Engaging Self-regulation Targets to Improve Mood and Weight and Understand Mechanism in Depressed and Obese Adults

NCT03841682 | Completed DMC

• 2 other identifiers: 2018-1174UH3HL132368
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

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).

Conditions

Obesity; Depression

Outcome Measures

Primary Outcomes (2)

• Change in Depression Symptom Checklist 20 items (SCL-20) at 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.

  Baseline, 6 months

• Change in Boby Mass Index (BMI) at 6 months

  BMI will be calculated based on height and weight measured per standard protocols

  Baseline, 6 months

Secondary Outcomes (26)

• Anxiety

  Baseline, 6 months

• Self-regulation of emotion, cognition, and self-reflection

  Baseline, 2 months, 6 months

• Change in Depression Symptom Checklist 20 items (SCL-20) at 2 months

  Baseline, 2 months

• Change in Body Mass Index (BMI) at 2 months

  Baseline, 2 months

• Anxiety

  Baseline, 2 months, 6 months

Study Arms (2)

I-CARE2 Intervention

EXPERIMENTAL

Participants should continue with their usual medical care. Additionally, participant receive the I-CARE2 intervention. Trained health coaches deliver the I-CARE2 intervention over 6 months. The intervention provides 9 individual counseling sessions on problem solving treatment and behavior counselling to manage mood and lose weight (4 weekly, 2 biweekly, and then 3 monthly; 1 hour each), 11 home-viewed GLB videos (weekly; 20-30 minutes each), and self-study and self-monitoring activities. Throughout the intervention, participants are asked to wear and sync a study-provided Fitbit pedometer, and to log their weight, minutes of physical activity, and dietary intake using the Fitbit website or mobile app.

Behavioral: I-CARE2

Usual Care

NO INTERVENTION

Participants should continue with their Usual Medical Care. Additionally, participants receive information on wellness and behavioral health promotion at UI Health and a Fitbit pedometer.

Interventions

I-CARE2 BEHAVIORAL

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. 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.

I-CARE2 Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Stanford University: collaborator
• University of Washington: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Institute for Health Research and Policy (IHRP), Center for Health Behavior Research

Chicago, Illinois, 60608, United States

Location

UIMC Advanced Imaging Center

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

• Lv N, Hallihan H, Xiao L, Williams LM, Ajilore OA, Ma J. Association of Changes in Neural Targets and Dietary Outcomes among Patients with Comorbid Obesity and Depression: Post hoc Analysis of ENGAGE-2 Mechanistic Clinical Trial. J Nutr. 2023 Mar;153(3):880-896. doi: 10.1016/j.tjnut.2023.01.022. Epub 2023 Jan 23.

  PMID: 36931755 DERIVED

• Burton TC, Lv N, Tsai P, Penalver Bernabe B, Tussing-Humphreys L, Xiao L, Pandey GN, Wu Y, Ajilore OA, Ma J. Associations between fecal short-chain fatty acids, plasma inflammatory cytokines, and dietary markers with depression and anxiety: Post hoc analysis of the ENGAGE-2 pilot trial. Am J Clin Nutr. 2023 Apr;117(4):717-730. doi: 10.1016/j.ajcnut.2023.01.018. Epub 2023 Feb 1.

  PMID: 36796440 DERIVED

• 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: 35398399 DERIVED

• 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.

  PMID: 32621905 DERIVED

MeSH Terms

Conditions

Obesity; Depression

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Jun Ma, MD,PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Director of Center for Health Behavior Research, MD, PhD, FAHA, FABMR

Study Record Dates

• First Submitted: February 2, 2019
• First Posted: February 15, 2019
• Study Start: March 1, 2019
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2021
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

US (2)