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

• ClinicalTrials.gov Identifier: NCT02246413
• Recruitment Status: Completed
• First Posted: September 22, 2014
• Last Update Posted: March 27, 2019
• 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; Sutter Health
• Information provided by (Responsible Party): Jun Ma, MD, PhD, University of Illinois at Chicago

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Depression; Obesity	Behavioral: RAINBOW Intervention Program	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 409 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: 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
• Actual Study Start Date: November 5, 2014
• Actual Primary Completion Date: December 21, 2018
• Actual Study Completion Date: December 21, 2018

Arms and Interventions

Arm	Intervention/treatment
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.	Behavioral: RAINBOW Intervention Program; Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care
No Intervention: Usual Care; Usual Care.

Outcome Measures

Primary Outcome Measures :

1. Co-Primary Outcome: Body Mass Index (BMI) [ Time Frame: 12 months ]
   Integrated intervention treatment response
2. Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) score [ Time Frame: 12 months ]
   SCL-20 questionnaire

Secondary Outcome Measures :

1. Depression Symptom Checklist 20 (SCL-20) score [ Time Frame: 6, 18 and 24 months ]
   SCL-20 full questionnaire
2. Depression Symptom Checklist 20 (SCL-20) score [ Time Frame: 6, 12, 18 and 24 months ]
   Depression treatment response defined by 50% decline in SCL-20 symptom scores
3. Depression Symptom Checklist 20 (SCL-20) score [ Time Frame: 6, 12, 18 and 24 months ]
   Depression remission defined by SCL-20 symptom scores <0.5
4. Body Mass Index [ Time Frame: 6, 18 and 24 months ]
   Derived from height and weight measurements
5. Weight [ Time Frame: 6, 12, 18 and 24 months ]
   Weight measurements
6. Clinically significant weight loss [ Time Frame: 6, 12, 18 and 24 months ]
   5% or greater weight loss from baseline
7. Obesity-related psychosocial functioning (Obesity-related Problem Scale) [ Time Frame: 6, 12, 18 and 24 months ]
   Obesity's impact on psychosocial functioning.
8. Presence of metabolic syndrome based on waist circumference, BP, FBG, TG, and HDL [ Time Frame: 6, 12, 18 and 24 months ]
   Composite measure
9. Anxiety (GAD-7) [ Time Frame: 6, 12, 18 and 24 months ]
   Self-administered questionnaire
10. Utility-based Health-related Quality of Life (EQ-5D-5L) [ Time Frame: 6, 12, 18 and 24 months ]
    Self-administered questionnaire
11. Generic Health-related Quality of Life (SF-8) [ Time Frame: 6, 12, 18 and 24 months ]
    Self-administered questionnaire
12. Cost-effectiveness [ Time Frame: 12 and 24-months ]
    Health care utilization and intervention costs
13. Disability (Sheehan Disability Scale) [ Time Frame: 6, 12, 18 and 24 months ]
    Self-administered questionnaire
14. 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.
15. 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.
16. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Palo Alto Medical Foundation

Palo Alto, California, United States, 94301

Stanford University

Stanford, California, United States, 94305

Sponsors and Collaborators

Palo Alto Medical Foundation

National Heart, Lung, and Blood Institute (NHLBI)

University of Washington

University of Pittsburgh

Stanford University

University of Illinois at Chicago

Sutter Health

Investigators

• Principal Investigator: Jun Ma, MD, PhD; University of Illinois at Chicago
• Principal Investigator: Leanne Williams, PhD; Stanford University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ma J, Rosas LG, Lv N, Xiao L, Snowden MB, Venditti EM, Lewis MA, Goldhaber-Fiebert JD, Lavori PW. Effect of Integrated Behavioral Weight Loss Treatment and Problem-Solving Therapy on Body Mass Index and Depressive Symptoms Among Patients With Obesity and Depression: The RAINBOW Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):869-879. doi: 10.1001/jama.2019.0557.

Ma J, Xiao L, Lv N, Rosas LG, Lewis MA, Goldhaber-Fiebert JD, Venditti EM, Snowden MB, Lesser L, Ward E. Profiles of sociodemographic, behavioral, clinical and psychosocial characteristics among primary care patients with comorbid obesity and depression. Prev Med Rep. 2017 Aug 5;8:42-50. doi: 10.1016/j.pmedr.2017.07.010. eCollection 2017 Dec.

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.

• Responsible Party: Jun Ma, MD, PhD, Professor, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT02246413 History of Changes
• Other Study ID Numbers: 14-05-323; R01HL119453 ( U.S. NIH Grant/Contract ); UH2HL132368 ( U.S. NIH Grant/Contract )
• First Posted: September 22, 2014
• Last Update Posted: March 27, 2019
• Last Verified: March 2019

Keywords provided by Jun Ma, MD, PhD, University of Illinois at Chicago:

BMI; Depressive symptoms; Integrated therapy; Cardiometabolic risk; Self-regulation; Behavior change; Precision medicine; Lifestyle

Additional relevant MeSH terms:

Obesity; Depression; Depressive Disorder; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms; Behavioral Symptoms; Mood Disorders; Mental Disorders