Clinical trial NCT03841682: Engaging Self-regulation Targets to Improve Mood and Weight and Understand Mechanism in Depressed and Obese Adults
Official title: Engaging Self-Regulation Targets to Understand the Mechanism of Behavior Change and Improve Mood and Weight Outcomes- Second Phase (ENGAGE-2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Depression
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Stanford University
name: University of Washington
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-02-15
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multimorbidity (i.e., the coexistence of 2 or more chronic conditions in an individual) is increasingly recognized as a pressing public health problem. Effective interventions targeting coexisting depression and obesity are critical given the high prevalence and worsened outcomes for patients with both conditions.

ENGAGE-2 is a pilot randomized controlled trial (RCT). The objective is to investigate the outcomes and mechanisms of an integrated depression and obesity intervention that combines collaborative stepped depression treatment and evidence-based behavioral weight loss treatment. The Integrated Coaching for Better Mood and Weight-2 (I-CARE2) intervention synergistically integrates 2 proven national programs: the Program to Encourage Active and Rewarding Lives (PEARLS) for depression care and the Group Lifestyle Balance (GLB) program for weight loss and cardiometabolic risk reduction.

In Phase 1 of the ENGAGE project, investigators developed a new protocol to quantify activation and connectivity of the Affective, Cognitive Control, and Default Mode brain circuits from functional magnetic resonance imaging (fMRI) among 108 depressed obese patients. Investigators implement the same fMRI protocol in this second phase of the project to examine the mechanistic role of these brain circuits as potential neural targets in treatment engagement and response in the I-CARE2 intervention. A new sample of 105 depressed obese patients are randomized in a 2:1 ratio to receive the I-CARE2 intervention (n=70) or usual care (n=35). Study assessments occur at 0 (baseline), 2 and 6 months. Investigators hypothesize that 1 or more of the neural targets under study will moderate (baseline state) and/or mediate (change at follow-up) the effect of the I-CARE2 intervention versus usual care on health behaviors (problem-solving ability, dietary intakes, physical activity) and clinical outcomes (weight loss, depression, anxiety).

Detailed description: Participants in this study are adult patients with comorbid depression and obesity from outpatient clinics in the University of Illinois Hospital and Health Sciences System (UI Health). Participants will be randomly assigned to receive intervention or usual care control.

The I-CARE2 intervention synergistically integrates the PEARLS program for depression care the GLB program for weight loss. The PEARLS program provides problem-solving therapy (PST) as first-line for treating depression, with as-needed antidepressant medication intensification. Adapted from the original Diabetes Prevention Program, the GLB program promotes healthy lifestyle change for weight loss and increased physical activity. For combination treatment, the I-CARE2 intervention provides 9 individual counseling sessions (4 weekly, 2 biweekly, and then 3 monthly; 1 hour each) and participant self-study materials (GLB videos, handouts, weight and activity tracking) over 6 months.

In response to the funding mechanism for this project, the specific aim of the ENGAGE-2 pilot study is to test the degree to which engaging the validated self-regulation target(s) produces desired behavior change important for weight management and mood.

Eligibility criteria: Inclusion Criteria:

* Age: ≥18 years
* Body mass index based on study measurements at baseline group orientation: ≥30.0 kg/m2 (≥27.0 if Asian), and weight \<350 pounds (due to fMRI scanner size limitations)
* Elevated depressive symptoms as per 9-item Patient Health Questionnaire (PHQ-9) scores ≥10 on study screening
* UI Health patient seen in primary care at least once in the preceding 18 months
* Able and willing to enroll and provide written informed consent

Exclusion Criteria:

