An Exploratory Randomized Controlled Study of a Healthy Living Intervention in Early Intervention Services for Psychosis

Abstract

People with psychosis often experience weight gain, which places them at risk of cardiovascular disease, diabetes, and early death. To determine the uptake, adherence, and clinical effectiveness of a healthy living intervention designed to reduce weight gain. An exploratory randomized controlled trial, comparing the intervention with treatment as usual (TAU) in 2 early intervention services for psychosis in England. DSM-IV classification was the diagnostic criteria used to assign the psychiatric diagnoses. The primary outcome was change in body mass index (BMI) from baseline to 12-month follow-up. The study was conducted between February 2009 and October 2012. 105 service users, with a BMI of ≥ 25 (≥ 24 in South Asians), were randomized to intervention (n = 54) or TAU (n = 51) after stratification by recent commencement of antipsychotic medication. Ninety-three service users (89%) were followed up at 12 months. Between-group difference in change in BMI was not significant (effect size = 0.11). The effect of the intervention was larger (effect size = 0.54, not significant) in 15 intervention (28%) and 10 TAU (20%) participants who were taking olanzapine or clozapine at randomization. The healthy living intervention did not show a significant difference in BMI reduction compared to the TAU group. www.isrctn.org identifier: ISRCTN22581937.