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

• ClinicalTrials.gov Identifier: NCT02246413
• Recruitment Status: Completed
• First Posted: September 22, 2014
• Results First Posted: June 11, 2020
• Last Update Posted: June 23, 2020
• 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: September 30, 2014
• Actual Primary Completion Date: January 17, 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 ]
   Depression Symptom Checklist 20 (SCL-20) questionnaire score. SCL-20, average scores of the 20 items with a range from 0 (not at all) to 4 (extremely). SCL-20 cutoff points scores of ≤0.75, >0.75-1.5, >1.5- 2.0, and >2.0 represent remission, mild depression, moderate depression, and severe depression, respectively.

Secondary Outcome Measures :

1. Body Mass Index [ Time Frame: 24 months ]
   Derived from height and weight measurements
2. Depression Symptom Checklist 20 (SCL-20) Score [ Time Frame: 24 months ]
   SCL-20 full questionnaire. SCL-20, average scores of the 20 items with a range from 0 (not at all) to 4 (extremely). SCL-20 cutoff points scores of ≤0.75, >0.75-1.5, >1.5- 2.0, and >2.0 represent remission, mild depression, moderate depression, and severe depression, respectively.
3. Weight [ Time Frame: 12 months ]
   Weight measurements
4. Weight [ Time Frame: 24 months ]
   Weight measurements
5. Depression Remission (Number of Participants With SCL-20 Scores <0.5) [ Time Frame: 12 months ]
   Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores <0.5
6. Depression Remission (Number of Participants With SCL-20 Score <0.5) [ Time Frame: 24 months ]
   Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores <0.5
7. Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline) [ Time Frame: 12 months ]
   Depression treatment response defined by 50% decline in SCL-20 symptom scores
8. Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline) [ Time Frame: 24 months ]
   Depression treatment response defined by 50% decline in SCL-20 symptom scores
9. Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline) [ Time Frame: 12 months ]
   5% or greater weight loss from baseline
10. Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline) [ Time Frame: 24 months ]
    5% or greater weight loss from baseline
11. Cost-effectiveness [ Time Frame: 12 months ]
    Average annual per person spending on medical care services (2018 real US dollars)
12. Obesity-related Psychosocial Functioning (Obesity-related Problem Scale) [ Time Frame: 12 months ]
    Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems.
13. Anxiety (GAD-7) [ Time Frame: 12 months ]
    Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms).
14. Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) ) [ Time Frame: 12 months ]
    Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - physical component (PCS) ) Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.
15. Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ) [ Time Frame: 12 months ]
    Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.
16. Disability (Sheehan Disability Scale) [ Time Frame: 12 months ]
    Self-administered Sheehan Disability Scale questionnaire. Sheehan Disability Scale, total scores of the 3 items with a range from 0 (unimpaired) to 30 (highly impaired). Scores of ≥5 on any of the 3 scales (Work/school [0-10], Social life [0-10], and Family life/home responsibilities [0-10]) are associated with significant functional impairment.
17. Utility-based Health-related Quality of Life (EQ-5D-Activity) [ Time Frame: 12 months ]
    Self-administered questionnaire: Utility-based Health-related Quality of Life - USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities). A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
18. Utility-based Health-related Quality of Life (EQ-5D-Pain) [ Time Frame: 12 months ]
    Self-administered questionnaire: Utility-based Health-related Quality of Life - PAIN/DISCOMFORT. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
19. Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression) [ Time Frame: 12 months ]
    Self-administered questionnaire: Utility-based Health-related Quality of Life - Anxiety and depression. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
20. Utility-based Health-related Quality of Life (EQ-5D-Mobility) [ Time Frame: 12 months ]
    Self-administered questionnaire: Utility-based Health-related Quality of Life - Mobility. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
21. Utility-based Health-related Quality of Life (EQ-5D-Self-care) [ Time Frame: 12 months ]
    Self-administered questionnaire: Utility-based Health-related Quality of Life - Self-care. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
22. Sleep Disturbance T-score [ Time Frame: 12 months ]
    Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.
23. Sleep Impairment T-score [ Time Frame: 12 months ]
    Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.
24. Regulation of Cognition [ Time Frame: Baseline, 2, 6, 12, and 24 months ]
    Regulation of cognition is measured using lab-based fMRI. 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). Data analysis is ongoing because it involves complex imaging fMRI data processing and analyzing.
25. Regulation of Self-reflection [ Time Frame: Baseline, 2, 6, 12, and 24 months ]
    Regulation of cognition is measured using lab-based fMRI. 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). Data analysis is ongoing because it involves complex imaging fMRI data processing and analyzing.
26. Regulation of Emotion [ Time Frame: Baseline, 2, 6, 12, and 24 months ]
    Regulation of emotion is measured using lab-based fMRI. 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). Data analysis is ongoing because it involves complex imaging fMRI data processing and analyzing.
27. Obesity-related Psychosocial Functioning (Obesity-related Problem Scale) [ Time Frame: 24 months ]
    Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems.
28. Anxiety (GAD-7) [ Time Frame: 24 months ]
    Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms).
29. Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) ) [ Time Frame: 24 months ]
    Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - physical component (PCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.
30. Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ) [ Time Frame: 24 months ]
    Self-administered questionnaire - Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) ). Physical and mental composite scores, a population scale ranged from 0 (lowest quality of life) to 100 (highest quality of life) summed by the total converted scores of each value of the 8 questions. These summary scales have been normalized in the U.S. population (value=50). The higher score indicates better self-reported health-related quality of life.
31. Disability (Sheehan Disability Scale) [ Time Frame: 24 months ]
    Self-administered Sheehan Disability Scale questionnaire. Sheehan Disability Scale, total scores of the 3 items with a range from 0 (unimpaired) to 30 (highly impaired). Scores of ≥5 on any of the 3 scales (Work/school [0-10], Social life [0-10], and Family life/home responsibilities [0-10]) are associated with significant functional impairment.
32. Utility-based Health-related Quality of Life (EQ-5D-Activity) [ Time Frame: 24 months ]
    Self-administered questionnaire: Utility-based Health-related Quality of Life - USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities). A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
33. Utility-based Health-related Quality of Life (EQ-5D-Pain) [ Time Frame: 24 months ]
    Self-administered questionnaire: Utility-based Health-related Quality of Life - PAIN/DISCOMFORT. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
34. Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression) [ Time Frame: 24 months ]
    Self-administered questionnaire: Utility-based Health-related Quality of Life - Anxiety and depression. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
35. Utility-based Health-related Quality of Life (EQ-5D-Mobility) [ Time Frame: 24 months ]
    Self-administered questionnaire: Utility-based Health-related Quality of Life - Mobility. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
36. Utility-based Health-related Quality of Life (EQ-5D-Self-care) [ Time Frame: 24 months ]
    Self-administered questionnaire: Utility-based Health-related Quality of Life - Self-care. A 5-point scale (1) No problems, (2) Slight problems, (3) Moderate problems, (4) Severe problems, and (5) Extreme problems.
37. Sleep Disturbance T-score [ Time Frame: 24 months ]
    Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.
38. Sleep Impairment T-score [ Time Frame: 24 months ]
    Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness.

