DepressionRAINBOW-ENGAGENCT02246413
Research Aimed at Improving Both Mood and Weight
A study testing RAINBOW Intervention Program in people with Depression and Obesity, run by Palo Alto Medical Foundation at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Obesity
- What is being tested?
- RAINBOW Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2014to 21 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- RAINBOW participant
Who cannot join
- 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;
Show all 21Show fewer
- 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
- Weight over 350 pounds
- MRI is contraindicated
- Traumatic brain injury
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Palo Alto Medical Foundation
Palo Alto, California, 94301
Stanford University
Stanford, California, 94305
About this study
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
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.
Read the 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.
- Conditions
- Depression, Obesity
- Being tested
- RAINBOW Intervention Program
- Keywords
- BMI, Depressive symptoms, Integrated therapy, Cardiometabolic risk, Self-regulation, Behavior change, Precision medicine, Lifestyle
- Medical subject headings
- Depression, Obesity, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAINBOW Intervention ProgramBehavioural
Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care
| Study group | Role | What they receive |
|---|---|---|
| RAINBOW Intervention Program | Experimental | An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease. Receives: Behavioral: RAINBOW Intervention Program |
| Usual Care | No intervention | Usual Care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-Primary Outcome: Body Mass Index (BMI)
Integrated intervention treatment response
Measured: 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.
Measured: 12 months
Secondary outcomes (41)
Body Mass Index
Derived from height and weight measurements
Measured: 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.
Measured: 24 months
Weight
Weight measurements
Measured: 12 months
Weight
Weight measurements
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 months
Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)
5% or greater weight loss from baseline
Measured: 12 months
Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)
5% or greater weight loss from baseline
Measured: 24 months
Cost-effectiveness
Average annual per person spending on medical care services (2018 real US dollars)
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: One day's 24-hour dietary recall was administered at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study start30 Sep 2014
- Primary completion17 Jan 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Washington, University of Pittsburgh, Stanford University, University of Illinois Chicago, Sutter Health
- Responsible party
- Principal investigator, Jun Ma, MD, PhD, University of Illinois Chicago
- Investigators
- Jun Ma, MD, PhD, Principal investigator, University of Illinois ChicagoLeanne Williams, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246413
- Sponsor's protocol ID
- 14-05-323
- Other IDs
- R01HL119453, UH2HL132368
- Acronym
- RAINBOW-ENGAGE
- Status last verified
- Apr 2024
- First submitted
- 17 Sep 2014
- Last updated
- 26 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lv N, Chin SW, Xiao L, Tang Z, Parikh A, Ma J. Sex moderates diet quality differences in integrated collaborative care for comorbid obesity and depression: Post-hoc analysis of the RAINBOW RCT. J Nutr Health Aging. 2025 Jan;29(1):100426. doi: 10.1016/j.jnha.2024.100426. Epub 2024 Nov 29.
PubMed 39615398Zhang X, Pines A, Stetz P, Goldstein-Piekarski AN, Xiao L, Lv N, Tozzi L, Lavori PW, Snowden MB, Venditti EM, Smyth JM, Suppes T, Ajilore O, Ma J, Williams LM. Adaptive cognitive control circuit changes associated with problem-solving ability and depression symptom outcomes over 24 months. Sci Transl Med. 2024 Sep 4;16(763):eadh3172. doi: 10.1126/scitranslmed.adh3172. Epub 2024 Sep 4.
PubMed 39231241Kannampallil T, Dai R, Lv N, Xiao L, Lu C, Ajilore OA, Snowden MB, Venditti EM, Williams LM, Kringle EA, Ma J. Cross-trial prediction of depression remission using problem-solving therapy: A machine learning approach. J Affect Disord. 2022 Jul 1;308:89-97. doi: 10.1016/j.jad.2022.04.015. Epub 2022 Apr 7.
PubMed 35398399Lv N, Lefferts WK, Xiao L, Goldstein-Piekarski AN, Wielgosz J, Lavori PW, Simmons JM, Smyth JM, Stetz P, Venditti EM, Lewis MA, Rosas LG, Snowden MB, Ajilore OA, Suppes T, Williams LM, Ma J. Problem-solving therapy-induced amygdala engagement mediates lifestyle behavior change in obesity with comorbid depression: a randomized proof-of-mechanism trial. Am J Clin Nutr. 2021 Dec 1;114(6):2060-2073. doi: 10.1093/ajcn/nqab280.
