A Randomized Trial of Tailored Written Lifestyle Feedback in Colorectal Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,642
- 主要终点
- A questionnaire-based lifestyle score
研究概览
简要总结
This randomized controlled trial aims to investigate the effect of an individually tailored lifestyle feedback letter and a leaflet on lifestyle in the context of sigmoidoscopy screening.
详细描述
Cancer screening may be used as a teachable moment for healthy lifestyle behaviours. This study aims to investigate the effect of minimal, but individually tailored lifestyle advice and a standard leaflet on healthy lifestyle given at a colorectal cancer screening context on one-year changes in these behaviours in a population-based sample of men and women.
Individuals invited to sigmoidoscopy screening in the piloting of Norwegian Bowel Cancer Screening are additionally invited to this lifestyle intervention study. Changes in lifestyle are measured by a brief lifestyle questionnaire administered at prescreening and after one year. The intervention to the intervention arms is given after completion of the prescreening lifestyle questionnaire.
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
- Single (Investigator)
盲法说明
A computer programme designed by the research team IT developer carried out the randomization. The recruitment and the contact between the investigators and the participants was mailed. There was no face-to-face contact.
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Invited to sigmoidoscopy screening in the Norwegian Bowel Cancer Screening Pilot Study
排除标准
- •Excluded from sigmoidoscopy screening due to medical reasons, previous colorectal cancer diagnosis, relocating out of the screening municipalities or previous colonoscopy in the last 12 months.
研究组 & 干预措施
Individually tailored lifestyle feedback
Written, standardized individually tailored lifestyle feedback based on participants responses to a lifestyle questionnaire, and a leaflet on healthy lifestyle mailed to the participant.
干预措施: Individually tailored lifestyle feedback (Behavioral)
Individually tailored lifestyle feedback
Written, standardized individually tailored lifestyle feedback based on participants responses to a lifestyle questionnaire, and a leaflet on healthy lifestyle mailed to the participant.
干预措施: Standard leaflet (Behavioral)
Standard leaflet
A leaflet on healthy lifestyle mailed to the participant.
干预措施: Standard leaflet (Behavioral)
Control
No contact with the participant.
结局指标
主要结局
A questionnaire-based lifestyle score
时间窗: One year; from pre-screening until one year after
A score variable ranging from 0 (least favorable) to 6 (most favorable), calculated as the sum of self-reported favorable lifestyle factors assessed by a questionnaire; non-smoking (1 score point), body mass index less than 25 kg/m2 (1 score point), a minimum of seven physical activity sessions of 30 minutes per a week (1 score point), a maximum of four dinner servings of red and processed meat per a week (1 score point), a minimum of three servings of fruit, berries and vegetables per a day (0.5 score point) and a minimum of one serving of fatty fish per a week (0.5 score points)
次要结局
- Smoking status(One year; from pre-screening until one year after)
- Body weight(One year; from pre-screening until one year after)
- Alcohol consumption(One year; from pre-screening until one year after)
- Physical activity(One year; from pre-screening until one year after)
- Consumption of fruit and vegetables(One year; from pre-screening until one year after)
研究者
Paula Berstad
Researcher
Oslo University Hospital