Engaging Self-Regulation Targets to Understand the Mechanism of Behavior Change and Improve Mood and Weight Outcomes- Second Phase (ENGAGE-2)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Illinois at Chicago
- Enrollment
- 106
- Locations
- 2
- Primary Endpoint
- Change in Depression Symptom Checklist 20 items (SCL-20) at 6 months
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Jun Ma
Professor of Medicine, Director of Center for Health Behavior Research, MD, PhD, FAHA, FABMR
University of Illinois at Chicago
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
Outcomes
Primary Outcomes
Change in Depression Symptom Checklist 20 items (SCL-20) at 6 months
Time Frame: Baseline, 6 months
The SCL-20 is a valid, reliable measure of depression severity, scores ranging from 0 (best) to 4 (worst). SCL-20 cutoff points of 1.5 and 2.0 correspond to moderate and severe depression, respectively. It has been used in numerous depression treatment trials in primary care and community settings, making it particularly useful for cross-study comparisons and data synthesis in meta-analyses.
Change in Boby Mass Index (BMI) at 6 months
Time Frame: Baseline, 6 months
BMI will be calculated based on height and weight measured per standard protocols
Secondary Outcomes
- Change in Body Mass Index (BMI) at 2 months(Baseline, 2 months)
- Anxiety(Baseline, 2 months, 6 months)
- Self-regulation of emotion, cognition, and self-reflection(Baseline, 2 months, 6 months)
- Problem solving(Baseline, 2 months, 6 months)
- Change in Depression Symptom Checklist 20 items (SCL-20) at 2 months(Baseline, 2 months)
- Dietary Intake(Baseline, 2 months, 6 months)
- Steps(Baseline, 2 months, 6 months)
- Fruit, vegetable, fat and fiber intake(Baseline, 2 months, 6 months)
- Physical activity (PA)(Baseline, 2 months, 6 months)
- Depression Response(2 months, 6 months)
- Complete Depression Remission(2 months, 6 months)
- Sleep and wake function(Baseline, 2 months, 6 months)
- Perceived stress(Baseline, 6 months)
- Disability(Baseline, 6 months)
- Weight (kg)(Baseline, 2 months, 6 months)
- Clinically significant weight change from baseline(2 months, 6 months)
- Blood pressure(Baseline, 2 months, 6 months)
- Waist circumference(Baseline, 2 months, 6 months)
- Generic health related quality of life(Baseline, 6 months)
- Use of general wellness programs and services questionnaire(6 months)
- Binge eating severity(Baseline, 6 months)
- Obesity-specific health related questions(Baseline, 6 months)
- Posttraumatic stress disorder(Baseline, 6 months)
- Pain interference and intensity(Baseline, 6 months)
- Self-regulation of emotion, cognition, & self-reflection(Baseline, 2 months, 6 months)