NCT03410641

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1972

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 1972

Completed
45.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

45.5 years

First QC Date

January 8, 2018

Last Update Submit

January 18, 2018

Conditions

CancerGastrointestinal CancerLung CancerUrinary Tract CancerProstate Cancer

Keywords

cancer riskrandomised trialinterventionsmoking cessationdietary interventionweight loss

Outcome Measures

Primary Outcomes (1)

  • Incidence of the group of cancers related to smoking, diet or body mass index

    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 Outcomes (7)

  • Mortality in the group of cancers related to smoking, diet or body mass index

    43 years

  • Cancer incidence

    43 years

  • Cancer mortality

    43 years

  • Incidence of gastrointestinal cancer

    43 years

  • Incidence of lung cancer

    43 years

  • +2 more secondary outcomes

Study Arms (2)

Diet and antismoking advice

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

Behavioral: Diet and antismoking advice

Control

No intervention

Interventions

Diet and antismoking adviceBEHAVIORAL

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.

Diet and antismoking advice

Eligibility Criteria

Age40 Years - 49 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NeoplasmsGastrointestinal NeoplasmsLung NeoplasmsUrologic NeoplasmsProstatic NeoplasmsSmoking CessationWeight Loss

Interventions

Diet

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrologic DiseasesGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesProstatic DiseasesHealth BehaviorBehaviorBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Paula Berstad, PhD

    Norwegian Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 25, 2018

Study Start

January 15, 1972

Primary Completion

June 30, 2017

Study Completion

September 30, 2017

Last Updated

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share