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An Exploratory Randomized Controlled Study of a Healthy Living Intervention in Early Intervention Services for Psychosis: the INTERvention to Encourage ACTivity, Improve Diet, and Reduce Weight Gain (INTERACT) Study
Background: People with psychosis often experience weight gain, which places them at risk of cardiovascular disease, diabetes, and early death.
Objective: To determine the uptake, adherence, and clinical effectiveness of a healthy living intervention designed to reduce weight gain.
Method: 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.
Results: 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.
Conclusions: The healthy living intervention did not show a significant difference in BMI reduction compared to the TAU group.
Trial Registration: www.isrctn.org identifier:
J Clin Psychiatry
© Copyright 2014 Physicians Postgraduate Press, Inc.
Submitted: March 29, 2013; accepted September 19, 2013.
Online ahead of print: January 21, 2014 (doi:10.4088/JCP.13m08503).
Corresponding author: Karina Lovell, PhD, School of Nursing, Midwifery and Social Work, Room 6.322a, Jean McFarlane Bldg, Oxford Rd, University of Manchester, Manchester, M13 9PL United Kingdom (firstname.lastname@example.org).