Engaging Self-Regulation Targets to Understand the Mechanism of Behavior Change and Improve Mood and Weight Outcomes- Second Phase (ENGAGE-2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Change in Depression Symptom Checklist 20 items (SCL-20) at 6 months
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
I-CARE2 Intervention
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.
干预措施: I-CARE2 (Behavioral)
Usual Care
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.
结局指标
主要结局
Change in Depression Symptom Checklist 20 items (SCL-20) at 6 months
时间窗: 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
时间窗: Baseline, 6 months
BMI will be calculated based on height and weight measured per standard protocols
次要结局
- 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)
- 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)
- Change in Body Mass Index (BMI) at 2 months(Baseline, 2 months)
- Problem solving(Baseline, 2 months, 6 months)
- Anxiety(Baseline, 2 months, 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)
- Dietary Intake(Baseline, 2 months, 6 months)
- Steps(Baseline, 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)
- Generic health related quality of life(Baseline, 6 months)
- Use of general wellness programs and services questionnaire(6 months)
- Obesity-specific health related questions(Baseline, 6 months)
- Posttraumatic stress disorder(Baseline, 6 months)
- Pain interference and intensity(Baseline, 6 months)
- Binge eating severity(Baseline, 6 months)
- Self-regulation of emotion, cognition, & self-reflection(Baseline, 2 months, 6 months)
- Anxiety(Baseline, 6 months)
研究者
Jun Ma
Professor of Medicine, Director of Center for Health Behavior Research, MD, PhD, FAHA, FABMR
University of Illinois at Chicago