Long-term Cancer Risk in the Randomised Oslo Diet and Antismoking Study
18. januar 2018 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
1216
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 49 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Kontroll
Ingen inngrep
|
|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Paula Berstad, PhD, Cancer Registry of Norway
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. januar 1972
Primær fullføring (Faktiske)
30. juni 2017
Studiet fullført (Faktiske)
30. september 2017
Datoer for studieregistrering
Først innsendt
8. januar 2018
Først innsendt som oppfylte QC-kriteriene
18. januar 2018
Først lagt ut (Faktiske)
25. januar 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. januar 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. januar 2018
Sist bekreftet
1. januar 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2016/1442
Plan for individuelle deltakerdata (IPD)
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NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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Nei
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