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Clinical Trials/NCT03396029
NCT03396029
Completed
Not Applicable

A Randomized Trial of Tailored Written Lifestyle Feedback in Colorectal Cancer Screening

Oslo University Hospital0 sites3,642 target enrollmentNovember 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lifestyle
Sponsor
Oslo University Hospital
Enrollment
3642
Primary Endpoint
A questionnaire-based lifestyle score
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This randomized controlled trial aims to investigate the effect of an individually tailored lifestyle feedback letter and a leaflet on lifestyle in the context of sigmoidoscopy screening.

Detailed Description

Cancer screening may be used as a teachable moment for healthy lifestyle behaviours. This study aims to investigate the effect of minimal, but individually tailored lifestyle advice and a standard leaflet on healthy lifestyle given at a colorectal cancer screening context on one-year changes in these behaviours in a population-based sample of men and women. Individuals invited to sigmoidoscopy screening in the piloting of Norwegian Bowel Cancer Screening are additionally invited to this lifestyle intervention study. Changes in lifestyle are measured by a brief lifestyle questionnaire administered at prescreening and after one year. The intervention to the intervention arms is given after completion of the prescreening lifestyle questionnaire.

Registry
clinicaltrials.gov
Start Date
November 1, 2014
End Date
October 31, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Paula Berstad

Researcher

Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

  • Invited to sigmoidoscopy screening in the Norwegian Bowel Cancer Screening Pilot Study

Exclusion Criteria

  • Excluded from sigmoidoscopy screening due to medical reasons, previous colorectal cancer diagnosis, relocating out of the screening municipalities or previous colonoscopy in the last 12 months.

Outcomes

Primary Outcomes

A questionnaire-based lifestyle score

Time Frame: One year; from pre-screening until one year after

A score variable ranging from 0 (least favorable) to 6 (most favorable), calculated as the sum of self-reported favorable lifestyle factors assessed by a questionnaire; non-smoking (1 score point), body mass index less than 25 kg/m2 (1 score point), a minimum of seven physical activity sessions of 30 minutes per a week (1 score point), a maximum of four dinner servings of red and processed meat per a week (1 score point), a minimum of three servings of fruit, berries and vegetables per a day (0.5 score point) and a minimum of one serving of fatty fish per a week (0.5 score points)

Secondary Outcomes

  • Smoking status(One year; from pre-screening until one year after)
  • Body weight(One year; from pre-screening until one year after)
  • Alcohol consumption(One year; from pre-screening until one year after)
  • Physical activity(One year; from pre-screening until one year after)
  • Consumption of fruit and vegetables(One year; from pre-screening until one year after)

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