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NCT Number: NCT02246413

Research Aimed at Improving Both Mood and Weight

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Self-Control Signs and Symptoms Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palo Alto Medical Foundation, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RAINBOW Intervention Program

Behavioral

Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care

Primary outcomes

  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 outcomes

  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. Change in Activation of Left Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion)

    Time frame: 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.

  25. Change in Activation of Right Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion)

    Time frame: 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.

  26. 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.

  27. 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).

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. Leisure Time Physical Activity

    Time frame: 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.

  39. Total Energy Expenditure

    Time frame: 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).

  40. Total Calorie Intake

    Time frame: 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.

  41. DASH (Dietary Approach to Stop Hypertension) Score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Palo Alto Medical Foundation

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Stanford University
  • Sutter Health
  • University of Illinois at Chicago
  • University of Pittsburgh
  • University of Washington

Registry information

Official study 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

Acronym: RAINBOW-ENGAGE

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 22, 2014
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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