CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 177 enrolled
Drug / intervention
Lifestyle treatmentbehavioral
Likely dose
Not stated in record
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Search/NCT03157557
NCT03157557N/ACompleted

Multidisciplinary Lifestyle-enhancing Treatment for Long-term Severe Mentally Ill Inpatients: Sheltered Housing

GGZ Centraal·interventional·Posted May 17, 2017·Updated May 19, 2020

In Brief

A clinical study evaluating Lifestyle treatment for Lifestyle and Mental Disorders, Severe. Completed, enrolled 177 participants across 1 site.

Detailed 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. 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 17, 2017
Enrollment StartJul 19, 2017
Primary CompletionMar 1, 2020
Study CompletionMay 17, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.1 years ago

Interventions

Lifestyle treatmentbehavioral

Lifestyle treatment