Objectives:This research aims to develop an appropriate lifestyle intervention for patients living in sheltered housing services of GGz Central, based on input of patients and directly involved. Does applying this lifestyle treatment result in a…
ID
Source
Brief title
Condition
- Other condition
- Schizophrenia and other psychotic disorders
Synonym
Health condition
patienten met EPA(ernstige psychiatrische aandoeningen)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome:
The primary outcome measure is the increase in metabolic health after 6 months.
Secondary outcome
Secondary Outcome Measure:
- Metabolic Health:Lipids, Fastin Glucose (values in blood sample)
- Activity: measured 5 consecutive days with an accelerometer
- Quality of Life: measured by the EuroQol 5D and WHOQoL-Bref
Background summary
Introduction and rationale:
Unhealthy eating habits and lack of physical activity are risk factors for many
diseases (including metabolic syndrome) and contribute to a shortened lifespan
of 15-30 years in people with severe mental illness (SMI). Literature, mainly
including short-term hospitalized or outpatients, show strong positive effects
of activation on both physical and mental health. However, studies in long-term
care are limited. In recent years, implementation of a lifestyle enhancing
treatment intervention in clinical settings in GGz Centraal has demonstrated to
be effective. The question is whether this kind of lifestyle intervention in
sheltered housing is applicable and effective.
Study objective
Objectives:
This research aims to develop an appropriate lifestyle intervention for
patients living in sheltered housing services of GGz Central, based on input
of patients and directly involved. Does applying this lifestyle treatment
result in a positive effect in health and quality of life of patients and what
is the influence of contextual factors, personal- and disease characteristics?
Study design
Study design:
In this intervention study, we use an experimental design. Municipal locations
are paired based on the number of participants to generate equal cluster sizes.
These paired clusters are randomly allocated to the control or intervention arm
by means of a random number generator by an independant person (not involved in
this project). At the start of the lifestyle treatment patients in the
experimental and control group are invited to participate in the baseline
screening. After six months, following a post-test on all outcome measures.
Intervention
Treatment intervention:
The intervention in this study consists of formulating a lifestyle
intervention, by patients en directly involved. This plan is based on physical
activities, healthy nutrition/eating habits and psycho education on life style.
After formulation of the plan it wil be executed for a six month period.
Study burden and risks
There are no implications that lifestyle enhancing treatment is associated with
risks. Burdens in measuring activity with the accelerometer 5 consecutive days
are negligible.
Utrechtseweg 266
Amersfoort 3818 EW
NL
Utrechtseweg 266
Amersfoort 3818 EW
NL
Listed location countries
Age
Inclusion criteria
severe mentally ill patients living in sheltered housing facilities
Exclusion criteria
Incapacitated patients, without informed consent from their legal representative
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03157557 |
| CCMO | NL61552.075.17 |