Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286345
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-05
Brief Title:
Lifestyle InterVEntion Study in General Practice LIVES - GP
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Lifestyle InterVEntion Study in General Practice LIVES - GP
Status:
RECRUITING
Status Verified Date:
2024-02
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:
LIVES-GP
Brief Summary:
Patients with depression are at a substantially increased risk of chronic physical disease including cardiovascular disease This may be attributed primarily to an unhealthy lifestyle related to their disorder Interestingly the unhealthy lifestyle feeds back to decreased quality of life and increased depressive symptoms thus creating a hazardous vicious circle Consequently there is a great potential for Lifestyle Medicine for depression Yet it is known that patients with depression often have motivational and self-management problems Therefore an 18 session multimodal lifestyle intervention MLI specifically tailored to the needs of depressed patients was developed and piloted in mental health care with promising results This research aims to investigate using a process evaluation the feasibility of this MLI in general practice because this is the setting where the majority of patients with depression are treated and results from mental health care are unlikely to apply
Detailed Description:
Rationale Patients with depression are at a substantially increased risk of chronic physical disease including cardiovascular disease This may be attributed primarily to an unhealthy lifestyle related to their disorder Interestingly the unhealthy lifestyle feeds back to decreased quality of life and increased depressive symptoms thus creating a hazardous vicious circle Consequently there is a great potential for Lifestyle Medicine for depression Yet it is known that patients with depression often have motivational and self-management problems Therefore a multimodal lifestyle intervention MLI specifically tailored to the needs of depressed patients was developed and piloted in mental health care with promising results This research aims to investigate this MLI in general practice because this is the setting where the majority of patients with depression are treated and results from mental health care are unlikely to apply
Objective to estimate in general practice the feasibility of conducting a large-scale study on the effectiveness of a MLI for depression and identify key factors that can influence its successful conduct In addition this study aims to obtain an estimate of the variance of outcome measures mental health lifestyle factors functioning recovery wellbeing sleeping quality self-esteem quality of life health care costs anthropometry and blood pressure
Study design An observational single-group prospective cohort study n 50 using mixed methods with baseline measurement and two follow-up measurements after the intervention at 18 weeks and after a follow-up at 42 weeks
Study population Patients 18 years or over with depression and overweight who are being treated in general practice
Intervention if applicable A MLI named in Dutch Gecombineerde Leefstijl Interventie Leef GLI-LEEF developed for patients with depression consisting of several modules eg on physical activity healthy diet comprising both individual and group sessions
Main study parametersendpoints implementation feasibility using three of the elements of the Reach Effectiveness Adoption Implementation Maintenance RE-AIM framework for process evaluation ie Reach Adoption and Implementation
Objective to estimate in general practice the feasibility of conducting a large-scale study on the effectiveness of a MLI for depression and identify key factors that can influence its successful conduct In addition this study aims to obtain an estimate of the variance of outcome measures mental health lifestyle factors functioning recovery wellbeing sleeping quality self-esteem quality of life health care costs anthropometry and blood pressure
Study design An observational single-group prospective cohort study n 50 using mixed methods with baseline measurement and two follow-up measurements after the intervention at 18 weeks and after a follow-up at 42 weeks
Study population Patients 18 years or over with depression and overweight who are being treated in general practice
Intervention if applicable A MLI named in Dutch Gecombineerde Leefstijl Interventie Leef GLI-LEEF developed for patients with depression consisting of several modules eg on physical activity healthy diet comprising both individual and group sessions
Main study parametersendpoints implementation feasibility using three of the elements of the Reach Effectiveness Adoption Implementation Maintenance RE-AIM framework for process evaluation ie Reach Adoption and Implementation
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None