Research Aimed at Improving Both Mood and Weight

Not Applicable

Completed

Conditions: Depression
Obesity

Interventions: Behavioral: RAINBOW Intervention Program

Registration Number: NCT02246413

Lead Sponsor: Palo Alto Medical Foundation

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 409

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RAINBOW Intervention Program	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.

Primary Outcome Measures

Name	Time	Method
Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) Score	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.
Co-Primary Outcome: Body Mass Index (BMI)	12 months	Integrated intervention treatment response

Secondary Outcome Measures

Name	Time	Method
Anxiety (GAD-7)	24 months	Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms).
Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)	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.
Sleep Disturbance T-score	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	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.
Total Calorie Intake	One day's 24-hour dietary recall was administered at 12 months	Total calorie intake was measured using 24-hour dietary recalls and provides total energy intake.
Body Mass Index	24 months	Derived from height and weight measurements
Weight	24 months	Weight measurements
Depression Remission (Number of Participants With SCL-20 Scores <0.5)	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)	24 months	Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores \<0.5
Leisure Time Physical Activity	7-day Physical Activity Recall was administered at 12 months	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.
Total Energy Expenditure	7-day Physical Activity Recall was administered at 12 months	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).
Depression Symptom Checklist 20 (SCL-20) Score	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.
Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )	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) )	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)	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.
Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)	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)	24 months	5% or greater weight loss from baseline
Cost-effectiveness	12 months	Average annual per person spending on medical care services (2018 real US dollars)
Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)	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-Activity)	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)	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-Mobility)	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.
Change in Activation of Left Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion)	Baseline, 2 months	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.
Change in Activation of Right Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion)	Baseline, 2 months	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.
Utility-based Health-related Quality of Life (EQ-5D-Self-care)	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.
DASH (Dietary Approach to Stop Hypertension) Score	One day's 24-hour dietary recall was administered at 12 months	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