LifestyleNCT03157557
Multidisciplinary Lifestyle-enhancing Treatment for People With Severe Mental Illness in Sheltered Housing Facilities
A study testing Lifestyle treatment in people with Lifestyle and Mental Disorders, Severe, run by GGZ Centraal at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lifestyle, Mental Disorders, Severe
- What is being tested?
- Lifestyle treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Jul 2017to 17 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe Mentally Ill patients,
- living in Sheltered Housing facilities
Who cannot join
- Incapacitated patients,
- without informed consent from their legal representative
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multidisciplinary Lifestyle-enhancing Treatment for Long-term Severe Mentally Ill Inpatients: Sheltered Housing
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.
Read more
Objectives:
This research aims to develop an appropriate lifestyle intervention for patients living in sheltered housing services of GGz Centraal, 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:
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 independent 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 twelve months, following a post-test on all outcome measures.
Treatment intervention:
The intervention in this study consists of formulating a lifestyle intervention, by patients and directly involved, aimed at enhancing a more active and healthier lifestyle . After formulation of the plan (based on psycho education, nutrition and physical activity), it wil be executed for a twelve month period.
Hypothesis:
Hypotheses is that lifestyle enhancing treatment is associated with improved metabolic health, quality of life and reduced use of medication. Furthermore we expect that movement disorders and disease severity will be negative related in becoming more active.
Read the detailed description
Sample size calculation:
To calculate the sample size we use the effect size on decrease in waist circumference in the previous intervention study (d =0.51) and the same analysis (multiple regression with correction for baseline value's on age, diagnosis and disease severity). To be able to detect the same effect in the current study with a minimum 80% power as a benchmark for a fair test and a significant level of 95% (α = 0.05), a minimum sample of 124 people is required (2 groups of 62). Taking into account a response rate of 73% from the first measurement a sample size of 168 patients is required.
Analyses:
We use multilevel regression to analyze the intervention effect. Possible clustering of data within the residential locations (and thus care teams) is taken into account by using a two-level structure with the first level residential location and the patients as the second. The intervention variable is set as an independent variable against difference scores of outcome variables (T2 minus T1) and corrected for the baseline value of the outcome to prevent regression to the centre. As we are unable to randomize patients individually in the current configuration on personal and disease characteristics (gender, age, diagnosis, disease severity at the start of intervention), these factors will be corrected for in the analyses if they differ significantly(p<0.05) between intervention and control group, analysed using independent t-tests and chi-squared tests. Characteristics that differ significantly will be included as covariates in the analysis described above. Multicollinearity will be checked with correlation coefficients and collinearity statistics (tolerance and Variance Inflation Factors (VIF) values).
Missing data:
Patients who are hospitalized for more than two months will be excluded from analyses.
If baseline or follow-up data are missing for two or more measures on physical or psychiatric health, patients are excluded from the analysis as insufficient difference scores can be calculated. Patients lacking difference scores on one outcome variable, are excluded from the analysis of that particular variable.
