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Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older (IGNITE)
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.
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.
Age
50 - 74 years
Sex
ALL
Healthy Volunteers
No
Department of Medicine, Vitoux Program on Aging and Prevention
Chicago, Illinois, United States
Washington University School of Medicine in St Louis
St Louis, Missouri, United States
Start Date
January 21, 2025
Primary Completion Date
April 14, 2028
Completion Date
October 13, 2028
Last Updated
February 27, 2025
440
ESTIMATED participants
vCare Intervention (6-month active treatment followed by 6-month maintenance)
BEHAVIORAL
vCare Intervention (active treatment after 6 months)
BEHAVIORAL
Lead Sponsor
University of Illinois at Chicago
Collaborators
NCT01143454
NCT07360600
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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