Long-term Cancer Risk in the Randomised Oslo Diet and Antismoking Study
2018年1月18日 更新者：Paula Berstad、Oslo University Hospital
The Effect of Lifestyle Intervention on the Risk of Cancer - A Study of Participants in the Oslo Diet and Antismoking Study
This study examines the effect of a five-year multifactorial lifestyle intervention in the Oslo diet and antismoking study on long-term cancer risk.
In 1972-1973, 1232 men with high cardiovascular risk profile were randomised to intervention including cholesterol lowering diet, weight loss and antismoking advice, or control (1:1).
This study examines the effect of the intervention on 43-year cancer incidence and mortality.
研究概览
详细说明
The Oslo diet and antismoking study showed that a 5-year lifestyle intervention reduced the long-term risk of coronary events and mortality. The lifestyle risk factors for cancer are partly similar to those for coronary heart disease, e.g. smoking, high body weight, unfavourable diet. The investigators therefore expect that the intervention has an effect on cancer risk in the long term.
In this follow-up study, the investigators analyse the association between the intervention, and cancer incidence and mortality drawn from the Cancer Registry of Norway and the Norwegian Cause of Death Registry from the time of randomisation in 1972/3 until the end of 2015.
研究类型
观察性的
注册 (实际的)
1216
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 49年 (成人)
接受健康志愿者
是的
有资格学习的性别
男性
取样方法
非概率样本
研究人群
The participants selected for this follow-up study (n=1216) are the eligible subjects of the 1232 men at high cardiovascular risk profile who participated in the Oslo Diet and Antismoking Study (included in 1972-73).
Fourteen men were excluded because they did not consent to studies other than the main study, and two more because of previous history of cancer.
描述
Inclusion Criteria:
- participated in screening of coronary risk factors, into which all men born in 1923-1932 and living in Oslo were invited in 1972-1973
- being in the upper quartile of a coronary risk score based on blood pressure, serum total cholesterol concentration and cigarette smoking
Exclusion Criteria:
- serum total cholesterol level above 9.0 mmol per Liter
- having a healthy diet, based on a short dietary history
- self-reported cardiovascular disease or diabetes
- previous history of cancer
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
控制
无干预
|
|
|
Diet and antismoking advice
Dietary and antismoking advice, aiming to reduce participant's risk of cardiovascular diseases
|
Dietary advice with the aim of reducing participant's serum cholesterol levels, including reduction in the intake of saturated fat and cholesterol, and increased intake of polyunsaturated fat, fish, vegetables and fruit.
Weight reduction was recommended for overweight men, as well as reduced consumption of sugar rich foods and drinks, and alcoholic beverages.
Smokers were advised to stop smoking.
The advice was given both individually and in group sessions during a five-year time period from 1972/3 until 1977/8.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of the group of cancers related to smoking, diet or body mass index
大体时间：43 years
|
Diagnosis of carcinoma in the oral cavity, oropharynx, esophagus, stomach, colorectum, liver and intrahepatic bile ducts, pancreas, larynx, trachea, bronchus and lung, urinary tract and thyroid gland, drawn from the Cancer Registry of Norway
|
43 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mortality in the group of cancers related to smoking, diet or body mass index
大体时间：43 years
|
Mortality in cancers in the oral cavity, oropharynx, esophagus, stomach, colorectum, liver and intrahepatic bile ducts, pancreas, larynx, trachea, bronchus and lung, urinary tract and thyroid gland, drawn from the Norwegian Cause of Death Registry
|
43 years
|
|
Cancer incidence
大体时间：43 years
|
Any cancer diagnosis, drawn from the Cancer Registry of Norway
|
43 years
|
|
Cancer mortality
大体时间：43 years
|
Mortality in any cancer, drawn from the Norwegian Cause of Death Registry
|
43 years
|
|
Incidence of gastrointestinal cancer
大体时间：43 years
|
Diagnosis of carcinoma in gastro-intestinal tract, drawn from the Cancer Registry of Norway
|
43 years
|
|
Incidence of lung cancer
大体时间：43 years
|
Diagnosis of carcinoma in lung, drawn from the Cancer Registry of Norway
|
43 years
|
|
Incidence of urinary tract cancer
大体时间：43 years
|
Diagnosis of carcinoma in urinary tract, drawn from the Cancer Registry of Norway
|
43 years
|
|
Incidence of prostate cancer
大体时间：43 years
|
Diagnosis of carcinoma in prostate, drawn from the Cancer Registry of Norway
|
43 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Paula Berstad, PhD、Cancer Registry of Norway
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
1972年1月15日
初级完成 (实际的)
2017年6月30日
研究完成 (实际的)
2017年9月30日
研究注册日期
首次提交
2018年1月8日
首先提交符合 QC 标准的
2018年1月18日
首次发布 (实际的)
2018年1月25日
研究记录更新
最后更新发布 (实际的)
2018年1月25日
上次提交的符合 QC 标准的更新
2018年1月18日
最后验证
2018年1月1日
更多信息
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