Clinical trial NCT02246413: Research Aimed at Improving Both Mood and Weight
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Obesity
Keywords: BMI
Depressive symptoms
Integrated therapy
Cardiometabolic risk
Self-regulation
Behavior change
Precision medicine
Lifestyle
Lead sponsor: Palo Alto Medical Foundation
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Washington
name: University of Pittsburgh
name: Stanford University
name: University of Illinois at Chicago
name: Sutter Health
First posted: 2014-09-22
Enrollment: 409
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Co-Primary Outcome: Body Mass Index (BMI)
timeFrame: 12 months
measure: Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) Score
timeFrame: 12 months
Secondary outcomes:
measure: Body Mass Index
timeFrame: 24 months
measure: Depression Symptom Checklist 20 (SCL-20) Score
timeFrame: 24 months
measure: Weight
timeFrame: 12 months
measure: Weight
timeFrame: 24 months
measure: Depression Remission (Number of Participants With SCL-20 Scores <0.5)
timeFrame: 12 months
measure: Depression Remission (Number of Participants With SCL-20 Score <0.5)
timeFrame: 24 months
measure: Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)
timeFrame: 12 months
measure: Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)
timeFrame: 24 months
measure: Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)
timeFrame: 12 months
measure: Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)
timeFrame: 24 months
measure: Cost-effectiveness
timeFrame: 12 months
measure: Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)
timeFrame: 12 months
measure: Anxiety (GAD-7)
timeFrame: 12 months
measure: Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )
timeFrame: 12 months
measure: Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )
timeFrame: 12 months
measure: Disability (Sheehan Disability Scale)
timeFrame: 12 months
measure: Utility-based Health-related Quality of Life (EQ-5D-Activity)
timeFrame: 12 months
measure: Utility-based Health-related Quality of Life (EQ-5D-Pain)
timeFrame: 12 months
measure: Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)
timeFrame: 12 months
measure: Utility-based Health-related Quality of Life (EQ-5D-Mobility)
timeFrame: 12 months
measure: Utility-based Health-related Quality of Life (EQ-5D-Self-care)
timeFrame: 12 months
measure: Sleep Disturbance T-score
timeFrame: 12 months
measure: Sleep Impairment T-score
timeFrame: 12 months
measure: Change in Activation of Left Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion)
timeFrame: Baseline, 2 months
measure: Change in Activation of Right Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion)
timeFrame: Baseline, 2 months
measure: Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)
timeFrame: 24 months
measure: Anxiety (GAD-7)
timeFrame: 24 months
measure: Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )
timeFrame: 24 months
measure: Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )
timeFrame: 24 months
measure: Disability (Sheehan Disability Scale)
timeFrame: 24 months
measure: Utility-based Health-related Quality of Life (EQ-5D-Activity)
timeFrame: 24 months
measure: Utility-based Health-related Quality of Life (EQ-5D-Pain)
timeFrame: 24 months
measure: Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)
timeFrame: 24 months
measure: Utility-based Health-related Quality of Life (EQ-5D-Mobility)
timeFrame: 24 months
measure: Utility-based Health-related Quality of Life (EQ-5D-Self-care)
timeFrame: 24 months
measure: Sleep Disturbance T-score
timeFrame: 24 months
measure: Sleep Impairment T-score
timeFrame: 24 months
measure: Leisure Time Physical Activity
timeFrame: 7-day Physical Activity Recall was administered at 12 months
measure: Total Energy Expenditure
timeFrame: 7-day Physical Activity Recall was administered at 12 months
measure: Total Calorie Intake
timeFrame: One day's 24-hour dietary recall was administered at 12 months
measure: DASH (Dietary Approach to Stop Hypertension) Score
timeFrame: One day's 24-hour dietary recall was administered at 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: University of Illinois at Chicago
name: Jun Ma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Leanne Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.