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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00350311
Enrollment
43
Registered
2006-07-10
Start date
2007-02-28
Completion date
2008-04-30
Last updated
2008-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior, Addictive, Obesity, Psychotic Disorder

Brief 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.

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%).

Interventions

DRUGnicotine transdermal patch/lozenge

Sponsors

Australian Government Department of Health and Ageing
CollaboratorOTHER_GOV
The University of New South Wales
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Smoking Cessation
Body Mass Index

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026