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.


METHODS
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.


BACKGROUND
www.isrctn.org identifier: ISRCTN22581937.
School of Nursing, Midwifery and Social Work, Room 6.322a, Jean McFarlane Bldg, Oxford Rd, University of Manchester, Manchester, M13 9PL United Kingdom karina.lovell@manchester.ac.uk.
Karina
K
Lovell
Alison
A
Wearden
Tim
T
Bradshaw
Barbara
B
Tomenson
Rebecca
R
Pedley
Linda M
LM
Davies
Nusrat
N
Husain
Adrine
A
Woodham
Diane
D
Escott
Caroline M
CM
Swarbrick
Omolade
O
Femi-Ajao
Jeff
J
Warburton
Max
M
Marshall
D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use; D001569:Benzodiazepines / Q000627:therapeutic use; D015992:Body Mass Index; D003024:Clozapine / Q000627:therapeutic use; D004032:Diet / Q000379:methods; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D015438:Health Behavior; D006801:Humans; D008297:Male; D009043:Motor Activity / Q000502:physiology; D000077152:Olanzapine; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D011613:Psychotherapy / Q000379:methods*; D011618:Psychotic Disorders / Q000188:drug therapy / Q000628:therapy*; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult
D014150:Antipsychotic Agents; D001569:Benzodiazepines; D003024:Clozapine; D000077152:Olanzapine