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Lifestyle InterVEntion Study in General Practice: LIVES - GP

Lifestyle InterVEntion Study in General Practice: LIVES - GP - LIVES

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56076
Enrollment
50
Registered
2023-07-03
Start date
2023-10-26
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression

Interventions

The starting point is the CooL intervention recommended by the Dutch Healthcare Authority. This is complemented by innovations that can be assumed to make this GLI suitable for patients with depress
d) Increasing health knowledge and skills by adding *hands-on* practical lessons in buying and cooking healthy food: augmentation of the healthy food module). GL-LEEF is personalized based on speci

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Aged 18 years or older - 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 (>88cm (women) of >102cm (men)).

Exclusion criteria

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 - Unability to read and write

Design outcomes

Primary

MeasureTime frame
Our main study parameter is the feasibility of implementing and researching an MLI for depression in general practice using the following elements of the RE-AIM framework (Reach, Adoption and Implementation): - Reach of our intervention as defined by the absolute number, proportion, and representativeness of individuals who are willing to participate in out of those invited. Reach is considered sufficient if it appears at least 20%. Representativeness will be assessed by comparing demographic variables (age and gender) between those who participate and who do not. GPs will be asked to document reasons for not inviting eligible patients. Reasons of patients to refrain from participation will be documented as well. GPs will be instructed to perform these documentations completely anonymous. - Adoption is assessed as the representativeness and the participation rates (denominator those invited) of general practices, general practitioners, and life style coaches participating in this study. Sufficient adoption is defined as at least 20% participation of GPs. The former is assessed where applicable in terms of practice size, years of experience, and urban or rural location. Qualitative interviews among involved caregivers will be performed to obtain in depth information about barriers and facilitating factors in participating into this study and adopting GLI-LEEF. - Implementation is defined as both adherence and drop-out. Adherence to the lifestyle intervention GLI-LEEF is defined by the number of sessions attended by the participant out of the total of 18 sessions. Adherence to the assessment schedule is defined as the proportion of assessments completed, both at the measurement and the participant level; Drop-out from the GLI-LEEF intervention as defined by the proportion of participants who decide to prematurely stop taking part in the intervention. Sufficient adherence is defined as at least 50% of sessions attended, and at least 50% of ass

Secondary

MeasureTime frame
Our secondary research parameter concerns the variance of the outcome measures of mental health, lifestyle factors, functioning, recovery, well-being, sleep quality, self-esteem, quality of life, health care costs, anthropometry and blood pressure.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)