Digital InteGrated Behavioral treatmeNt for Comorbid obesITy and deprEssion Among Racial and Ethnic Adults Age 50 and Older (IGNITE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 5
- 主要终点
- Changes in weight from baseline to 6 months
研究概览
简要总结
The goal of this randomized clinical trial is to test the efficacy of a fully digital intervention, combining the Lumen problem-solving therapy virtual coach for depression management with the Diabetes Prevention Program video-based program for weight loss, among racial and ethnic minorities with comorbid depression and obesity. The study aims include:
- Determine the efficacy of the vCare intervention at 6 months. Primary outcomes are weight and depression symptom checklist 20-item (SCL-20) score.
- Identify predictors of treatment success, defined by achieving clinically significant weight loss (5%) and depression outcomes (50% decline or SCL-20<0.5), at 6 and 12 months.
- Characterize participant experiences and perceptions of the vCare intervention. Eligible participants will be randomized to the early-intervention arm who will receive active treatment for 6 months, followed by maintenance for another 6 months, or the later-intervention arm who will be waitlisted for 6 months and then receive active treatment in the second 6 months.
详细描述
The objective of this project is to test the efficacy of a fully digital intervention, combining the Lumen problem-solving treatment (PST) virtual coach for depression management with the Diabetes Prevention Program (DPP) video-based program for weight loss. This integrated intervention is named vCare. Patients self-identified as a racial or ethnic minority with depression and obesity will be enrolled from a large minority-serving academic medical center in Chicago.
In this fully remote clinical trial, participants will receive a study iPad, a wireless weight scale, and a wearable activity tracker. Eligible participants who complete baseline assessment (N=440) will be randomly assigned in 1:1 ratio to receive the vCare intervention early (for 6 months of active treatment and 6 months of maintenance) or later (for 6 months waitlist control and 6 months of active treatment). Participants in either the early- or later-intervention arm will be assessed at 6 and 12 months follow-up.
The specific aims of this study are to (1) determine the intervention efficacy to improve the primary depressive symptoms and weight loss outcomes and secondary outcomes (e.g., anxiety, sleep, quality of life, social isolation, loneliness, and psychosocial and cognitive functioning) at 6 months; (2) identify predictors of treatment success, defined by clinically significant weight loss (5%) and depression response (50% symptom reduction) or remission (free of symptoms), at 6 and 12 months; and (3) characterize the experiences and perceptions of intervention participants to inform future adaptation and translation.
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
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-74 years (inclusive)
- •Confirmed body mass index (BMI) between ≥27.0 and <45.0 based on weight and height measured by study staff at device distribution
- •Confirmed weight ≤396 lbs
- •Patient Health Questionnaire-9 (PHQ-9) scores between ≥10 and <20, indicating moderate to moderately severe depressive symptoms
- •Self-identified race and ethnicity other than non-Hispanic White
- •Willing and able to accept randomization, and provide informed e-consent and HIPAA authorization
排除标准
- •Unable to speak, read, understand English sufficiently for informed consent
- •No reliable Wi-Fi Internet access at home
- •Pre-existing type 1 or type 2 diabetes, coronary heart disease, heart failure, stroke, cancer diagnosis (other than non-melanoma skin cancer) or treatment in the past 12 months, end-stage organ failure, residence in a long-term care facility, life expectancy <24 months
- •Self-report of weight change >15 lbs. during prior 3 months
- •Current active weight loss treatment, including research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS), other programs led by trained personnel (professional or lay) at the recruiting clinic or in the local community
- •Taking prescription medications regularly that affect appetite/weight (e.g., anti-obesity medicines, oral corticosteroids, oral hypoglycemics, etc.) for chronic disease management
- •Planned or prior bariatric surgery (Note: patients who are more than 2 years post bariatric surgery may otherwise be eligible)
- •Screen positive for bulimia nervosa using PHQ- eating disorder module
- •Unable to pass the Revised Physical Activity Readiness Questionnaire (PAR-Q) or obtain physician clearance to participate
- •Active suicidal ideation (PHQ-9 item 9 score ≥1 or SCL-20 item 2 score ≥2) with active plan and/or intent
- •Bipolar or psychotic disorder, or pharmacotherapy or psychotherapy (individual or professionally-led group therapy), or brain stimulation therapy for depression or any other psychiatric condition
- •Cognitive impairment based on the Callahan 6-item screener
- •Active alcohol or substance use disorder (including prescription drugs) based on the CAGE Questionnaire Adapted to Include Drugs (CAGE-AID)
- •Current or planned pregnancy or lactating (<6 months postpartum)
- •Participation in other behavioral, medical or surgical treatment studies by self-report that conflict with the primary weight loss and depression outcomes of this study
- •Family/household member of an already enrolled participant or of a study team member
- •Investigator discretion for serious safety or protocol adherence reasons
研究组 & 干预措施
Early VCare Intervention (6-month active treatment followed by 6-month maintenance)
Participants randomized to the early-intervention arm will receive active treatment for 6 months, followed by maintenance for another 6 months.
干预措施: vCare Intervention (6-month active treatment followed by 6-month maintenance) (Behavioral)
Later Waitlist VCare Intervention (active treatment after 6 months)
Participants in the later-intervention arm will be waitlisted for 6 months and then receive active treatment in the second 6 months.
干预措施: vCare Intervention (active treatment after 6 months) (Behavioral)
结局指标
主要结局
Changes in weight from baseline to 6 months
时间窗: From Baseline to 6 months
All participants will receive a study-provided wireless weight scale (Withings Body - Digital Wi-Fi Smart Scale), assistance with account and device setup, and as-needed tech support. A study coordinator who is blinded to randomization will proactively contact participants by phone, email, and/or text to remind them to weigh themselves in the morning after urination (and a bowel movement too, if able to do so) on 3 days during the assessment week at baseline (0), 6, 12 months. Participants will be instructed to self-weigh in a T-shirt and undergarment and with no socks or shoes using their study-provided digital scale. We will obtain participants' self-monitored weight data using a developed program for automated daily synchronization via the Fitbit open API.
Changes in Depression Symptom Checklist 20-items (SCL-20) from baseline to 6 months
时间窗: From Baseline to 6 months
The SCL-20 is a valid, reliable measure of depression severity. 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. The SCL-20 had good internal consistency (Cronbach's alpha=0.859) and correlated well with the General Health Questionnaire (r=0.78), a psychiatric screening test.
次要结局
- Changes in weight from baseline to 12 months(From Baseline to 12 months)
- Changes in Depression Symptom Checklist 20-items (SCL-20) from baseline to 12 months(From Baseline to 12 months)
- Clinically significant weight change from baseline(From baseline to 6 months, 12 months)
- Depression Response(From baseline to 6 months, 12 months)
- Depression Remission(Baseline, 6 months, 12 months)
- Changes in Generalized Anxiety Disorder 7-item (GAD-7) from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in Sleep disturbance and impairment from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in Sleep impairment from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in functional impairment from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in Cognitive functioning from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in Obesity-related quality of life from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in Generic health-related quality of life from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in Social isolation from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in loneliness from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in physical activity from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in sleep metrics from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in diet intake from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in problem-solving ability from baseline to 6, 12 months(From Baseline to 6 months, 12 months)
- Changes in food insecurity from baseline to 12 months(From Baseline to 12 months)
研究者
Jun Ma
MD, PhD, Principal Investigator, Beth and George Vitoux Professor of Medicine Affiliation: University of Illinois at Chicago
University of Illinois at Chicago