Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older

Официальное название

Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older (IGNITE)

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое vCare Intervention (6-month active treatment followed by 6-month maintenance)
  During the active treatment, participants will interact with the Lumen virtual coach (for depression management) and watch the GLB videos (for weight loss). Using the Amazon Alexa app on their study iPads, participants will complete 4 weekly Lumen PST sessions initially, 2 bi-weekly sessions, and then 3 monthly sessions during the active intervention. Beginning in week 6, participants will receive automated messages with instructions to view one GLB video a week for 11 weeks. During the mainten
• Поведенческое vCare Intervention (active treatment after 6 months)
  During the active treatment, participants will interact with the Lumen virtual coach (for depression management) and watch the GLB videos (for weight loss). Using the Amazon Alexa app on their study iPads, participants will complete 4 weekly Lumen PST sessions initially, 2 bi-weekly sessions, and then 3 monthly sessions during the active intervention. Beginning in week 6, participants will receive automated messages with instructions to view one GLB video a week for 11 weeks.

Первичные конечные точки

• Changes in weight from baseline to 6 months [Срок оценки: From Baseline to 6 months]
• Changes in Depression Symptom Checklist 20-items (SCL-20) from baseline to 6 months [Срок оценки: From Baseline to 6 months]

Вторичные конечные точки (12)

• Changes in weight from baseline to 12 months [Срок оценки: From Baseline to 12 months]
• Changes in Depression Symptom Checklist 20-items (SCL-20) from baseline to 12 months [Срок оценки: From Baseline to 12 months]
• Clinically significant weight change from baseline [Срок оценки: From baseline to 6 months, 12 months]
• Depression Response [Срок оценки: From baseline to 6 months, 12 months]
• Depression Remission [Срок оценки: Baseline, 6 months, 12 months]
• Changes in Generalized Anxiety Disorder 7-item (GAD-7) from baseline to 6, 12 months [Срок оценки: From Baseline to 6 months, 12 months]
• Changes in Sleep disturbance and impairment from baseline to 6, 12 months [Срок оценки: From Baseline to 6 months, 12 months]
• Changes in Sleep impairment from baseline to 6, 12 months [Срок оценки: From Baseline to 6 months, 12 months]
• Changes in functional impairment from baseline to 6, 12 months [Срок оценки: From Baseline to 6 months, 12 months]
• Changes in Cognitive functioning from baseline to 6, 12 months [Срок оценки: From Baseline to 6 months, 12 months]
• Changes in Obesity-related quality of life from baseline to 6, 12 months [Срок оценки: From Baseline to 6 months, 12 months]
• Changes in Generic health-related quality of life from baseline to 6, 12 months [Срок оценки: From Baseline to 6 months, 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Department of Medicine, Vitoux Program on Aging and Prevention — Chicago
• Washington University School of Medicine in St Louis — St Louis

Идентификаторы

NCT: NCT06636058 · 2024-0908 · R01AG084527

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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