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

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.