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Open Access Study protocol

Health promotion intervention in mental health care: design and baseline findings of a cluster preference randomized controlled trial

Nick Verhaeghe1*, Jan De Maeseneer2, Lea Maes1, Cornelis Van Heeringen3, Veerle Bogaert1, Els Clays1, Dirk De Bacquer1 and Lieven Annemans14

Author Affiliations

1 Department of Public Health, Faculty of Medicine and Health Sciences, Ghent University, De Pintelaan 185, B-9000, Ghent, Belgium

2 Department of Family Medicine and Primary Health Care, Faculty of Medicine and Health Sciences, Ghent University, De Pintelaan 185, B-9000, Ghent, Belgium

3 Department of Psychiatry and Medical Psychology, Faculty of Medicine and Health Sciences, Ghent University, De Pintelaan 185, B-9000, Ghent, Belgium

4 Department of Medical Sociology, Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel, Laarbeeklaan 103, B-1090, Brussels, Belgium

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BMC Public Health 2012, 12:431  doi:10.1186/1471-2458-12-431

Published: 13 June 2012

Abstract

Background

Growing attention is given to the effects of health promotion programs targeting physical activity and healthy eating in individuals with mental disorders. The design of evaluation studies of public health interventions poses several problems and the current literature appears to provide only limited evidence on the effectiveness of such programs. The aim of the study is to examine the effectiveness and cost-effectiveness of a health promotion intervention targeting physical activity and healthy eating in individuals with mental disorders living in sheltered housing. In this paper, the design of the study and baseline findings are described.

Methods/design

The design consists of a cluster preference randomized controlled trial. All sheltered housing organisations in the Flanders region (Belgium) were asked if they were interested to participate in the study and if they were having a preference to serve as intervention or control group. Those without a preference were randomly assigned to the intervention or control group. Individuals in the intervention group receive a 10-week health promotion intervention above their treatment as usual. Outcome assessments occur at baseline, at 10 and at 36 weeks. The primary outcomes include body weight, Body Mass Index, waist circumference, and fat mass. Secondary outcomes consist of physical activity levels, eating habits, health-related quality of life and psychiatric symptom severity. Cost-effectiveness of the intervention will be examined by calculating the Cost-Effectiveness ratio and through economic modeling.Twenty-five sheltered housing organisations agreed to participate. On the individual level 324 patients were willing to participate, including 225 individuals in the intervention group and 99 individuals in the control group. At baseline, no statistical significant differences between the two groups were found for the primary outcome variables.

Discussion

This is the first trial evaluating both the effectiveness and cost-effectiveness of a health promotion intervention targeting physical activity and healthy eating in mental health care using a cluster preference randomized controlled design. The baseline characteristics already demonstrate the unhealthy condition of the study population.

Trial registration

This study is registered at clinicaltrials.gov – NCT 01336946

Keywords:
Health promotion; Intervention study; Physical activity; Eating habits; Mental health care