RCT on Co-management of Obesity, Depression, and Elevated CVD Risk in Primary Care-- Engaging Self-regulation Targets to Understand the Mechanisms of Behavior Change and Improve Mood and Weight Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 409
- 试验地点
- 2
- 主要终点
- Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) Score
研究概览
简要总结
The RAINBOW study is an NIH R01-funded randomized controlled trial to evaluate the clinical and cost effectiveness and implementation potential of a primary care integrated multicondition intervention program to help improve mood and weight for obese adults with clinically significant depressive symptoms. The ENGAGE study is a mechanistic investigation added to the main trial with funding through the NIH common fund for the Science of Behavior Change roadmap initiative. Beginning Jan 11, 2016, at least 100 of newly enrolled trial participants will be consented to undergo additional assays evaluating neurobiological mechanisms of self-regulation.
详细描述
The large numbers of primary care patients affected by coexisting obesity and depression and common risk factors for diabetes and heart disease underscore the urgency of developing effective, accessible, and sustainable interventions that use an integrated, multicondition care management approach. The RAINBOW trial will rigorously evaluate the clinical and cost effectiveness and potential for "real-world" implementation of an innovative intervention that integrates a behavioral weight loss program and a collaborative stepped care program for depression, incorporates conventional clinic- and home-based modes of care delivery (e.g., office visits plus phone consults and take-home DVD), and leverages low-cost, wide-reach health information technologies (e.g., Web, secure email, and mobile texting). Beginning Jan 11, 2016, at least 100 of newly enrolled trial participants will also be consented to undergo additional assays evaluating neurobiological mechanisms of self-regulation, including emotional regulation, cognitive control and self-reflection. Given its focus on transforming primary care management of obesity and depression and common cardiometabolic risk factors to evidence-based, patient-centered care, as well as the likely scalability of the proposed intervention, the study has high potential for significant clinical and public health impact. Furthermore, elucidating the neurobiological mechanisms of self-regulation will significantly advance precision lifestyle medicine by enabling mechanism-targeted individualization of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •Inclusion criteria:
- •Ethnicity and race: Any;
- •Obesity: BMI≥30 kg/m2 for non-Asians; BMI≥27 kg/m2 for Asians;
- •Clinically significant depressive symptoms: PHQ-9≥10;
- •A PAMF patient for ≥1 year
- •Seen in primary care at least once in the preceding 24 months;
- •Able and willing to enroll and meet the requirements of the study
排除标准
- •Inability to speak, read or understand English;
- •Having no reliable telephone service, no device to use to watch a DVD, or no regular Internet access via a computer and/or mobile device;
- •Had bariatric surgery within the past 12 months or plans to undergo bariatric surgery during the 24-month study period;
- •Ongoing psychiatric care outside of the PAMF network.
- •Active suicidal ideation that includes active plan and/or intent;
- •Any Axis I disorder other than Minor or Major Depressive Disorder and/or Dysthymia, with the exception of any comorbid Anxiety Disorder;
- •Active Bulimia Nervosa within the past 12 months (however Binge Eating Disorder without purging is not an exclusionary condition);
- •Active alcohol or substance use disorder (including prescription drugs).
- •Pre-existing diabetes (other than during pregnancy) or diabetes diagnosed as a result of fasting blood glucose or hemoglobin A1c levels obtained through study screening;
- •Pre-existing cardiovascular disease.
- •Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 12 months;
- •Severe medical comorbidities that require aggressive treatment, e.g., stage 4 or greater renal disease, liver failure;
- •Diagnosis of a terminal illness and/or in hospice care;
- •Residence in long-term care facility;
- •Cognitive impairment based on the Callahan 6-item scale
- •Plan to move out of the area or transfer care outside PAMF during the study period;
- •Investigator discretion for reasons of clinical safety or protocol adherence.