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

  Study Documents (Full-Text)

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

Study Protocol and Statistical Analysis Plan  [PDF] July 1, 2016

More Information

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

Lv N, Xiao L, Rosas LG, Venditti EM, Smyth JM, Lewis MA, Snowden MB, Ronneberg CR, Williams LM, Gerber BS, Ajilore OA, Patel AS, Ma J. Sex Moderates Treatment Effects of Integrated Collaborative Care for Comorbid Obesity and Depression: The RAINBOW RCT. Ann Behav Med. 2021 Feb 22. pii: kaaa125. doi: 10.1093/abm/kaaa125. [Epub ahead of print]

Goldhaber-Fiebert JD, Prince L, Xiao L, Lv N, Rosas LG, Venditti EM, Lewis MA, Snowden MB, Ma J. First-Year Economic and Quality of Life Effects of the RAINBOW Intervention to Treat Comorbid Obesity and Depression. Obesity (Silver Spring). 2020 Jun;28(6):1031-1039. doi: 10.1002/oby.22805. Epub 2020 Apr 22.

Lv N, Xiao L, Majd M, Lavori PW, Smyth JM, Rosas LG, Venditti EM, Snowden MB, Lewis MA, Ward E, Lesser L, Williams LM, Azar KMJ, Ma J. Variability in engagement and progress in efficacious integrated collaborative care for primary care patients with obesity and depression: Within-treatment analysis in the RAINBOW trial. PLoS One. 2020 Apr 21;15(4):e0231743. doi: 10.1371/journal.pone.0231743. eCollection 2020. Erratum in: PLoS One. 2020 Aug 21;15(8):e0238276.

Rosas LG, Azar KMJ, Lv N, Xiao L, Goldhaber-Fiebert JD, Snowden MB, Venditti EM, Lewis MM, Goldstein-Piekarski AN, Ma J. Effect of an Intervention for Obesity and Depression on Patient-Centered Outcomes: An RCT. Am J Prev Med. 2020 Apr;58(4):496-505. doi: 10.1016/j.amepre.2019.11.005. Epub 2020 Feb 14.

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
• Other Study ID Numbers: 14-05-323; R01HL119453 ( U.S. NIH Grant/Contract ); UH2HL132368 ( U.S. NIH Grant/Contract )
• First Posted: September 22, 2014
• Results First Posted: June 11, 2020
• Last Update Posted: June 23, 2020
• Last Verified: June 2020

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; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Behavioral Symptoms