About this trial
The goal of this study is to learn whether receiving personalized, digital lifestyle advice during colorectal cancer screening leeds to changes in lifestyle over a two-year follow-up period. Changes will be measured using a composite score including diet, alcohol consumption, physical activity, body mass index and smoking habits. The main questions it aims to answer are:
* Do participants who receive short, personalized digital feedback on their lifestyle - either once or through repeated rounds -change their lifestyle during the two-year study period, compared to those who do not receive any feedback? * Does the inclusion of additional contact, such as telephone consultation with healthcare providers, result in further lifestyle changes?
Researchers will compare three groups which receive digital feedback at different intensities and a control group which does not get any feedback to see if lifestyle changes differ between the groups.
Participants in four different groups will fill in a digital diet and lifestyle questionnaire at the start of the study and 2-4 times after this during the following 2 years.
* Participants in three of the groups will receive a short digital feedback report on their lifestyle related to health recommendations after each completion of the questionnaire. * One of these groups will also be offered to go through the feedback report together with a healthcare provider in a telephone call. * This group will also receive invitations to motivational webinars every half year during the 2-year study period. The topics in the webinars address cancer preventive lifestyle.
A secondary goal of the study is to understand whether the invitation to fill in the diet and lifestyle questionnaire affects participation in colorectal cancer screening. Therefore, a fifth group of individuals invited to colorectal cancer screening but not to be invited to fill in the questionnaire will be included for extra comparison. Participation in colorectal cancer screening will be compared between this group and the four groups that are additionally invited to complete the questionnaire.
Another secondary goal is to learn which groups in the society consent to the current study. Therefore, sociodemographic characteristics will be compared between the invited individuals who consent and those who do not consent to the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Invited to the first round of immunochemical faecal blood testing in the national colorectal cancer screening program via a digital platform.
Disqualifiers
Not invited to the national colorectal cancer screening program.
Trial design
Parallel
Treatments tested in this trial
Digikost report baseline only
BehavioralThe Digikost report will be made available for the participant immediately after completing of the Digikost questionnaire at baseline.
Digikost report intensive with individual counselling and webinars
BehavioralThe Digikost report will be made available for the participant each time after completion of the Digikost questionnaire every 6 months. Additionally, the participant is offered an individual lifestyle counselling meeting by telephone at baseline and invited to inspirational webinars on cancer preventive lifestyle every 6 months.
Digikost report intensive
BehavioralThe Digikost report will be made available for the participant each time after completion of the Digikost questionnaire every 6 months.
Treatment groups
Trial outcomes
Primary outcomes
Change in a healthy lifestyle score
Difference in a healthy lifestyle score, which consists of the 2018 WCRF/AICR Score added by smoking status for each participant, assessed at baseline and after the 2-year trial period. The healthy lifestyle score is a point score based on the participant's answers in the lifestyle questionnaire. 0-1 point is given for the grade to which the participant complies to each of the eight health recommendations: 1) normal body weight, 2) physical activity, 3) diet rich in wholegrains, vegetables, fruit and beans, 4) limited intake of 'fast foods' and other processed foods high in fat, starches or sugars, 5) limited consumption of red and processed meat, 6) limited consumption of sugar-sweetened drinks, 7) low alcohol consumption and 8) non-smoking. The healthy lifestyle score thus ranges from 0 (worst, meaning no compliance to health recommendations) to 8 points (best, meaning full compliance to health recommendations).
Secondary outcomes
Participation in colorectal cancer screening
Return of the faecal screening test sample to the laboratory in ColorectalScreen Norway. Participants receive status 1 if a faecal screening sample is registered at the laboratory, and 0 if a faecal screening sample is not registered at the laboratory.
Completion of the Digikost questionnaire at baseline
Participant invited to the trial registers him/herself at the digital study platform and fills in the first round Digikost questionnaire. Participants receive status 1 if completing, and 0 if not completing the questionnaire at baseline.
Long-term cancer incidence
Incidence of any cancer site registered in Cancer Registry after enrollment to the study. The outcome measure includes the ICD code of the diagnosis and the date of diagnosis.
Long-term cancer-specific mortality
Any cancer site as the death cause registered in Cancer Registry after enrollment to the study. The outcome measure includes the ICD code of the death cause and date of death.
Sponsors and contacts
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Norwegian Institute of Public Health
Lead sponsor
University of Oslo
Collaborator
Norwegian Cancer Society
Collaborator
This trial is not recruiting at the moment. You can still explore other options: