Lifestyle InterVEntion Study in General Practice: LIVES - GP

NCT ID: NCT06286345

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-07-01

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 (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)

Conditions

Depression, Unipolar; Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GGZ Drenthe Mental Health Institution

UNKNOWN

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Medical Center Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Huibert Burger, MD PhD

Role: CONTACT

h.burger@umcg.nl

+31(0)50 361 6722 ext. 6722

Jolien A Panjer, MD

Role: CONTACT

j.a.panjer@umcg.nl

+31(0)50 361 6722 ext. 6722

Facility Contacts

Huibert Burger, MD PhD

Role: primary

h.burger@umcg.nl

+31(0)50 361 6722 ext. 6722

Patrick Brink

Role: backup

p.brink@umcg.nl

+31(0)50 361 6724 ext. 6724

Other Identifiers

17644

Identifier Type: -

Identifier Source: org_study_id