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

J Clin Psychiatry. 2014 May;75(5):498-505. doi: 10.4088/JCP.13m08503.

Abstract

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: ISRCTN22581937.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antipsychotic Agents / therapeutic use
  • Benzodiazepines / therapeutic use
  • Body Mass Index*
  • Clozapine / therapeutic use
  • Diet / methods
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Health Behavior*
  • Humans
  • Male
  • Motor Activity / physiology
  • Olanzapine
  • Pilot Projects
  • Psychiatric Status Rating Scales
  • Psychotherapy / methods*
  • Psychotic Disorders / drug therapy
  • Psychotic Disorders / therapy*
  • Single-Blind Method
  • Treatment Outcome
  • Young Adult

Substances

  • Antipsychotic Agents
  • Benzodiazepines
  • Clozapine
  • Olanzapine

Associated data

  • ISRCTN/ISRCTN22581937