* Active suicidal ideation based on PHQ-9 or the 20-item depression symptom checklist (SCL-20) that includes active plan and/or intent
* Any other psychiatric disorder other than persistent depressive disorder and/or major depressive disorder, with the exception of any comorbid anxiety disorder
* Active Bulimia Nervosa within the past 3 months (however Binge Eating Disorder without purging is not an exclusionary condition)
* Active alcohol or substance use disorder (including prescription drugs)
* Currently under the care of a psychiatrist or licensed mental health therapist outside of UI Health
* Had bariatric surgery (e.g., bypass, banding, sleeve, or biliopancreatic diversion with duodenal switch) within the past 12 months or plan to undergo bariatric surgery during the study period
* Pre-existing diabetes (other than during pregnancy)
* Pre-existing cardiovascular disease: e.g., coronary heart disease (myocardial infarction, angina pectoris, percutaneous coronary intervention, and coronary artery bypass graft surgery), cerebrovascular disease (stroke, transient ischemic attack), peripheral vascular disease, heart failure, or aortic aneurysm.
* Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past year
* Severe medical comorbidities that require aggressive treatment, e.g., stage 4 or greater renal disease, and liver failure
* Diagnosis of a terminal illness and/or residence in a long-term care facility
* Cognitive impairment based on the Callahan 6-item screener
* MRI is contraindicated (weight over 350 pounds, traumatic brain injury, tumor or any other known structural abnormality in brain, bullet, shrapnel, or other projectile above the shoulder, not being able to lie down in an fMRI scanner for about an hour due to claustrophobia, personal history of epilepsy, convulsions, or seizures, have piercings that cannot be removed)
* Traumatic brain injury; Tumor or any other known structural abnormality in brain
* Inability to speak, read or understand English
* No reliable telephone service, or no regular Internet access via a computer and/or mobile device (e.g., smartphone)
* Plan to move out of the area or transfer care outside UI Health during the study period
* Currently pregnant, lactating, or planning to become pregnant during the study period
* Already enrolled, or planning to enroll, in another medical or behavioral intervention research study
* Family/household member of another participant or of a staff member
* Investigator discretion for clinical safety or protocol adherence reasons

Primary outcomes:
measure: Change in Depression Symptom Checklist 20 items (SCL-20) at 6 months
timeFrame: Baseline, 6 months
measure: Change in Boby Mass Index (BMI) at 6 months
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Anxiety
timeFrame: Baseline, 6 months
measure: Self-regulation of emotion, cognition, and self-reflection
timeFrame: Baseline, 2 months, 6 months
measure: Change in Depression Symptom Checklist 20 items (SCL-20) at 2 months
timeFrame: Baseline, 2 months
measure: Change in Body Mass Index (BMI) at 2 months
timeFrame: Baseline, 2 months
measure: Anxiety
timeFrame: Baseline, 2 months, 6 months
measure: Dietary Intake
timeFrame: Baseline, 2 months, 6 months
measure: Fruit, vegetable, fat and fiber intake
timeFrame: Baseline, 2 months, 6 months
measure: Physical activity (PA)
timeFrame: Baseline, 2 months, 6 months
measure: Steps
timeFrame: Baseline, 2 months, 6 months
measure: Problem solving
timeFrame: Baseline, 2 months, 6 months
measure: Depression Response
timeFrame: 2 months, 6 months
measure: Complete Depression Remission
timeFrame: 2 months, 6 months
measure: Weight (kg)
timeFrame: Baseline, 2 months, 6 months
measure: Clinically significant weight change from baseline
timeFrame: 2 months, 6 months
measure: Blood pressure
timeFrame: Baseline, 2 months, 6 months
measure: Waist circumference
timeFrame: Baseline, 2 months, 6 months
measure: Sleep and wake function
timeFrame: Baseline, 2 months, 6 months
measure: Perceived stress
timeFrame: Baseline, 6 months
measure: Disability
timeFrame: Baseline, 6 months
measure: Generic health related quality of life
timeFrame: Baseline, 6 months
measure: Obesity-specific health related questions
timeFrame: Baseline, 6 months
measure: Posttraumatic stress disorder
timeFrame: Baseline, 6 months
measure: Pain interference and intensity
timeFrame: Baseline, 6 months
measure: Binge eating severity
timeFrame: Baseline, 6 months
measure: Use of general wellness programs and services questionnaire
timeFrame: 6 months
measure: Self-regulation of emotion, cognition, & self-reflection
timeFrame: Baseline, 2 months, 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Institute for Health Research and Policy (IHRP), Center for Health Behavior Research
state: Illinois
city: Chicago
country: United States
facility: UIMC Advanced Imaging Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Jun Ma, MD,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, Ajilore OA, Ronneberg CR, Venditti EM, Snowden MB, Lavori PW, Xiao L, Goldstein-Piekarski AN, Wielgosz J, Wittels NE, Barve A, Patel AS, Eckley TL, Stetz P, Gerber BS, Smyth JM, Simmons JM, Rosas LG, Williams LM, Ma J. The ENGAGE-2 study: Engaging self-regulation targets to understand the mechanisms of behavior change and improve mood and weight outcomes in a randomized controlled trial (Phase 2). Contemp Clin Trials. 2020 Aug;95:106072. doi: 10.1016/j.cct.2020.106072. Epub 2020 Jul 2.