NCT02246413: RAINBOW-ENGAGE

Research Aimed at Improving Both Mood and Weight

Completed NA Results posted Last updated 26 April 2024

What this trial tests

NA trial testing RAINBOW Intervention Program in Depression in 409 participants. Completed in 21 December 2018.

Timeline

30 September 2014

Primary endpoint
17 January 2018

21 December 2018

Quick facts

Lead sponsor	Palo Alto Medical Foundation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	409
Start date	30 September 2014
Primary completion	17 January 2018
Estimated completion	21 December 2018
Sites	2 locations across United States

Drugs / interventions tested

• RAINBOW Intervention Program

Conditions studied

• Depression — all drugs for Depression →
• Obesity — all drugs for Obesity →

Sponsor

Palo Alto Medical Foundation

Who can join

18 and older, any sex, with Depression or Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Co-Primary Outcome: Body Mass Index (BMI) Primary · 12 months

Integrated intervention treatment response

Group	Value	95% CI
RAINBOW Intervention Program	35.9	± 7.1
Usual Care	36.6	± 6.0

Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) Score Primary · 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.

Group	Value	95% CI
RAINBOW Intervention Program	1.1	± 0.7
Usual Care	1.4	± 0.9

Body Mass Index Secondary · 24 months

Derived from height and weight measurements

Group	Value	95% CI
RAINBOW Intervention Program	36.2	± 7.3
Usual Care	36.2	± 6.5

Depression Symptom Checklist 20 (SCL-20) Score Secondary · 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.

Group	Value	95% CI
RAINBOW Intervention Program	1.3	± 0.8
Usual Care	1.4	± 0.9

Weight Secondary · 12 months

Weight measurements

Group	Value	95% CI
RAINBOW Intervention Program	100.8	± 22.8
Usual Care	103.4	± 20.9

Weight Secondary · 24 months

Weight measurements

Group	Value	95% CI
RAINBOW Intervention Program	101.8	± 24
Usual Care	102.4	± 22.4

Depression Remission (Number of Participants With SCL-20 Scores <0.5) Secondary · 12 months

Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores \<0.5

Group	Value	95% CI
RAINBOW Intervention Program	30
Usual Care	23

Depression Remission (Number of Participants With SCL-20 Score <0.5) Secondary · 24 months

Depression remission defined by Depression Symptom Checklist 20 (SCL-20) scores \<0.5

Group	Value	95% CI
RAINBOW Intervention Program	31
Usual Care	20

Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline) Secondary · 12 months

Depression treatment response defined by 50% decline in SCL-20 symptom scores

Group	Value	95% CI
RAINBOW Intervention Program	49
Usual Care	38

Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline) Secondary · 24 months

Depression treatment response defined by 50% decline in SCL-20 symptom scores

Group	Value	95% CI
RAINBOW Intervention Program	40
Usual Care	39

Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline) Secondary · 12 months

5% or greater weight loss from baseline

Group	Value	95% CI
RAINBOW Intervention Program	51
Usual Care	27

Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline) Secondary · 24 months

5% or greater weight loss from baseline

Group	Value	95% CI
RAINBOW Intervention Program	42
Usual Care	37

Adverse events — posted to ClinicalTrials.gov

Time frame: Primary and secondary outcome period (up to 24-months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RAINBOW Intervention Program

Serious: 17/204 (8%)

Deaths: 0/204

Usual Care

Serious: 19/205 (9%)

Deaths: 0/205

Serious adverse events (10 terms)

Reaction	System	RAINBOW Intervention Program	Usual Care
Musculoskeletal problems	Musculoskeletal and connective tissue disorders	—	—
Digestive system problem	Gastrointestinal disorders	—	—
Cardiac problems	Cardiac disorders	—	—
Lymphoma diagnosis	Blood and lymphatic system disorders	—	—
Psychiatric problems	Psychiatric disorders	—	—
Reproductive system problems	Reproductive system and breast disorders	—	—
Diabetes diagnosis	Endocrine disorders	—	—
Nervous system problem	Nervous system disorders	—	—
Skin problem	Skin and subcutaneous tissue disorders	—	—
Cataract surgery	General disorders	—	—

Other adverse events (14 terms — click to expand)

Reaction	System	RAINBOW Intervention Program	Usual Care
Musculoskeletal problems	Musculoskeletal and connective tissue disorders	—	—
Respiratory problem	Respiratory, thoracic and mediastinal disorders	—	—
Digestive system problem	Gastrointestinal disorders	—	—
Skin problems	Skin and subcutaneous tissue disorders	—	—
Nervous system problem	Nervous system disorders	—	—
Cardiac problems	Cardiac disorders	—	—
Lymphatic problems	Blood and lymphatic system disorders	—	—
Reproductive system problems	Reproductive system and breast disorders	—	—
Endocrine problems	Endocrine disorders	—	—
Psychiatric problem	Psychiatric disorders	—	—
Vascular problems	Vascular disorders	—	—
Ear problem	Ear and labyrinth disorders	—	—
Other problems	General disorders	—	—
Benign tumor	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Most-reported serious reactions: Musculoskeletal problems, Digestive system problem, Cardiac problems, Lymphoma diagnosis, Psychiatric problems, Reproductive system problems, Diabetes diagnosis, Nervous system problem.

Data from ClinicalTrials.gov NCT02246413 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Personalized brain circuit scores identify clinically distinct biotypes in depression and anxiety.
   Tozzi L, Zhang X, Pines A, Olmsted AM, et al · · 2024 · cited 133× · PMID 38886626 · DOI 10.1038/s41591-024-03057-9
2. Mapping Neural Circuit Biotypes to Symptoms and Behavioral Dimensions of Depression and Anxiety.
   Goldstein-Piekarski AN, Ball TM, Samara Z, Staveland BR, et al · · 2022 · cited 118× · PMID 34482948 · DOI 10.1016/j.biopsych.2021.06.024
3. 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.
   Ma J, Rosas LG, Lv N, Xiao L, et al · · 2019 · cited 102× · PMID 30835308 · DOI 10.1001/jama.2019.0557
4. Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial.
   Ma J, Yank V, Lv N, Goldhaber-Fiebert JD, et al · · 2015 · cited 36× · PMID 26096714 · DOI 10.1016/j.cct.2015.06.010
5. The ENGAGE study: Integrating neuroimaging, virtual reality and smartphone sensing to understand self-regulation for managing depression and obesity in a precision medicine model.
   Williams LM, Pines A, Goldstein-Piekarski AN, Rosas LG, et al · · 2018 · cited 28× · PMID 29074231 · DOI 10.1016/j.brat.2017.09.012
6. 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.
   Goldstein-Piekarski AN, Wielgosz J, Xiao L, Stetz P, et al · · 2021 · cited 17× · PMID 34004422 · DOI 10.1016/j.ebiom.2021.103387
7. 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.
   Lv N, Xiao L, Majd M, Lavori PW, et al · · 2020 · cited 15× · PMID 32315362 · DOI 10.1371/journal.pone.0231743
8. Effect of an Intervention for Obesity and Depression on Patient-Centered Outcomes: An RCT.
   Rosas LG, Azar KMJ, Lv N, Xiao L, et al · · 2020 · cited 13× · PMID 32067873 · DOI 10.1016/j.amepre.2019.11.005