- •Inclusion criteria:
- •RAINBOW participant
- •Exclusion criteria:
- •Weight over 350 pounds
- •MRI is contraindicated
- •Traumatic brain injury
研究组 & 干预措施
RAINBOW Intervention Program
An integrated intervention program for helping to improve mood and weight in adults who may be at risk for diabetes and heart disease.
干预措施: RAINBOW Intervention Program (Behavioral)
Usual Care
Usual Care.
结局指标
主要结局
Co-Primary Outcome: Depression Symptom Checklist 20 (SCL-20) Score
时间窗: 12 months
Depression Symptom Checklist 20 (SCL-20) questionnaire score. SCL-20, average scores of the 20 items with a range from 0 (not at all) to 4 (extremely). SCL-20 cutoff points scores of ≤0.75, \>0.75-1.5, \>1.5- 2.0, and \>2.0 represent remission, mild depression, moderate depression, and severe depression, respectively.
Co-Primary Outcome: Body Mass Index (BMI)
时间窗: 12 months
Integrated intervention treatment response
次要结局
- Depression Symptom Checklist 20 (SCL-20) Score(24 months)
- Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )(24 months)
- Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )(24 months)
- Disability (Sheehan Disability Scale)(24 months)
- Anxiety (GAD-7)(24 months)
- Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)(24 months)
- Sleep Disturbance T-score(24 months)
- Sleep Impairment T-score(24 months)
- Total Calorie Intake(One day's 24-hour dietary recall was administered at 12 months)
- Body Mass Index(24 months)
- Weight(24 months)
- Depression Remission (Number of Participants With SCL-20 Scores <0.5)(12 months)
- Depression Remission (Number of Participants With SCL-20 Score <0.5)(24 months)
- Leisure Time Physical Activity(7-day Physical Activity Recall was administered at 12 months)
- Total Energy Expenditure(7-day Physical Activity Recall was administered at 12 months)
- Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)(24 months)
- Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)(24 months)
- Cost-effectiveness(12 months)
- Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)(24 months)
- Utility-based Health-related Quality of Life (EQ-5D-Activity)(24 months)
- Utility-based Health-related Quality of Life (EQ-5D-Pain)(24 months)
- Utility-based Health-related Quality of Life (EQ-5D-Mobility)(24 months)
- Change in Activation of Left Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion)(Baseline, 2 months)
- Change in Activation of Right Amygdala From Baseline Functional Magnetic Resonance Scan at 2 Months (Regulation of Emotion)(Baseline, 2 months)
- Utility-based Health-related Quality of Life (EQ-5D-Self-care)(24 months)
- DASH (Dietary Approach to Stop Hypertension) Score(One day's 24-hour dietary recall was administered at 12 months)
- Weight(12 months)
- Depression Treatment Response (Number of Participants With ≥50% Decrease in SCL-20 Scores From Baseline)(12 months)
- Clinically Significant Weight Loss (Number of Participants With ≥5% Weight Loss From Baseline)(12 months)
- Obesity-related Psychosocial Functioning (Obesity-related Problem Scale)(12 months)
- Anxiety (GAD-7)(12 months)
- Generic Health-related Quality of Life (SF-8 - Physical Component (PCS) )(12 months)
- Generic Health-related Quality of Life (SF-8 - Mental Component (MCS) )(12 months)
- Disability (Sheehan Disability Scale)(12 months)
- Utility-based Health-related Quality of Life (EQ-5D-Activity)(12 months)
- Utility-based Health-related Quality of Life (EQ-5D-Pain)(12 months)
- Utility-based Health-related Quality of Life (EQ-5D-Anxiety/Depression)(12 months)
- Utility-based Health-related Quality of Life (EQ-5D-Mobility)(12 months)
- Utility-based Health-related Quality of Life (EQ-5D-Self-care)(12 months)
- Sleep Disturbance T-score(12 months)
- Sleep Impairment T-score(12 months)
研究者
Jun Ma, MD, PhD
Professor
University of Illinois at Chicago