Tailored Written Lifestyle Feedback in Colorectal Cancer Screening

Not Applicable

Completed

• Conditions: Physical Activity; Body Weight; Alcohol Drinking; Lifestyle; Diet Habit; Smoking Cessation
• Interventions: Behavioral: Standard leaflet; Behavioral: Individually tailored lifestyle feedback

• Registration Number: NCT03396029
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2014-11-01
• Primary Completion: 2016-10-30
• Study First Submitted: 2017-12-29
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-10
• Study Completion: 2018-10-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3642

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard leaflet	Standard leaflet	A leaflet on healthy lifestyle mailed to the participant.
Individually tailored lifestyle feedback	Individually tailored lifestyle feedback	Written, standardized individually tailored lifestyle feedback based on participants responses to a lifestyle questionnaire, and a leaflet on healthy lifestyle mailed to the participant.
Individually tailored lifestyle feedback	Standard leaflet	Written, standardized individually tailored lifestyle feedback based on participants responses to a lifestyle questionnaire, and a leaflet on healthy lifestyle mailed to the participant.

Primary Outcome Measures

Name	Time	Method
A questionnaire-based lifestyle score	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 Outcome Measures

Name	Time	Method
Smoking status	One year; from pre-screening until one year after	Self-reported smoking status (smoking vs. non-smoking), assessed by a questionnaire
Body weight	One year; from pre-screening until one year after	Self-reported body weight (whole kilograms), assessed by a questionnaire
Alcohol consumption	One year; from pre-screening until one year after	Self-reported consumption of alcoholic beverages (glasses/week), assessed by a questionnaire
Physical activity	One year; from pre-screening until one year after	Self-reported weekly time spent in physical activity (number of 30-minute activity sessions per week), assessed by a questionnaire
Consumption of fruit and vegetables	One year; from pre-screening until one year after	Self-reported consumption of fruit, berries and vegetables (servings per day), assessed by a questionnaire