PHYSICO-DSM-VR - Physical Co-morbidity, Poor Health Behaviour and Health Promotion in Verona Patients With Functional Psychoses: a Prevalence Study and a Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 325
- 试验地点
- 8
- 主要终点
- Change in the number of participants that comply with WHO recommendations on diet and/or exercise
研究概览
简要总结
The study evaluates the efficacy of health promotion strategies on diet and physical activity in patients with psychosis. Half of the participants will receive an intervention protocol based on education and behavioural change, while half will not receive it.
详细描述
Epidemiological studies investigating the mortality and physical health of mental patients have provided substantial evidence of an excess mortality and of a substantially higher prevalence of physical co-morbidity as compared to the general population. These findings have been related to a higher prevalence of risk factors like high blood pressure, high plasma cholesterol and obesity, unhealthy lifestyles, medication side-effects.
The number of clinical trials and intervention studies in this area is still scanty and their scientific strength is relatively modest. The present research project aims at implementing preventive strategies related to dietary habits and physical exercise, and studying their efficacy with a randomized controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICD-10 diagnosis of affective or non-affective functional psychosis (codes F20-22, F24, F25, F28-F31, F23.3, F33.3)
- •one or more contacts with the CMHS in the 3 months preceding the beginning of the recruitment
- •Age 18-65
排除标准
- •moderate or severe mental handicap (learning disability)
- •organic brain disorders
- •lack of capacity to consent to inclusion
- •subjects already involved in individual treatment related to diet and physical exercise
- •subjects deemed unable or unfit to participate in the proposed physical activities
结局指标
主要结局
Change in the number of participants that comply with WHO recommendations on diet and/or exercise
时间窗: baseline, month 1, month 2, month 3, month 4, month 5 and month 6
Following the criteria proposed by World Health Organization for a healthy lifestyle: at least 5 servings of fruit/vegetables per day and at least 30 minutes of moderate physical activity per day 5 days a week. Achieving at least one more criterion than baseline at follow up is considered a success.
次要结局
- Physical examination(baseline)
- Long term chronic disease inventory (items 2.1-2.24; MOD.ISTAT/IMF-8/B.04-05-ISTAT)(baseline)
- Change in glycemia(baseline and month 6)
- Change in HDL cholesterol(baseline and month 6)
- Change in blood pressure(baseline, month 1, month 2, month 3, month 4, month 5 and month 6)
- Change in pulses(baseline, month 1, month 2, month 3, month 4, month 5 and month 6)
- Change in Body Mass Index(baseline, month 1, month 2, month 3, month 4, month 5 and month 6)
- Change in waist circumference(baseline, month 1, month 2, month 3, month 4, month 5 and month 6)
- Change in haemoglobin A1C(baseline and month 6)
- Change in LDL cholesterol(baseline and month 6)
- Change in triglyceridemia(baseline and month 6)
- Electrocardiogram(baseline)
- 36 Item Short Form Health Survey(beginning and month 6)
- Medication History Schedule(baseline)
- Verona Service Satisfaction Scale - European Version(beginning and month 6)
研究者
Lorenzo Burti
Professor
Universita di Verona