Long-term Cancer Risk in the Randomised Oslo Diet and Antismoking Study
18. januar 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
1216
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 49 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Styring
Ingen indgriben
|
|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of the group of cancers related to smoking, diet or body mass index
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mortality in the group of cancers related to smoking, diet or body mass index
Tidsramme: 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
Tidsramme: 43 years
|
Any cancer diagnosis, drawn from the Cancer Registry of Norway
|
43 years
|
|
Cancer mortality
Tidsramme: 43 years
|
Mortality in any cancer, drawn from the Norwegian Cause of Death Registry
|
43 years
|
|
Incidence of gastrointestinal cancer
Tidsramme: 43 years
|
Diagnosis of carcinoma in gastro-intestinal tract, drawn from the Cancer Registry of Norway
|
43 years
|
|
Incidence of lung cancer
Tidsramme: 43 years
|
Diagnosis of carcinoma in lung, drawn from the Cancer Registry of Norway
|
43 years
|
|
Incidence of urinary tract cancer
Tidsramme: 43 years
|
Diagnosis of carcinoma in urinary tract, drawn from the Cancer Registry of Norway
|
43 years
|
|
Incidence of prostate cancer
Tidsramme: 43 years
|
Diagnosis of carcinoma in prostate, drawn from the Cancer Registry of Norway
|
43 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Paula Berstad, PhD, Cancer Registry of Norway
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. januar 1972
Primær færdiggørelse (Faktiske)
30. juni 2017
Studieafslutning (Faktiske)
30. september 2017
Datoer for studieregistrering
Først indsendt
8. januar 2018
Først indsendt, der opfyldte QC-kriterier
18. januar 2018
Først opslået (Faktiske)
25. januar 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. januar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. januar 2018
Sidst verificeret
1. januar 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2016/1442
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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