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

2021年10月13日 更新者：Jun Ma、University of Illinois at Chicago

Engaging Self-Regulation Targets to Understand the Mechanism of Behavior Change and Improve Mood and Weight Outcomes- Second Phase (ENGAGE-2)

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).

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

106

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Illinois
      • Chicago、Illinois、美国、60612
        • UIMC Advanced Imaging Center
      • Chicago、Illinois、美国、60608
        • Institute for Health Research and Policy (IHRP), Center for Health Behavior Research

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
行为的：I-CARE2

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.
无干预：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Depression Symptom Checklist 20 items (SCL-20) at 6 months
大体时间：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.
Baseline, 6 months
Change in Boby Mass Index (BMI) at 6 months
大体时间：Baseline, 6 months
BMI will be calculated based on height and weight measured per standard protocols
Baseline, 6 months

次要结果测量

结果测量
措施说明
大体时间
Anxiety
大体时间：Baseline, 6 months
Anxiety is measured using Panic Disorder module of the Mini-International Neuropsychiatric Interview (MINI).
Baseline, 6 months
Self-regulation of emotion, cognition, and self-reflection
大体时间：Baseline, 2 months, 6 months
fMRI scan will be used to evaluate 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
大体时间：Baseline, 2 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, 2 months
Change in Body Mass Index (BMI) at 2 months
大体时间：Baseline, 2 months
BMI will be calculated based on height and weight measured per standard protocols
Baseline, 2 months
Anxiety
大体时间：Baseline, 2 months, 6 months
Anxiety is measured using Generalized Anxiety Disorder Scale (GAD-7).
Baseline, 2 months, 6 months
Dietary Intake
大体时间：Baseline, 2 months, 6 months
Dietary intake will be recorded using 24-hours dietary recalls
Baseline, 2 months, 6 months
Fruit, vegetable, fat and fiber intake
大体时间：Baseline, 2 months, 6 months
17-item fruit, vegetable, fat, and fiber screener will be used.
Baseline, 2 months, 6 months
Physical activity (PA)
大体时间：Baseline, 2 months, 6 months
PA will be measured using 7-day Physical Activity Recall
Baseline, 2 months, 6 months
Steps
大体时间：Baseline, 2 months, 6 months
Steps will be calculated using Fitbit
Baseline, 2 months, 6 months
Problem solving
大体时间：Baseline, 2 months, 6 months
Problem Solving will be evaluated using Social Problem-Solving Inventory-Revised: Short Form
Baseline, 2 months, 6 months
Depression Response
大体时间：2 months, 6 months
This will be evaluated using depression symptom checklist SCL-20 (50% decline in SCL-20 scores from baseline)
2 months, 6 months
Complete Depression Remission
大体时间：2 months, 6 months
Evaluated using depression symptom checklist SCL-20 (SCL-20 <0.5)
2 months, 6 months
Weight (kg)
大体时间：Baseline, 2 months, 6 months
Measured using a weight scale. Missing study-measured weight may be replaced with weight from electronic health records or self-reported weight.
Baseline, 2 months, 6 months
Clinically significant weight change from baseline
大体时间：2 months, 6 months
Dichotomous variable based on if participants reaching 5% weight loss from baseline.
2 months, 6 months
Blood pressure
大体时间：Baseline, 2 months, 6 months
The American Heart Association recommendations for BP measurement will be followed. BP will be measured in the seated position after at least a 5-minute rest in a separate, quiet room where no other activity is taking place and where temperature fluctuations are minimal. At baseline, both arms will be measured once and 2 more times on the arm with higher systolic reading using standard equipment. This same arm will be measured 3 times at each follow-up assessment. Wait 1 minute between each measurement.
Baseline, 2 months, 6 months
Waist circumference
大体时间：Baseline, 2 months, 6 months
Waist circumference will be measured using a study-provided body tape measure placed on bare skin in a horizontal plane around the abdomen at the uppermost lateral border of the right iliac crest. Waist circumference will be measured to the nearest 0.1 centimeters. Two measurements will be taken, and if the measurements differ by 1.0 cm or more, then take a third.
Baseline, 2 months, 6 months
Sleep and wake function
大体时间：Baseline, 2 months, 6 months
