Targeting Lifestyle to Improve Colorectal Cancer Screening

NCT07135115 | Not Yet Recruiting DMC

• 2 other identifiers: 572721223165
• Study Type: interventional
• Target: 16,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lifestyle Alteration; Tobacco; Diet Modification; Physical Activity; Alcohol Consumption; Body Weight Control

Keywords

Lifestyle intervention; Colorectal cancer screening; Diet; Alcohol consumption; Smoking; Body mass index; Physical activity; Digital questionnaire

Outcome Measures

Primary Outcomes (1)

• 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).

  From baseline to the end of intervention at 24 months

Secondary Outcomes (9)

• Participation in colorectal cancer screening

  Within 6 months after sending of the faecal screening test kit to the participant at first screening round

• Completion of the Digikost questionnaire at baseline

  Within 3 months after receiving the invitation to the study

• Long-term cancer incidence

  From enrollment to the end of follow-up at 16 years

• Long-term cancer-specific mortality

  From enrollment to the end of follow-up at 16 years

• Long-term total mortality

  From enrollment to the end of follow-up at 16 years

Study Arms (5)

Lifestyle advice, low intensity

EXPERIMENTAL

The participants will receive digital personally tailored diet and lifestyle advice (the Digikost report) after completion of the Digikost questionnaire at baseline.

Behavioral: Digikost report baseline only

Lifestyle advice, medium intensity

EXPERIMENTAL

The participants will receive digital personally tailored diet and lifestyle advice (the Digikost report) after completion of the Digikost questionnaire at baseline and after each 6 months through the 2-year intervention period.

Behavioral: Digikost report intensive

Lifestyle advice, high intensity

EXPERIMENTAL

The participants will receive digital personally tailored diet and lifestyle advice (the Digikost report) after completion of the Digikost questionnaire at baseline and after each 6 months through the 2-year intervention period. Additionally, the participants will be offered an individual telephone counselling meeting on his/her Digikost report with an advisor at baseline, as well as invited to inspirational webinars on cancer preventive lifestyle every 6 months.

Behavioral: Digikost report intensive with individual counselling and webinars

Control

NO INTERVENTION

The participants will be invited to complete the Digikost questionnaire at baseline and after 6 months and 2 years, but will not receive the Digikost report after completing the questionnaire.

Usual care

NO INTERVENTION

Participants will be treated only with the current standard of practice in ColorectalScreen Norway. Participants will not be informed of the trial, invited to fill in the Digikost questionnaire or receive the Digikost report.

Interventions

Digikost report baseline only BEHAVIORAL

The Digikost report will be made available for the participant immediately after completing of the Digikost questionnaire at baseline.

Lifestyle advice, low intensity

Digikost report intensive with individual counselling and webinars BEHAVIORAL

The 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.

Lifestyle advice, high intensity

Digikost report intensive BEHAVIORAL

The Digikost report will be made available for the participant each time after completion of the Digikost questionnaire every 6 months.

Lifestyle advice, medium intensity

Eligibility Criteria

• Age: 55 Years - 56 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Invited to the first round of immunochemical faecal blood testing in the national colorectal cancer screening program via a digital platform.

You may not qualify if:

• Not invited to the national colorectal cancer screening program.

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead
• University of Oslo: collaborator
• Norwegian Cancer Society: collaborator

Study Sites (1)

Norwegian Institute of Public Health

Oslo, 0379, Norway

Location

Related Links

• Website for the project at University of Oslo
• Website for the project at the Norwegian Institute of Public Health

MeSH Terms

Conditions

Motor Activity; Alcohol Drinking; Smoking

Condition Hierarchy (Ancestors)

Behavior; Drinking Behavior

Study Officials

• Anette Hjartåker, PhD

  University of Oslo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paula Berstad, PhD

CONTACT

+4793293235; pber@fhi.no

Ane S. Kværner, PhD

CONTACT

+4790115747; a.s.kvarner@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a five-armed, parallel group and randomized controlled trial. Three of the arms are intervention arms, while two arms are control arms.

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 21, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): December 31, 2041
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)