Health promotion in individuals with mental disorders: a cluster preference randomized controlled trial

BACKGROUND: The existing literature on weight management interventions targeting physical activity and healthy eating in mental health care appears to provide only limited evidence. The aim of the study was to examine the effectiveness of a 10-week health promotion intervention, followed by a 6-month follow-up period in individuals with mental disorders living in sheltered housing in the Flanders region (Belgium). METHODS: The study had a cluster preference randomized controlled design. Twenty-five sheltered housing organisations agreed to participate (16 in the intervention group, nine in the control group). In the intervention group, 225 individuals agreed to participate, while in the control group 99 individuals entered into the study. The main outcomes were changes in body weight, Body Mass Index, waist circumference and fat mass. Secondary outcomes consisted of changes in physical activity levels, eating habits, health-related quality of life and psychiatric symptom severity. RESULTS: A significant difference was found between the intervention group and the control group regarding body weight (−0.35 vs. +0.22 kg; p=0.04), Body Mass Index (−0.12 vs. +0.08 kg/m(2); p=0.04), waist circumference (−0.29 vs. + 0.55 cm; p<0.01), and fat mass (−0.99 vs. −0.12%; p<0.01). The decrease in these outcomes in the intervention group disappeared during the follow up period, except for fat mass. Within the intervention group, a larger decrease in the primary outcomes was found in the participants who completed the intervention. No significant differences between the two groups in changes in the secondary outcomes were found, except for the pedometer-determined steps/day. In the intervention group, the mean number of daily steps increased, while it decreased in the control group. CONCLUSIONS: The study demonstrated that small significant improvements in the primary outcomes are possible in individuals with mental disorders. Integration of health promotion activities targeting physical activity and healthy eating into daily care are, however, necessary to maintain the promising results. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov NCT 01336946