NCT02246413

Brief Summary

The RAINBOW study is an NIH R01-funded randomized controlled trial to evaluate the clinical and cost effectiveness and implementation potential of a primary care integrated multicondition intervention program to help improve mood and weight for obese adults with clinically significant depressive symptoms. The ENGAGE study is a mechanistic investigation added to the main trial with funding through the NIH common fund for the Science of Behavior Change roadmap initiative. Beginning Jan 11, 2016, at least 100 of newly enrolled trial participants will be consented to undergo additional assays evaluating neurobiological mechanisms of self-regulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
409

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

September 30, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 11, 2020

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

3.3 years

First QC Date

September 17, 2014

Results QC Date

May 8, 2020

Last Update Submit

April 23, 2024

Conditions

DepressionObesity

Keywords

BMIDepressive symptomsIntegrated therapyCardiometabolic riskSelf-regulationBehavior changePrecision medicineLifestyle

Outcome Measures

Primary Outcomes (2)

  • Co-Primary Outcome: Body Mass Index (BMI)

    Integrated intervention treatment response

    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.

    12 months

Secondary Outcomes (41)

  • Body Mass Index

    24 months

  • Depression Symptom Checklist 20 (SCL-20) Score

    24 months

  • Weight

    12 months

  • Weight

    24 months

  • Depression Remission (Number of Participants With SCL-20 Scores <0.5)

    12 months

  • +36 more secondary outcomes

Study Arms (2)

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.

Behavioral: RAINBOW Intervention Program

Usual Care

NO INTERVENTION

Usual Care.

Interventions

RAINBOW Intervention ProgramBEHAVIORAL

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

RAINBOW Intervention Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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;
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Palo Alto Medical Foundation

Palo Alto, California, 94301, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (12)

  • 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.

    PMID: 39615398DERIVED

  • Zhang 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.

    PMID: 39231241DERIVED

  • Kannampallil 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.

    PMID: 35398399DERIVED

  • Lv 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.

    PMID: 34476464DERIVED

  • Goldstein-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.

    PMID: 34004422DERIVED

  • Lv 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.

    PMID: 33616188DERIVED

  • Goldhaber-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.

    PMID: 32320533DERIVED

  • Lv 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.

    PMID: 32315362DERIVED

  • Rosas 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.

    PMID: 32067873DERIVED

  • Ma 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.

    PMID: 30835308DERIVED

  • Ma 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.

    PMID: 28840096DERIVED

  • Ma 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.

    PMID: 26096714DERIVED

MeSH Terms

Conditions

DepressionObesitySelf-Control

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSocial Behavior

Results Point of Contact

Title
Nan Lv, PhD, Research Scientist
Organization
Univeristy of Illinois, Chicago
lvn2017@uic.edu
312-802-1072

Study Officials

  • Jun Ma, MD, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

  • Leanne Williams, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 17, 2014

First Posted

September 22, 2014

Study Start

September 30, 2014

Primary Completion

January 17, 2018

Study Completion

December 21, 2018

Last Updated

April 26, 2024

Results First Posted

June 11, 2020

Record last verified: 2024-04

Locations

US(2)