Lifestyle InterVEntion Study in General Practice: LIVES - GP

Cardiovascular Diseases Clinical Trial

— LIVES-GP  

Official title:

Lifestyle InterVEntion Study in General Practice: LIVES - GP

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06286345
• Other study ID #: 17644
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: February 2024
• Source: University Medical Center Groningen
• Contact: Huibert Burger, MD PhD
• Phone: +31(0)50 361 6722
• Email: h.burger[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (e.g. on physical activity, healthy diet) comprising both individual and group sessions.

Main study parameters/endpoints: implementation feasibility using three of the elements of the 'Reach, Effectiveness, Adoption, Implementation, Maintenance' (RE-AIM) framework for process evaluation (i.e. Reach, Adoption and Implementation)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of depressive symptoms or depressive disorder in the past year as registered in the general practice electronic health record and coded according to the International Classification of Primary Care (ICPC) as P03 and P76, respectively, or currently treated for depressive symptoms or depressive disorder in general practice.

• At least mild depressive symptom level according to the Quick Inventory Depressive Symptomatology-Self-Report (QIDS-SR) (score =6)

• Body mass index = 25 kg/m2 or increased waist circumference (>88 cm (women) of >102 cm (men)).

Exclusion Criteria:

• Current treatment in mental health care (GGZ in Dutch)

• Severe somatic / neurological disease at the discretion of the GP

• Currently participating in another lifestyle intervention

• Insufficient proficiency in Dutch

• Inability to read and write

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Depression
• Depression, Unipolar
• Depressive Disorder

Intervention

Behavioral:
• GLI-LEEF
GLI-LEEF is an 18-week program, during which various lifestyle topics are discussed, such as nutrition, exercise, sleep, relationships and intimacy, and specific education about depression and its influence on lifestyle. GLI-LEEF is aimed at improving the activity level, quality of life and (cardiovascular) health of patients and thus increasing the general functioning and well-being of patients and at the same time reducing psychological complaints. GLI-LEEF consists of 14 group meetings and 4 individual meetings, the group meetings last 90 minutes, the individual meetings 30 minutes. Patients are asked to wear a FitBit and to complete short homework assignments. Each group contains 8-10 patients. Patients are asked to find a buddy who can support them during the program.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	GGZ Drenthe Mental Health Institution

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reach of GLI-LEEF	Reach of GLI-LEEF as defined as the number of individuals who are willing to participate in this study	12 months
Primary	General practice adoption of GLI-LEEF	General practice adoption of GLI-LEEF as defined by the number of general practices that are willing to implement GLI-LEEF in this study	12 months
Primary	General practitioner adoption of GLI-LEEF	General practice adoption of GLI-LEEF as defined by the number of general practitioners that are willing to implement GLI-LEEF in this study	12 months
Primary	Lifestyle coach adoption of GLI-LEEF	Lifestyle coach adoption of GLI-LEEF as defined by the number of lifestyle coaches that are willing to implement GLI-LEEF in this study	12 months
Primary	Adherence to GLI-LEEF	First aspect of implementation is adherence to GLI-LEEF which is defined by the number of sessions attended by the participant out of the total of 18 sessions	18 weeks
Primary	Drop-out from GLI-LEEF	Second aspect of implementation is drop-out from GLI-LEEF which is defined by the proportion of participants who decide to prematurely stop taking part in the intervention	18 weeks
Primary	Barriers and facilitators of the GLI-LEEF implementation	Potential barriers and facilitators of the GLI-LEEF implementation will be identified using a qualitative approach by interviewing approximately 10 participants who dropped out and 10 who completed GLI-LEEF, if opportune	18 weeks
Secondary	Body weight of the participant as assessed by a medical weight scale	Body weight in kilograms	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
Secondary	Body height of the participant as assessed by a stadiometer	Body height in meters	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
Secondary	Waist circumference of the participant as assessed using a tape meter line	Waist circumference in centimeters	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
Secondary	Diastolic and systolic blood pressure as assessed using a sphygmomanometer	Diastolic and systolic blood pressure in millimeters mercury	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
Secondary	Treatment success on several domains by according to the Outcome Questionnaire-45 (OQ-=45)	The OQ-45 runs from 0 to 180. The lower the score, the more successful treatment	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
Secondary	Recovery of the participant according to the Individual Recovery Outcomes - Counter (I.ROC)	The I.ROC is an instrument to quantitatively measure recovery. The total score runs from 12 to 72. Higher scores indicate better outcomes.	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
Secondary	Wellbeing as assessed by the Mental Health Continuum Short Form (MHC-SF)	The MHC-SF measures emotional, social and psychological wellbeing. Its total score runs from 0 to 20. Higher score means better outcome.	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
Secondary	Self esteem according to the Rosenberg Self-Esteem Scale (RSES)	The RSES is a widely used self-report instrument for evaluating individual self-esteem. The total score runs from 0 to 30. Higher score means worse outcome, i.e. less self-esteem.	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
Secondary	Insomnia according to the Insomnia Severity Index (ISI)	The ISI assesses insomnia. The total score runs from 0 to 28. Higher score means worse outcome.	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
Secondary	Quality of life according to the Recovering Quality of Life (ReQol)	This is a Patient Reported Outcome Measure assesses the quality of life for people with different mental health conditions. Its score runs from 0 to 80. Higher score means better outcome.	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)
Secondary	Health care consumption and productivity loss according to the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)	The TiC - P assesses health care consumption and productivity loss in patients with mental illness	Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline)