Multicomponent Risk Factor Intervention for People With a Severe Mental Illness: a Feasibility Study

This study has been completed.
Sponsor:
Collaborator:
Australian Government Department of Health and Ageing
Information provided by:
The University of New South Wales
ClinicalTrials.gov Identifier:
NCT00350311
First received: July 6, 2006
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

This study is a feasibility study of a multi-component intervention to enhance healthy living among young people with psychotic disorders, specifically targeting smoking and weight.


Condition Intervention Phase
Psychotic Disorder
Obesity
Behavior, Addictive
Drug: nicotine transdermal patch/lozenge
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicomponent Risk Factor Intervention for People With a Severe Mental Illness: a Feasibility Study

Resource links provided by NLM:


Further study details as provided by The University of New South Wales:

Primary Outcome Measures:
  • Smoking Cessation
  • Body Mass Index

Enrollment: 43
Study Start Date: February 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Detailed Description:

We propose a feasibility study of a multi-component intervention to enhance healthy living among young people (18 to 40 years) with psychotic disorders, specifically targeting smoking and weight. Smoking is very common amongst people with psychotic disorders (around 70% of males, and over 50% of females) and this adds to the overall cardiovascular risk for this group. Obesity is also a common problem for people with psychosis, with an estimated 40-60% being obese or overweight. Obesity in this population may contribute to adverse medical and psychological consequences. For many obese people, targeted pharmacotherapy in addition to diet and increased physical activity can assist in both weight reduction and the maintenance of gains. Similarly, smoking cessation is enhanced by use of adjunctive medications such as nicotine replacement; such strategies continue to produce abstinence rates for up to 10 years.

The proposed study will assess the feasibility of a multi-component behavioural intervention focussing on smoking cessation/diet/physical activity.

The primary outcome measures from the feasibility study are smoking cessation and reduction in body mass index (BMI). Secondary outcomes will include tolerability and safety, as well as the impact the package has on other cardiovascular risk factors including serum lipids, blood sugar levels and depression in young people with psychosis. We will also establish whether smoking cessation and reduction in obesity is correlated with gains in terms of body image, quality and enjoyment of life and reduction in depression. Based on published data, behavioural interventions for smoking cessation and diet and physical activity lead smoking cessation in 20% of people at 12 months and to modest weight loss (around 5%).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-40 yrs
  • DSM-IV diagnosis of non-organic psychotic illness
  • Obesity (BMI > 30 or 27 if co-morbidities such as diabetes, hypertension or dyslipidaemia are present
  • Current smoker ( > 15 cigarettes per day) if also smoking cannabis regularly, they will still be able to participate

Exclusion Criteria:

  • Medical contraindication to exercise or use of the nicotine patch
  • Intellectual disability that would significantly impair ability to participate in the program
  • Inability to give informed consent (acutely psychotic potential participants will be reassessed one month post screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350311

Locations
Australia, New South Wales
Centre for Mental Health Studies, Univeristy Of Newcastle
Newcastle, New South Wales, Australia, 2308
School of Public Health and Community Medicine, University of New South Wales
Sydney, New South Wales, Australia, 2052
Australia, Victoria
Mental Health Research Institute, University of Melbourne, Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3004
Department of Psychiatry, Monash University, The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
The University of New South Wales
Australian Government Department of Health and Ageing
Investigators
Principal Investigator: Amanda Baker, Assoc Prof Centre for Mental Health Studies, Uni of Newcastle
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00350311     History of Changes
Other Study ID Numbers: 95/05
Study First Received: July 6, 2006
Last Updated: September 25, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Mental Disorders
Obesity
Psychotic Disorders
Behavior, Addictive
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Compulsive Behavior
Impulsive Behavior
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014