- Conditions
- Lifestyle, Mental Disorders, Severe
- Being tested
- Lifestyle treatment
- Keywords
- Treatment, Sheltered Housing
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle treatmentBehavioural
Lifestyle treatment
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle treatment | Experimental | Lifestyle treatment Receives: Behavioral: Lifestyle treatment |
| Treatment as Usual | No intervention | Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Health: Waist circumference
measured halfway between the iliac crest and lowest rib in standing position
Measured: 12 months
Secondary outcomes (10)
Metabolic Health: weight
weight measured to the nearest 0.1kg
Measured: 12 months
Metabolic Health: blood pressure
measured systolic and diastolic blood pressure (mmHg)
Measured: 12 months
Metabolic Health:Lipids
values in blood sample
Measured: 12 months
Metabolic Health:Fasting glucose
values in blood sample
Measured: 12 months
Metabolic health: HbA1c
values in blood sample
Measured: 12 months
Sedentary behaviour & physical activity
measured 5 consecutive days with an accelerometer (ActiGraph GT3X+
Measured: 12 months
Quality of Life EuroQol 5D
measured by the EuroQol 5D (EQ-5D)
Measured: 12 months
Quality of Life WHOQoL
measured by the WHOQoL-Bref
Measured: 12 months
Psychopathology BPRS-E
Psychopathology / illness severity measured by the BPRS-E
Measured: 12 months
Implementation fidelity
A proxy for implementation fidelity using the 'descriptive norm' item of the Measurement Instrument for Determinants of Innovations
Measured: At follow-up (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start19 Jul 2017
- Primary completion1 Mar 2020
- Study completion17 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- GGZ Centraal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter N van Harten, Prof. Dr., Study director, GGZ Centraal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157557
- Sponsor's protocol ID
- NL61552.075.17
- Status last verified
- May 2020
- First submitted
- 8 May 2017
- Last updated
- 19 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Acil AA, Dogan S, Dogan O. The effects of physical exercises to mental state and quality of life in patients with schizophrenia. J Psychiatr Ment Health Nurs. 2008 Dec;15(10):808-15. doi: 10.1111/j.1365-2850.2008.01317.x.
PubMed 19012672Aleman A, Hijman R, de Haan EH, Kahn RS. Memory impairment in schizophrenia: a meta-analysis. Am J Psychiatry. 1999 Sep;156(9):1358-66. doi: 10.1176/ajp.156.9.1358.
PubMed 10484945Andreasen NC, Carpenter WT Jr, Kane JM, Lasser RA, Marder SR, Weinberger DR. Remission in schizophrenia: proposed criteria and rationale for consensus. Am J Psychiatry. 2005 Mar;162(3):441-9. doi: 10.1176/appi.ajp.162.3.441.
PubMed 15741458Bassett DR Jr, Cureton AL, Ainsworth BE. Measurement of daily walking distance-questionnaire versus pedometer. Med Sci Sports Exerc. 2000 May;32(5):1018-23. doi: 10.1097/00005768-200005000-00021.
PubMed 10795795Bech P, Larsen JK, Andersen J. The BPRS: psychometric developments. Psychopharmacol Bull. 1988;24(1):118-21. No abstract available.
PubMed 3387515Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
PubMed 20526405Callaghan P. Exercise: a neglected intervention in mental health care? J Psychiatr Ment Health Nurs. 2004 Aug;11(4):476-83. doi: 10.1111/j.1365-2850.2004.00751.x.
PubMed 15255923Daumit GL, Goldberg RW, Anthony C, Dickerson F, Brown CH, Kreyenbuhl J, Wohlheiter K, Dixon LB. Physical activity patterns in adults with severe mental illness. J Nerv Ment Dis. 2005 Oct;193(10):641-6. doi: 10.1097/01.nmd.0000180737.85895.60.
PubMed 16208158Delespaul PH; de consensusgroep EPA. [Consensus regarding the definition of persons with severe mental illness and the number of such persons in the Netherlands]. Tijdschr Psychiatr. 2013;55(6):427-38. Dutch.
PubMed 23864410Dingemans PM, Linszen DH, Lenior ME, Smeets RM. Component structure of the expanded Brief Psychiatric Rating Scale (BPRS-E). Psychopharmacology (Berl). 1995 Dec;122(3):263-7. doi: 10.1007/BF02246547.
PubMed 8748395Docx L, Sabbe BG, Koning J, Mentzel TQ, van Harten PN, Morrens M. [Instrumental registration of psychomotor symptoms in schizophrenia: has the time come to use the technique in clinical practice?]. Tijdschr Psychiatr. 2015;57(2):148-53. Dutch.
PubMed 25669955Farnam CR, Zipple AM, Tyrrell W, Chittinanda P. Health status risk factors of people with severe and persistent mental illness. J Psychosoc Nurs Ment Health Serv. 1999 Jun;37(6):16-21. doi: 10.3928/0279-3695-19990601-15.
PubMed 10382153Foussias G, Remington G. Negative symptoms in schizophrenia: avolition and Occam's razor. Schizophr Bull. 2010 Mar;36(2):359-69. doi: 10.1093/schbul/sbn094. Epub 2008 Jul 21.