PubMed 34476464Goldstein-Piekarski AN, Wielgosz J, Xiao L, Stetz P, Correa CG, Chang SE, Lv N, Rosas LG, Lavori PW, Snowden MB, Venditti EM, Simmons JM, Smyth JM, Suppes T, Lewis MA, Ajilore O, Ma J, Williams LM. Early changes in neural circuit function engaged by negative emotion and modified by behavioural intervention are associated with depression and problem-solving outcomes: A report from the ENGAGE randomized controlled trial. EBioMedicine. 2021 May;67:103387. doi: 10.1016/j.ebiom.2021.103387. Epub 2021 May 17.
PubMed 34004422Lv N, Xiao L, Rosas LG, Venditti EM, Smyth JM, Lewis MA, Snowden MB, Ronneberg CR, Williams LM, Gerber BS, Ajilore OA, Patel AS, Ma J. Sex Moderates Treatment Effects of Integrated Collaborative Care for Comorbid Obesity and Depression: The RAINBOW RCT. Ann Behav Med. 2021 Nov 18;55(12):1157-1167. doi: 10.1093/abm/kaaa125.
PubMed 33616188Goldhaber-Fiebert JD, Prince L, Xiao L, Lv N, Rosas LG, Venditti EM, Lewis MA, Snowden MB, Ma J. First-Year Economic and Quality of Life Effects of the RAINBOW Intervention to Treat Comorbid Obesity and Depression. Obesity (Silver Spring). 2020 Jun;28(6):1031-1039. doi: 10.1002/oby.22805. Epub 2020 Apr 22.
PubMed 32320533Lv N, Xiao L, Majd M, Lavori PW, Smyth JM, Rosas LG, Venditti EM, Snowden MB, Lewis MA, Ward E, Lesser L, Williams LM, Azar KMJ, Ma J. Variability in engagement and progress in efficacious integrated collaborative care for primary care patients with obesity and depression: Within-treatment analysis in the RAINBOW trial. PLoS One. 2020 Apr 21;15(4):e0231743. doi: 10.1371/journal.pone.0231743. eCollection 2020.
PubMed 32315362Rosas LG, Azar KMJ, Lv N, Xiao L, Goldhaber-Fiebert JD, Snowden MB, Venditti EM, Lewis MM, Goldstein-Piekarski AN, Ma J. Effect of an Intervention for Obesity and Depression on Patient-Centered Outcomes: An RCT. Am J Prev Med. 2020 Apr;58(4):496-505. doi: 10.1016/j.amepre.2019.11.005. Epub 2020 Feb 14.
PubMed 32067873Ma J, Rosas LG, Lv N, Xiao L, Snowden MB, Venditti EM, Lewis MA, Goldhaber-Fiebert JD, Lavori PW. Effect of Integrated Behavioral Weight Loss Treatment and Problem-Solving Therapy on Body Mass Index and Depressive Symptoms Among Patients With Obesity and Depression: The RAINBOW Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):869-879. doi: 10.1001/jama.2019.0557.
PubMed 30835308Ma J, Xiao L, Lv N, Rosas LG, Lewis MA, Goldhaber-Fiebert JD, Venditti EM, Snowden MB, Lesser L, Ward E. Profiles of sociodemographic, behavioral, clinical and psychosocial characteristics among primary care patients with comorbid obesity and depression. Prev Med Rep. 2017 Aug 5;8:42-50. doi: 10.1016/j.pmedr.2017.07.010. eCollection 2017 Dec.
PubMed 28840096Ma J, Yank V, Lv N, Goldhaber-Fiebert JD, Lewis MA, Kramer MK, Snowden MB, Rosas LG, Xiao L, Blonstein AC. Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial. Contemp Clin Trials. 2015 Jul;43:260-78. doi: 10.1016/j.cct.2015.06.010. Epub 2015 Jun 19.
PubMed 26096714
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02246413
- Acronym / sponsor ID
- RAINBOW-ENGAGE / 14-05-323
- Conditions
- Depression, Obesity
- Keywords
- BMI, Depressive symptoms, Integrated therapy, Cardiometabolic risk, Self-regulation, Behavior change, Precision medicine, Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Palo Alto Medical FoundationUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Washington, University of Pittsburgh, Stanford University, University of Illinois Chicago, Sutter Health
- Study start
- 30 Sep 2014 (actual)
- Primary completion
- 17 Jan 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Posted 11 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAINBOW Intervention Program | Experimental | Behavioral: RAINBOW Intervention ProgramAn integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease. |
| Usual Care | No intervention | –Usual Care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAINBOW Intervention ProgramIntegrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care | Behavioural | RAINBOW Intervention Program |
Primary outcome
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.