Sleep quality will be assessed on the 8-item Patient-Reported Outcomes Measurement Information System (PROMIS™) sleep disturbance (SD) and sleep-related impairment (SRI) scales short forms. The former measures symptoms of insomnia and the latter measures symptoms of daytime sleepiness. Each item is scaled from 1 (not at all) to 5 (very much). Correlation between the SD short form and the Pittsburgh Sleep Quality Index (PSQI, hypothesized to measure similar attributes) is 0.83 and correlation between the SRI short form and the Epworth Sleepiness Scale (ESS, hypothesized to measure a related but slightly different construct, the propensity to doze during activities) is 0.46, similar to the correlations between the SD full banks and PSQI (0.85) and between SRI full banks and the ESS (0.45).
Baseline, 2 months, 6 months
Perceived stress
大体时间：Baseline, 6 months
Perceived stress is measured using Perceived stress scale (PSS). PSS measures the perception of stress (i.e., the degree to which situations in one's life are appraised as stressful). PSS contains 14 items, rated on a 5-point scale ranging from "never" to "very often." After reversing the scores on 7 positive items, a sum of score is calculated with higher score indicating higher perceived stress. Cronbach's alpha ranged from 0.84 to 0.86.
Baseline, 6 months
Disability
大体时间：Baseline, 6 months
Disability is measured using Sheehan Disability Scale. The Sheehan Disability Scale is a validated questionnaire that measures functional disability and is sensitive to treatment effects in clinical trials. Patients rate the extent to which their symptoms impair work/school, social, and family life on a visual analog scale from0 to 10 and answer the number of days when their symptoms cause them to miss work/school and be unproductive at work/school.
Baseline, 6 months
Generic health related quality of life
大体时间：Baseline, 6 months
Generic health related quality of life is measured using SF-8 Health Survey. The SF-8 is an 8-item version of the SF-36 that measures overall health-related quality of life. Physical and mental health composite scores are computed using the scores of 8 questions and range from 0 to 100, with 0 indicating the lowest level of health and 100 indicating the highest level of health. Correlation between the SF-8 and the SF-36 is 0.825 for physical health component and 0.881 for mental health component.
Baseline, 6 months
Obesity-specific health related questions
大体时间：Baseline, 6 months
The Obesity-Related Problem Scale specifically measures the impact of obesity on psychosocial functioning. The 8-item scale has high internal reliability and sound test-retest reliability, correlates strongly with a wide range of theoretically related constructs, and is responsive to weight loss intervention.
Baseline, 6 months
Posttraumatic stress disorder
大体时间：Baseline, 6 months
Posttraumatic stress disorder is measured using the 17-item PTSD checklist - Civilian Version (PCL-C) that has high reliability and validity.
Baseline, 6 months
Pain interference and intensity
大体时间：Baseline, 6 months
Pain is measured using PROMIS SF - Pain Interference 4a and Numeric Rating Scale - Pain Intensity 1a.
Baseline, 6 months
Binge eating severity
大体时间：Baseline, 6 months
Binge eating severity is measured using the Binge eating severity scale.
Baseline, 6 months
Use of general wellness programs and services questionnaire
大体时间：6 months
This questionnaire asks participants if they have received a list of wellness programs and services for general physical and mental well-being in the past 6 months.
6 months
Self-regulation of emotion, cognition, & self-reflection
大体时间：Baseline, 2 months, 6 months
BiAffect (Smart phone passive data collection) will be used, as an alternative, to evaluate self-regulation of emotion, cognition, and self-reflection
Baseline, 2 months, 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Illinois at Chicago

合作者

National Heart, Lung, and Blood Institute (NHLBI)
University of Washington
Stanford University

调查人员

  • 首席研究员：Jun Ma, MD,PhD、University of Illinois at Chicago

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年3月1日

初级完成 (实际的)

2020年8月31日

研究完成 (实际的)

2021年8月31日

研究注册日期

首次提交

2019年2月2日

首先提交符合 QC 标准的

2019年2月12日

首次发布 (实际的)

2019年2月15日

研究记录更新

最后更新发布 (实际的)

2021年10月21日

上次提交的符合 QC 标准的更新

2021年10月13日

最后验证

2021年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2018-1174
  • UH3HL132368 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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