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Tailored Written Lifestyle Feedback in Colorectal Cancer Screening

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03396029
Enrollment
3642
Registered
2018-01-10
Start date
2014-11-01
Completion date
2018-10-31
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Body Weight, Diet Habit, Lifestyle, Physical Activity, Smoking Cessation

Keywords

Lifestyle intervention, Diet, Smoking cessation, Physical activity, Alcohol, Body mass index, colorectal cancer screening, sigmoidoscopy

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.

Interventions

BEHAVIORALIndividually tailored lifestyle feedback

The written, standardized individually tailored lifestyle feedback includes feedback on consumption of fruit, berries and vegetables and alcohol, physical activity, smoking and body mass index.

The leaflet is The Norwegian Cancer Society's one-page information brochure on healthy lifestyle behaviours for low cancer risk, including non-smoking, healthy body weight, physical activity, diet, moderate alcohol consumption, moderate sun exposure etc.

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Masking description

A computer programme designed by the research team IT developer carried out the randomization. The recruitment and the contact between the investigators and the participants was mailed. There was no face-to-face contact.

Eligibility

Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
A questionnaire-based lifestyle scoreOne year; from pre-screening until one year afterA 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

MeasureTime frameDescription
Smoking statusOne year; from pre-screening until one year afterSelf-reported smoking status (smoking vs. non-smoking), assessed by a questionnaire
Alcohol consumptionOne year; from pre-screening until one year afterSelf-reported consumption of alcoholic beverages (glasses/week), assessed by a questionnaire
Physical activityOne year; from pre-screening until one year afterSelf-reported weekly time spent in physical activity (number of 30-minute activity sessions per week), assessed by a questionnaire
Consumption of fruit and vegetablesOne year; from pre-screening until one year afterSelf-reported consumption of fruit, berries and vegetables (servings per day), assessed by a questionnaire
Body weightOne year; from pre-screening until one year afterSelf-reported body weight (whole kilograms), assessed by a questionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026