41 secondary outcomes
Body Mass Index
Time frame: 24 months
Depression Symptom Checklist 20 (SCL-20) Score
Time frame: 24 months
Weight
Time frame: 12 months
Weight
Time frame: 24 months
Depression Remission (Number of Participants With SCL-20 Scores <0.5)
Time frame: 12 months
Depression Remission (Number of Participants With SCL-20 Score <0.5)
Time frame: 24 months
Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)
Time frame: 12 months
Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)
Time frame: 24 months
Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)
Time frame: 12 months
Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)
Time frame: 24 months
Cost-effectiveness
Time frame: 12 months
Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)
Time frame: 12 months
Anxiety (GAD-7)
Time frame: 12 months
Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )
Time frame: 12 months
Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )
Time frame: 12 months
Disability (Sheehan Disability Scale)
Time frame: 12 months
Utility-based Health-related Quality of Life (EQ-5D-Activity)
Time frame: 12 months
Utility-based Health-related Quality of Life (EQ-5D-Pain)
Time frame: 12 months
Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)
Time frame: 12 months
Utility-based Health-related Quality of Life (EQ-5D-Mobility)
Time frame: 12 months
Utility-based Health-related Quality of Life (EQ-5D-Self-care)
Time frame: 12 months
Sleep Disturbance T-score
Time frame: 12 months
Sleep Impairment T-score
Time frame: 12 months
Change in Activation of Left Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion)
Time frame: Baseline, 2 months
Change in Activation of Right Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion)
Time frame: Baseline, 2 months
Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)
Time frame: 24 months
Anxiety (GAD-7)
Time frame: 24 months
Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )
Time frame: 24 months
Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )
Time frame: 24 months
Disability (Sheehan Disability Scale)
Time frame: 24 months
Utility-based Health-related Quality of Life (EQ-5D-Activity)
Time frame: 24 months
Utility-based Health-related Quality of Life (EQ-5D-Pain)
Time frame: 24 months
Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)
Time frame: 24 months
Utility-based Health-related Quality of Life (EQ-5D-Mobility)
Time frame: 24 months
Utility-based Health-related Quality of Life (EQ-5D-Self-care)
Time frame: 24 months
Sleep Disturbance T-score
Time frame: 24 months
Sleep Impairment T-score
Time frame: 24 months
Leisure Time Physical Activity
Time frame: 7-day Physical Activity Recall was administered at 12 months
Total Energy Expenditure
Time frame: 7-day Physical Activity Recall was administered at 12 months
Total Calorie Intake
Time frame: One day's 24-hour dietary recall was administered at 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39615398Lv N, Chin SW, Xiao L, Tang Z, Parikh A, Ma J. Sex moderates diet quality differences in integrated collaborative care for comorbid obesity and depression: Post-hoc analysis of the RAINBOW RCT. J Nutr Health Aging. 2025 Jan;29(1):100426. doi: 10.1016/j.jnha.2024.100426. Epub 2024 Nov 29.
- Derived from this study: PubMed 39231241Zhang X, Pines A, Stetz P, Goldstein-Piekarski AN, Xiao L, Lv N, Tozzi L, Lavori PW, Snowden MB, Venditti EM, Smyth JM, Suppes T, Ajilore O, Ma J, Williams LM. Adaptive cognitive control circuit changes associated with problem-solving ability and depression symptom outcomes over 24 months. Sci Transl Med. 2024 Sep 4;16(763):eadh3172. doi: 10.1126/scitranslmed.adh3172. Epub 2024 Sep 4.
- Derived from this study: PubMed 35398399Kannampallil T, Dai R, Lv N, Xiao L, Lu C, Ajilore OA, Snowden MB, Venditti EM, Williams LM, Kringle EA, Ma J. Cross-trial prediction of depression remission using problem-solving therapy: A machine learning approach. J Affect Disord. 2022 Jul 1;308:89-97. doi: 10.1016/j.jad.2022.04.015. Epub 2022 Apr 7.
- Derived from this study: PubMed 34476464Lv N, Lefferts WK, Xiao L, Goldstein-Piekarski AN, Wielgosz J, Lavori PW, Simmons JM, Smyth JM, Stetz P, Venditti EM, Lewis MA, Rosas LG, Snowden MB, Ajilore OA, Suppes T, Williams LM, Ma J. Problem-solving therapy-induced amygdala engagement mediates lifestyle behavior change in obesity with comorbid depression: a randomized proof-of-mechanism trial. Am J Clin Nutr. 2021 Dec 1;114(6):2060-2073. doi: 10.1093/ajcn/nqab280.
