FOR-HEALTH: study protocol for a randomized controlled feasibility trial of Structured Health Dialogues to improve lifestyle habits and metabolic health in forensic psychiatric inpatients.
Mikael Vestlund, Veronica Milos Nymberg, Peter Andiné, Märta Wallinius
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引用次数: 0
Abstract
Background: People with severe mental illness demonstrate markedly reduced life expectancy, largely due to preventable cardiometabolic disease. This burden is particularly pronounced in compulsory forensic psychiatric care, where prolonged inpatient stays, restrictive environments, and long-term antipsychotic treatment contribute to high levels of sedentary behavior, unhealthy diet, tobacco use, and metabolic disturbances. Despite substantial cardiometabolic risk, individuals in forensic psychiatric settings are frequently excluded from preventive health research, resulting in limited evidence regarding the feasibility and acceptability of lifestyle interventions in this context. Recent international recommendations emphasize the need to integrate structured lifestyle interventions as core components of mental healthcare, including in secure and compulsory settings.
Objectives: The FOR-HEALTH study aims to assess the feasibility and acceptability of an adapted Structured Health Dialogue intervention delivered in compulsory forensic psychiatric inpatient care. Secondary objectives are to describe cardiometabolic, lifestyle, and patient-reported outcomes to inform the design of a future definitive randomized controlled trial.
Methods: This randomized controlled feasibility trial evaluates an adapted version of Structured Health Dialogues, an evidence-based cardiovascular prevention model originally developed for Swedish primary care. Participants are randomized in a 1:1 ratio to receive either Structured Health Dialogues plus treatment as usual or treatment as usual alone. Structured Health Dialogues integrate a systematic assessment of lifestyle behaviors, biological risk markers, psychosocial stress, and heredity into an individualized visual risk profile, which forms the basis for a motivational, person-centered dialogue. The intervention is adapted to the forensic psychiatric context and delivered within a secure inpatient setting. Primary outcomes relate to feasibility, including recruitment, retention, intervention delivery, and acceptability. Secondary outcomes include exploratory changes in lifestyle behaviors, cardiometabolic risk markers, and patient-reported outcomes. A total of 50 participants (25 per group) will be recruited. The study has been approved by the Swedish Ethical Review Authority. The findings are expected to inform the design and implementation of a future definitive randomized controlled trial evaluating Structured Health Dialogues in forensic psychiatric inpatient care.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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