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临床试验/NCT00350311
NCT00350311已完成2 期

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

The University of New South Wales8 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2007年2月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
43
试验地点
8
主要终点
Smoking Cessation

研究概览

简要总结

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.

详细描述

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%).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Smoking Cessation

Body Mass Index

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (8)

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