Skip to main content
OpenTrials
Completed

NCT Number: NCT03396029

Tailored Written Lifestyle Feedback in Colorectal Cancer Screening

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lifestyle Alcohol Drinking Behavior Behavior, Animal Body Weight Diet Habit Drinking Behavior Feeding Behavior Health Behavior Motor Activity Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms Smoking Cessation

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Individually tailored lifestyle feedback

Behavioral

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.

Standard leaflet

Behavioral

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.

Primary outcomes

  1. 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

  1. Smoking status

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

    Self-reported smoking status (smoking vs. non-smoking), assessed by a questionnaire

  2. Alcohol consumption

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

    Self-reported consumption of alcoholic beverages (glasses/week), assessed by a questionnaire

  3. Physical activity

    Time frame: 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

  4. Consumption of fruit and vegetables

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

    Self-reported consumption of fruit, berries and vegetables (servings per day), assessed by a questionnaire

  5. Body weight

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

    Self-reported body weight (whole kilograms), assessed by a questionnaire

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Jan 10, 2018
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.