GPS for resting periods and Fitbit steps using a Smartphone application.
Not Provided
 
Research Aimed at Improving Both Mood and Weight
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
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
  • Depression
  • Obesity
Behavioral: RAINBOW Intervention Program
Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care
  • Experimental: RAINBOW Intervention Program
    An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.
    Intervention: Behavioral: RAINBOW Intervention Program
  • No Intervention: Usual Care
    Usual Care.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
404
Same as current
March 2019
March 2019   (Final data collection date for primary outcome measure)

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.

ENGAGE

Inclusion criteria:

• RAINBOW participant

Exclusion criteria:

  • Weight over 350 pounds
  • MRI is contraindicated
  • Traumatic brain injury
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02246413
14-05-323
R01HL119453 ( U.S. NIH Grant/Contract )
UH2HL132368 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Jun Ma, MD, PhD, University of Illinois at Chicago
Palo Alto Medical Foundation
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Washington
  • University of Pittsburgh
  • Stanford University
  • University of Illinois at Chicago
Principal Investigator: Jun Ma, MD, PhD University of Illinois at Chicago
Principal Investigator: Lisa Goldman Rosas, PhD, MPH Stanford University
Principal Investigator: Leanne Williams, PhD Stanford University
Principal Investigator: Kristen M J Azar, RN, MSN, MPH Sutter Health Research, Development & Dissemination
Palo Alto Medical Foundation
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP