Long-term Cancer Risk in the Randomised Oslo Diet and Antismoking Study

NCT ID: NCT03410641

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1216 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1972-01-15
• Study Completion Date: 2017-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Cancer; Gastrointestinal Cancer; Lung Cancer; Urinary Tract Cancer; Prostate Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Diet and antismoking advice

Dietary and antismoking advice, aiming to reduce participant's risk of cardiovascular diseases

Diet and antismoking advice

Intervention Type: BEHAVIORAL

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.

Control

No intervention

No interventions assigned to this group

Interventions

Diet and antismoking advice

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paula Berstad

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paula Berstad, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian Institute of Public Health

Other Identifiers

2016/1442

Identifier Type: -

Identifier Source: org_study_id