Pilot RCT on Lifestyles Impact on Health Outcomes in the General Population Invited to Mammography and Colorectal Cancer Screening Programmes. (STI.li di VI.ta - Lifestyles) STI.VI.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,270
- 试验地点
- 2
- 主要终点
- feasibility outcome
研究概览
简要总结
The main study objective is to determine the feasibility and impact (effectiveness) of intervention models for lifestyle changing (diet and physical activity) on health outcomes. Women 50 to 54-year-old attending the local breast cancer screening and 58-year-old people (both sexes) undergoing colorectal cancer screening are invited to participate in the study. Compliers are randomized into 3 intervention groups (Diet, Physical Activity, and Physical Activity and Diet) and into the 'usual care' Control group. Biological sampling (blood and saliva) is collected from all participants. All participants undergo also anthropometric measurements and fill in a self-administered validated questionnaire on their dietary and physical activity habits. All enrolled subjects receive a booklet with basic information about diet and physical activity. Subjects randomized to the 3 intervention groups are also offered one theoretical and three training courses. The courses are specifically designed for the different interventions proposed and aimed at reinforcing the educational counseling and at supporting behavioral changes.
Follow-up is performed at 8 (intermediate follow-up) and 12-14 (final follow-up) months for repeating anthropometric measurements and questionnaire filling and blood sampling (at the final one).
详细描述
The study aims to evaluate the effectiveness of intervention models on diet and physical activity.
The study randomizes eligible subjects into four groups: Diet group, Physical Activity group, Physical Activity and Diet group and "Usual Care" control group. To each group a specific intervention is delivered, consisting of counselling, informative material, and dedicated training.
All participants (with the exception of the control group) receive a basic counselling by field experts. Afterwards they are offered an advanced training including more specific and detailed actions.
An information booklet specifically developed for this study is distributed to all participants. The booklet contains general information on primary prevention, based on the most reliable and updated bibliographic sources on diet and physical exercise.
Together with the letter of screening invitation eligible men and women receive the proposal to participate in the STI.VI. study. Participation to screening is not considered a prerequisite for study participation. A direct phone number and e-mail address are given for extra information.
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
- 49 Years 至 61 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •49 to 55-year-old women invited to mammography screening,
- •58 to 61 year-old people (both sexes) invited to colorectal screening
排除标准
- •psychiatric disorders,
- •disabling disease
- •life expectancy <6 months
- •eating or deambulation disorders
- •in physiotherapy at the time of recruitment.
结局指标
主要结局
feasibility outcome
时间窗: 14 months
initial participation rate overall and stratified by intervention group, age, and gender;
impact of intervention model
时间窗: 14 months
compliance to lifestyle recommendations and their maintenance assessed through the STI.VI. questionnaire;
screening-related indicators
时间窗: up to 10 years after study end
screening participation rate in subjects enrolled in the STI.VI. study and, viceversa, STI.VI. participation rate in screened subjects;
次要结局
- Biobank implementation(up to 10 years after study end)
- Circulating biomarkers association with breast and colorectal cancer(up to 10 years after study end)
研究者
Nereo Segnan
Director, S.C. Epidemiologia, Screening e Registro Tumori Centre for Cancer Prevention, Principal investigator
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte