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

NCT03157557 | Completed

• 1 other identifier: NL61552.075.17
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lifestyle; Mental Disorders, Severe

Keywords

Treatment; Sheltered Housing

Outcome Measures

Primary Outcomes (1)

• Metabolic Health: Waist circumference

  measured halfway between the iliac crest and lowest rib in standing position

  12 months

Secondary Outcomes (10)

• Metabolic Health: weight

  12 months

• Metabolic Health: blood pressure

  12 months

• Metabolic Health:Lipids

  12 months

• Metabolic Health:Fasting glucose

  12 months

• Metabolic health: HbA1c

  12 months

Study Arms (2)

Lifestyle treatment

EXPERIMENTAL

Lifestyle treatment

Behavioral: Lifestyle treatment

Treatment as Usual

NO INTERVENTION

Treatment as Usual

Interventions

Lifestyle treatment BEHAVIORAL

Lifestyle treatment

Lifestyle treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• GGZ Centraal: lead

Study Sites (1)

Veldwijk

Ermelo, Gelderland, 3853LC, Netherlands

Location

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  PMID: 36412504 DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Peter N van Harten, Prof. Dr.

  GGZ Centraal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 17, 2017
• Study Start: July 19, 2017
• Primary Completion: March 1, 2020
• Study Completion: May 17, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)