Research Aimed at Improving Both Mood and Weight

Obesity Clinical Trial

— RAINBOW-ENGAGE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246413
• Other study ID #: 14-05-323
• Secondary ID: R01HL119453UH2HL
• Status: Completed
• Phase: N/A
• Start date: September 30, 2014
• Est. completion date: December 21, 2018

Study information

• Verified date: September 2022
• Source: Palo Alto Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: December 21, 2018
• Est. primary completion date: January 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Obesity

Intervention

Behavioral:
• RAINBOW Intervention Program
Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care

Locations

Country	Name	City	State
United States	Palo Alto Medical Foundation	Palo Alto	California
United States	Stanford University	Stanford	California

Sponsors (7)

Lead Sponsor	Collaborator
Palo Alto Medical Foundation	National Heart, Lung, and Blood Institute (NHLBI), Stanford University, Sutter Health, University of Illinois at Chicago, University of Pittsburgh, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Co-Primary Outcome: Body Mass Index (BMI)	Integrated intervention treatment response	12 months
Primary	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.	12 months
Secondary	Body Mass Index	Derived from height and weight measurements	24 months
Secondary	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.	24 months
Secondary	Weight	Weight measurements	12 months
Secondary	Weight	Weight measurements	24 months
Secondary	Depression Remission (Number of Participants With SCL-20 Scores <0.5)	Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores <0.5	12 months
Secondary	Depression Remission (Number of Participants With SCL-20 Score <0.5)	Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores <0.5	24 months
Secondary	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	12 months
Secondary	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	24 months
Secondary	Clinically Significant Weight Loss (Number of Participants With =5% Weight Loss From Baseline)	5% or greater weight loss from baseline	12 months
Secondary	Clinically Significant Weight Loss (Number of Participants With =5% Weight Loss From Baseline)	5% or greater weight loss from baseline	24 months
Secondary	Cost-effectiveness	Average annual per person spending on medical care services (2018 real US dollars)	12 months
Secondary	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.	12 months
Secondary	Anxiety (GAD-7)	Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms).	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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 signi?cant functional impairment.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	Regulation of Cognition	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.	Baseline, 2, 6, 12, and 24 months
Secondary	Regulation of Self-reflection	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.	Baseline, 2, 6, 12, and 24 months
Secondary	Regulation of Emotion	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.	Baseline, 2, 6, 12, and 24 months
Secondary	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.	24 months
Secondary	Anxiety (GAD-7)	Self-administered questionnaire. Total scores of the 7 items with a range from 0 (no symptoms) to 21 (most severe symptoms).	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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 signi?cant functional impairment.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	24 months
Secondary	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.	7-day Physical Activity Recall was administered at 12 months
Secondary	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).	7-day Physical Activity Recall was administered at 12 months
Secondary	Total Calorie Intake	Total calorie intake was measured using 24-hour dietary recalls and provides total energy intake.	One day's 24-hour dietary recall was administered at 12 months
Secondary	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	One day's 24-hour dietary recall was administered at 12 months