- Derived from this study: PubMed 34004422Goldstein-Piekarski AN, Wielgosz J, Xiao L, Stetz P, Correa CG, Chang SE, Lv N, Rosas LG, Lavori PW, Snowden MB, Venditti EM, Simmons JM, Smyth JM, Suppes T, Lewis MA, Ajilore O, Ma J, Williams LM. Early changes in neural circuit function engaged by negative emotion and modified by behavioural intervention are associated with depression and problem-solving outcomes: A report from the ENGAGE randomized controlled trial. EBioMedicine. 2021 May;67:103387. doi: 10.1016/j.ebiom.2021.103387. Epub 2021 May 17.
- Derived from this study: PubMed 33616188Lv N, Xiao L, Rosas LG, Venditti EM, Smyth JM, Lewis MA, Snowden MB, Ronneberg CR, Williams LM, Gerber BS, Ajilore OA, Patel AS, Ma J. Sex Moderates Treatment Effects of Integrated Collaborative Care for Comorbid Obesity and Depression: The RAINBOW RCT. Ann Behav Med. 2021 Nov 18;55(12):1157-1167. doi: 10.1093/abm/kaaa125.
- Derived from this study: PubMed 32320533Goldhaber-Fiebert JD, Prince L, Xiao L, Lv N, Rosas LG, Venditti EM, Lewis MA, Snowden MB, Ma J. First-Year Economic and Quality of Life Effects of the RAINBOW Intervention to Treat Comorbid Obesity and Depression. Obesity (Silver Spring). 2020 Jun;28(6):1031-1039. doi: 10.1002/oby.22805. Epub 2020 Apr 22.
- Derived from this study: PubMed 32315362Lv N, Xiao L, Majd M, Lavori PW, Smyth JM, Rosas LG, Venditti EM, Snowden MB, Lewis MA, Ward E, Lesser L, Williams LM, Azar KMJ, Ma J. Variability in engagement and progress in efficacious integrated collaborative care for primary care patients with obesity and depression: Within-treatment analysis in the RAINBOW trial. PLoS One. 2020 Apr 21;15(4):e0231743. doi: 10.1371/journal.pone.0231743. eCollection 2020.
- Derived from this study: PubMed 32067873Rosas LG, Azar KMJ, Lv N, Xiao L, Goldhaber-Fiebert JD, Snowden MB, Venditti EM, Lewis MM, Goldstein-Piekarski AN, Ma J. Effect of an Intervention for Obesity and Depression on Patient-Centered Outcomes: An RCT. Am J Prev Med. 2020 Apr;58(4):496-505. doi: 10.1016/j.amepre.2019.11.005. Epub 2020 Feb 14.
- Derived from this study: PubMed 30835308Ma J, Rosas LG, Lv N, Xiao L, Snowden MB, Venditti EM, Lewis MA, Goldhaber-Fiebert JD, Lavori PW. Effect of Integrated Behavioral Weight Loss Treatment and Problem-Solving Therapy on Body Mass Index and Depressive Symptoms Among Patients With Obesity and Depression: The RAINBOW Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):869-879. doi: 10.1001/jama.2019.0557.
- Derived from this study: PubMed 28840096Ma J, Xiao L, Lv N, Rosas LG, Lewis MA, Goldhaber-Fiebert JD, Venditti EM, Snowden MB, Lesser L, Ward E. Profiles of sociodemographic, behavioral, clinical and psychosocial characteristics among primary care patients with comorbid obesity and depression. Prev Med Rep. 2017 Aug 5;8:42-50. doi: 10.1016/j.pmedr.2017.07.010. eCollection 2017 Dec.
- Derived from this study: PubMed 26096714Ma J, Yank V, Lv N, Goldhaber-Fiebert JD, Lewis MA, Kramer MK, Snowden MB, Rosas LG, Xiao L, Blonstein AC. Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial. Contemp Clin Trials. 2015 Jul;43:260-78. doi: 10.1016/j.cct.2015.06.010. Epub 2015 Jun 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Ma, MD, PhD principal investigator
University of Illinois Chicago
Leanne Williams, PhD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAINBOW Intervention Program in people with Depression and Obesity, run by Palo Alto Medical Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-Primary Outcome: Body Mass Index (BMI) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02246413, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.