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

January 18, 2018 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
No intervention
Diet and antismoking advice
Dietary and antismoking advice, aiming to reduce participant's risk of cardiovascular diseases
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of the group of cancers related to smoking, diet or body mass index
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality in the group of cancers related to smoking, diet or body mass index
Time Frame: 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
Time Frame: 43 years
Any cancer diagnosis, drawn from the Cancer Registry of Norway
43 years
Cancer mortality
Time Frame: 43 years
Mortality in any cancer, drawn from the Norwegian Cause of Death Registry
43 years
Incidence of gastrointestinal cancer
Time Frame: 43 years
Diagnosis of carcinoma in gastro-intestinal tract, drawn from the Cancer Registry of Norway
43 years
Incidence of lung cancer
Time Frame: 43 years
Diagnosis of carcinoma in lung, drawn from the Cancer Registry of Norway
43 years
Incidence of urinary tract cancer
Time Frame: 43 years
Diagnosis of carcinoma in urinary tract, drawn from the Cancer Registry of Norway
43 years
Incidence of prostate cancer
Time Frame: 43 years
Diagnosis of carcinoma in prostate, drawn from the Cancer Registry of Norway
43 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Paula Berstad, PhD, Cancer Registry of Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 1972

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

January 8, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (Actual)

January 25, 2018

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/1442

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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