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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
409
Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care
Palo Alto Medical Foundation
Palo Alto, California, United States
Stanford University
Stanford, California, United States
Co-Primary Outcome: Body Mass Index (BMI)
Integrated intervention treatment response
Time frame: 12 months
Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) Score
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.
Time frame: 12 months
Body Mass Index
Derived from height and weight measurements
Time frame: 24 months
Depression Symptom Checklist 20 (SCL-20) Score
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.
Time frame: 24 months
Weight
Weight measurements
Time frame: 12 months
Weight
Weight measurements
Time frame: 24 months
Depression Remission (Number of Participants With SCL-20 Scores <0.5)
Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores \<0.5
Time frame: 12 months
Depression Remission (Number of Participants With SCL-20 Score <0.5)
Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores \<0.5
Time frame: 24 months
Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)
Depression treatment response defined by 50% decline in SCL-20 symptom scores
Time frame: 12 months
Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)
Depression treatment response defined by 50% decline in SCL-20 symptom scores
Time frame: 24 months
Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)
5% or greater weight loss from baseline
Time frame: 12 months
Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)
5% or greater weight loss from baseline
Time frame: 24 months
Cost-effectiveness
Average annual per person spending on medical care services (2018 real US dollars)
Time frame: 12 months
Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)
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.
Time frame: 12 months
Anxiety (GAD-7)
Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms).
Time frame: 12 months
Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )
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.
Time frame: 12 months
Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )
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.
Time frame: 12 months
Disability (Sheehan Disability Scale)
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.
Time frame: 12 months
Utility-based Health-related Quality of Life (EQ-5D-Activity)
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.
Time frame: 12 months
Utility-based Health-related Quality of Life (EQ-5D-Pain)
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.
Time frame: 12 months
Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)
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.
Time frame: 12 months
Utility-based Health-related Quality of Life (EQ-5D-Mobility)
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.
Time frame: 12 months
Utility-based Health-related Quality of Life (EQ-5D-Self-care)
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.
Time frame: 12 months
Sleep Disturbance T-score
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.
Time frame: 12 months
Sleep Impairment T-score
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.
Time frame: 12 months
Change in Activation of Left Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion)
Regulation of emotion, specially activation of the amygdala for nonconscious threat-related emotional reactivity, is assessed using fMRI. In the facial emotion viewing paradigm, facial expression stimuli are standardized black and white photographs of 8 identities (4 female, 4 male) with evoked expressions of threat-related emotions (fear, anger), sad-related emotions (sadness) and reward-related emotions (happiness), along with neutral. To assess amygdala activation for the negative affect circuit, our analysis focused on threatening faces only. Threat stimuli included a combination of fear and anger stimuli relative to neutral blocks. A hemodynamic response convolved boxcar function was used to model the BOLD response for each block of emotional expressions to threat and to sadness relative to neutral face blocks. General linear models were then specified for each task to investigate the contrasts of interest. Higher beta-weight indicates higher activation of the amygdala.
Time frame: Baseline, 2 months
Change in Activation of Right Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion)
Regulation of emotion, specially activation of the amygdala for nonconscious threat-related emotional reactivity, is assessed using fMRI. In the facial emotion viewing paradigm, facial expression stimuli are standardized black and white photographs of 8 identities (4 female, 4 male) with evoked expressions of threat-related emotions (fear, anger), sad-related emotions (sadness) and reward-related emotions (happiness), along with neutral. To assess amygdala activation for the negative affect circuit, our analysis focused on threatening faces only. Threat stimuli included a combination of fear and anger stimuli relative to neutral blocks. A hemodynamic response convolved boxcar function was used to model the BOLD response for each block of emotional expressions to threat and to sadness relative to neutral face blocks. General linear models were then specified for each task to investigate the contrasts of interest. Higher beta-weight indicates higher activation of the amygdala.
Time frame: Baseline, 2 months
Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)
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.
Time frame: 24 months
Anxiety (GAD-7)
Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms).
Time frame: 24 months
Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )
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.
Time frame: 24 months
Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )
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.
Time frame: 24 months
Disability (Sheehan Disability Scale)
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.
Time frame: 24 months
Utility-based Health-related Quality of Life (EQ-5D-Activity)
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.
Time frame: 24 months
Utility-based Health-related Quality of Life (EQ-5D-Pain)
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.
Time frame: 24 months
Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)
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.
Time frame: 24 months
Utility-based Health-related Quality of Life (EQ-5D-Mobility)
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.
Time frame: 24 months
Utility-based Health-related Quality of Life (EQ-5D-Self-care)
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.
Time frame: 24 months
Sleep Disturbance T-score
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.
Time frame: 24 months
Sleep Impairment T-score
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.
Time frame: 24 months
Leisure Time Physical Activity
Physical activity was assessed as metabolic equivalent task (MET) minutes per week of leisure-time physical activity of at least moderate intensity based on the sum of the weighted physical activity minutes for moderate (weight: 4 METs), hard (weight: 6 METs), and very hard (weight: 10 METs) activities from the 7-day Physical Activity Recall.
Time frame: 7-day Physical Activity Recall was administered at 12 months
Total Energy Expenditure
Totally energy expenditure was measured using the 7-day Physical Activity Recall and provides estimates of total daily energy expenditures (total energy expenditure = sleep hours × 1 MET + light activity hours × 1.5 METs + moderate activity hours × 4 METs + hard activity hours × 6 METs + very hard activity hours × 10 METs).
Time frame: 7-day Physical Activity Recall was administered at 12 months
Total Calorie Intake
Total calorie intake was measured using 24-hour dietary recalls and provides total energy intake.
Time frame: One day's 24-hour dietary recall was administered at 12 months
DASH (Dietary Approach to Stop Hypertension) Score
Using 24-hour diet recalls, DASH scores were calculated based on combining nine nutrient targets (i.e. total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium and potassium). The intermediate target of each nutrient was half-way between the DASH target and population mean (based on the National Health and Nutrition Examination Surveys 2007-2008, latest data available at the inception of the study). For a nutrient, participants reaching the DASH target were assigned one point, those reaching the intermediate target were assigned a half-point, and those not meeting the intermediate target were given 0 points. The DASH score was the sum of points for all nine nutrients and ranged from 0 to 9. DASH score is a measure of diet quality, with higher score indicating higher diet quality
Time frame: One day's 24-hour dietary recall was administered at 12 months
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