Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350311
Status:
COMPLETED
Last Update Posted:
2008-09-26
First Post:
2006-07-06
Brief Title:
Multicomponent Risk Factor Intervention for People With a Severe Mental Illness a Feasibility Study
Sponsor:
The University of New South Wales
Organization:
The University of New South Wales
Study Overview
Official Title:
Multicomponent Risk Factor Intervention for People With a Severe Mental Illness a Feasibility Study
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 cessationdietphysical 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
The proposed study will assess the feasibility of a multi-component behavioural intervention focussing on smoking cessationdietphysical 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None