Multidisciplinary Lifestyle-enhancing Treatment for People With Severe Mental Illness in Sheltered Housing Facilities

May 17, 2020 updated by: GGZ Centraal

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

177

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Ermelo, Gelderland, Netherlands, 3853LC
        • Veldwijk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Severe Mentally Ill patients,
  • living in Sheltered Housing facilities

Exclusion Criteria:

  • Incapacitated patients,
  • without informed consent from their legal representative

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as Usual
Experimental: Lifestyle treatment
Behavioral: Lifestyle treatment
Lifestyle treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic Health: Waist circumference
Time Frame: 12 months
measured halfway between the iliac crest and lowest rib in standing position
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic Health: weight
Time Frame: 12 months
weight measured to the nearest 0.1kg
12 months
Metabolic Health: blood pressure
Time Frame: 12 months
measured systolic and diastolic blood pressure (mmHg)
12 months
Metabolic Health:Lipids
Time Frame: 12 months
values in blood sample
12 months
Metabolic Health:Fasting glucose
Time Frame: 12 months
values in blood sample
12 months
Metabolic health: HbA1c
Time Frame: 12 months
values in blood sample
12 months
Sedentary behaviour & physical activity
Time Frame: 12 months
measured 5 consecutive days with an accelerometer (ActiGraph GT3X+
12 months
Quality of Life EuroQol 5D
Time Frame: 12 months
measured by the EuroQol 5D (EQ-5D)
12 months
Quality of Life WHOQoL
Time Frame: 12 months
measured by the WHOQoL-Bref
12 months
Psychopathology BPRS-E
Time Frame: 12 months
Psychopathology / illness severity measured by the BPRS-E
12 months
Implementation fidelity
Time Frame: At follow-up (12 months)
A proxy for implementation fidelity using the 'descriptive norm' item of the Measurement Instrument for Determinants of Innovations
At follow-up (12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GGZ Centraal

Investigators

  • Study Director: Peter N van Harten, Prof. Dr., GGZ Centraal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2017

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

May 17, 2020

Study Registration Dates

First Submitted

May 8, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 17, 2017

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 17, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL61552.075.17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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