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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350311
• Other study ID #: 95/05
• Status: Completed
• Phase: Phase 2
• First received: July 6, 2006
• Last updated: September 25, 2008
• Start date: February 2007
• Est. completion date: April 2008

Study information

• Verified date: September 2008
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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.

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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behavior, Addictive
• Mental Disorders
• Obesity
• Psychotic Disorder
• Psychotic Disorders

Intervention

Drug:
• nicotine transdermal patch/lozenge

Locations

Country	Name	City	State
Australia	Department of Psychiatry, Monash University, The Alfred Hospital	Melbourne	Victoria
Australia	Mental Health Research Institute, University of Melbourne, Royal Melbourne Hospital	Melbourne	Victoria
Australia	Centre for Mental Health Studies, Univeristy Of Newcastle	Newcastle	New South Wales
Australia	School of Public Health and Community Medicine, University of New South Wales	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
The University of New South Wales	Australian Government Department of Health and Ageing

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Cessation
Primary	Body Mass Index