PubMed 18644851Gerlach J, Korsgaard S, Clemmesen P, Lauersen AM, Magelund G, Noring U, Povlsen UJ, Bech P, Casey DE. The St. Hans Rating Scale for extrapyramidal syndromes: reliability and validity. Acta Psychiatr Scand. 1993 Apr;87(4):244-52. doi: 10.1111/j.1600-0447.1993.tb03366.x.
PubMed 8098178Hafkenscheid A. Psychometric evaluation of the Nurses Observation Scale for Inpatient Evaluation in The Netherlands. Acta Psychiatr Scand. 1991 Jan;83(1):46-52. doi: 10.1111/j.1600-0447.1991.tb05510.x.
PubMed 2011956
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Lifestyle-enhancing Treatment for Long-term Severe Mentally Ill Inpatients: Sheltered Housing
- ClinicalTrials.gov ID
- NCT03157557
- Acronym / sponsor ID
- NL61552.075.17
- Conditions
- Lifestyle, Mental Disorders, Severe
- Keywords
- Treatment, Sheltered Housing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- GGZ CentraalUniversity, hospital or other
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 17 May 2020 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Objectives:
This research aims to develop an appropriate lifestyle intervention for patients living in sheltered housing services of GGz Centraal, 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:
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 independent 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 twelve months, following a post-test on all outcome measures.
Treatment intervention:
The intervention in this study consists of formulating a lifestyle intervention, by patients and directly involved, aimed at enhancing a more active and healthier lifestyle . After formulation of the plan (based on psycho education, nutrition and physical activity), it wil be executed for a twelve month period.
Hypothesis:
Hypotheses is that lifestyle enhancing treatment is associated with improved metabolic health, quality of life and reduced use of medication. Furthermore we expect that movement disorders and disease severity will be negative related in becoming more active.
Detailed description
Sample size calculation:
To calculate the sample size we use the effect size on decrease in waist circumference in the previous intervention study (d =0.51) and the same analysis (multiple regression with correction for baseline value's on age, diagnosis and disease severity). To be able to detect the same effect in the current study with a minimum 80% power as a benchmark for a fair test and a significant level of 95% (α = 0.05), a minimum sample of 124 people is required (2 groups of 62). Taking into account a response rate of 73% from the first measurement a sample size of 168 patients is required.
Analyses:
We use multilevel regression to analyze the intervention effect. Possible clustering of data within the residential locations (and thus care teams) is taken into account by using a two-level structure with the first level residential location and the patients as the second. The intervention variable is set as an independent variable against difference scores of outcome variables (T2 minus T1) and corrected for the baseline value of the outcome to prevent regression to the centre. As we are unable to randomize patients individually in the current configuration on personal and disease characteristics (gender, age, diagnosis, disease severity at the start of intervention), these factors will be corrected for in the analyses if they differ significantly(p<0.05) between intervention and control group, analysed using independent t-tests and chi-squared tests. Characteristics that differ significantly will be included as covariates in the analysis described above. Multicollinearity will be checked with correlation coefficients and collinearity statistics (tolerance and Variance Inflation Factors (VIF) values).
Missing data:
Patients who are hospitalized for more than two months will be excluded from analyses.
