Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-01 @ 6:25 PM
Study NCT ID:
NCT06636058
Status:
RECRUITING
Last Update Posted:
2025-02-27
First Post:
2024-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older
Sponsor:
University of Illinois at Chicago
Organization:
Study Overview
Official Title:
Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older (IGNITE)
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IGNITE
Brief Summary:
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.
* 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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01AG084527 | NIH | None | https://reporter.nih.gov/quic… | View |