Research Aimed at Improving Both Mood and Weight (RAINBOW-ENGAGE)
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ClinicalTrials.gov Identifier: NCT02246413 |
Recruitment Status :
Completed
First Posted : September 22, 2014
Results First Posted : June 11, 2020
Last Update Posted : June 23, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depression Obesity | Behavioral: RAINBOW Intervention Program | Not Applicable |
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 |

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.
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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.
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- 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 ]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.
- Body Mass Index [ Time Frame: 24 months ]Derived from height and weight measurements
- 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.
- Weight [ Time Frame: 12 months ]Weight measurements
- Weight [ Time Frame: 24 months ]Weight measurements
- 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
- 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
- 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
- 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
- Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline) [ Time Frame: 12 months ]5% or greater weight loss from baseline
- Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline) [ Time Frame: 24 months ]5% or greater weight loss from baseline
- Cost-effectiveness [ Time Frame: 12 months ]Average annual per person spending on medical care services (2018 real US dollars)
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246413
United States, California | |
Palo Alto Medical Foundation | |
Palo Alto, California, United States, 94301 | |
Stanford University | |
Stanford, California, United States, 94305 |
Principal Investigator: | Jun Ma, MD, PhD | University of Illinois at Chicago | |
Principal Investigator: | Leanne Williams, PhD | Stanford University |
Documents provided by Jun Ma, MD, PhD, University of Illinois at Chicago:
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 Key Record Dates |
Results First Posted: | June 11, 2020 |
Last Update Posted: | June 23, 2020 |
Last Verified: | June 2020 |
BMI Depressive symptoms Integrated therapy Cardiometabolic risk |
Self-regulation Behavior change Precision medicine Lifestyle |
Obesity Depression Overnutrition Nutrition Disorders |
Overweight Body Weight Behavioral Symptoms |