If baseline or follow-up data are missing for two or more measures on physical or psychiatric health, patients are excluded from the analysis as insufficient difference scores can be calculated. Patients lacking difference scores on one outcome variable, are excluded from the analysis of that particular variable.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle treatment | Experimental | Behavioral: Lifestyle treatmentLifestyle treatment |
| Treatment as Usual | No intervention | –Treatment as Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Severe Mentally Ill patients,
- living in Sheltered Housing facilities
Key exclusion criteria (2 listed)
- Incapacitated patients,
- without informed consent from their legal representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle treatmentLifestyle treatment | Behavioural | Lifestyle treatment |
Primary outcome
Metabolic Health: Waist circumference
Time frame: 12 months
measured halfway between the iliac crest and lowest rib in standing position
10 secondary outcomes
Metabolic Health: weight
Time frame: 12 months
Metabolic Health: blood pressure
Time frame: 12 months
Metabolic Health:Lipids
Time frame: 12 months
Metabolic Health:Fasting glucose
Time frame: 12 months
Metabolic health: HbA1c
Time frame: 12 months
Sedentary behaviour & physical activity
Time frame: 12 months
Quality of Life EuroQol 5D
Time frame: 12 months
Quality of Life WHOQoL
Time frame: 12 months
Psychopathology BPRS-E
Time frame: 12 months
Implementation fidelity
Time frame: At follow-up (12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Background: PubMed 19012672Acil AA, Dogan S, Dogan O. The effects of physical exercises to mental state and quality of life in patients with schizophrenia. J Psychiatr Ment Health Nurs. 2008 Dec;15(10):808-15. doi: 10.1111/j.1365-2850.2008.01317.x.
- Background: PubMed 10484945Aleman A, Hijman R, de Haan EH, Kahn RS. Memory impairment in schizophrenia: a meta-analysis. Am J Psychiatry. 1999 Sep;156(9):1358-66. doi: 10.1176/ajp.156.9.1358.
- Background: PubMed 15741458Andreasen NC, Carpenter WT Jr, Kane JM, Lasser RA, Marder SR, Weinberger DR. Remission in schizophrenia: proposed criteria and rationale for consensus. Am J Psychiatry. 2005 Mar;162(3):441-9. doi: 10.1176/appi.ajp.162.3.441.
- Background: PubMed 10795795Bassett DR Jr, Cureton AL, Ainsworth BE. Measurement of daily walking distance-questionnaire versus pedometer. Med Sci Sports Exerc. 2000 May;32(5):1018-23. doi: 10.1097/00005768-200005000-00021.
- Background: PubMed 3387515Bech P, Larsen JK, Andersen J. The BPRS: psychometric developments. Psychopharmacol Bull. 1988;24(1):118-21. No abstract available.
- Background: PubMed 20526405Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
- Background: PubMed 15255923Callaghan P. Exercise: a neglected intervention in mental health care? J Psychiatr Ment Health Nurs. 2004 Aug;11(4):476-83. doi: 10.1111/j.1365-2850.2004.00751.x.
- Background: PubMed 16208158Daumit GL, Goldberg RW, Anthony C, Dickerson F, Brown CH, Kreyenbuhl J, Wohlheiter K, Dixon LB. Physical activity patterns in adults with severe mental illness. J Nerv Ment Dis. 2005 Oct;193(10):641-6. doi: 10.1097/01.nmd.0000180737.85895.60.
- Background: PubMed 23864410Delespaul PH; de consensusgroep EPA. [Consensus regarding the definition of persons with severe mental illness and the number of such persons in the Netherlands]. Tijdschr Psychiatr. 2013;55(6):427-38. Dutch.
- Background: PubMed 8748395Dingemans PM, Linszen DH, Lenior ME, Smeets RM. Component structure of the expanded Brief Psychiatric Rating Scale (BPRS-E). Psychopharmacology (Berl). 1995 Dec;122(3):263-7. doi: 10.1007/BF02246547.
- Background: PubMed 25669955Docx L, Sabbe BG, Koning J, Mentzel TQ, van Harten PN, Morrens M. [Instrumental registration of psychomotor symptoms in schizophrenia: has the time come to use the technique in clinical practice?]. Tijdschr Psychiatr. 2015;57(2):148-53. Dutch.
- Background: PubMed 10382153Farnam CR, Zipple AM, Tyrrell W, Chittinanda P. Health status risk factors of people with severe and persistent mental illness. J Psychosoc Nurs Ment Health Serv. 1999 Jun;37(6):16-21. doi: 10.3928/0279-3695-19990601-15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter N van Harten, Prof. Dr. study director
GGZ Centraal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle treatment in people with Lifestyle and Mental Disorders, Severe, run by GGZ Centraal at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Health: Waist circumference (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03157557, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.