Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636058
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older IGNITE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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-2005 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-2005 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 N440 will be randomly assigned in 11 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 eg 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 N440 will be randomly assigned in 11 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 eg 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None