LifestyleNCT03396029
Tailored Written Lifestyle Feedback in Colorectal Cancer Screening
A study testing Individually tailored lifestyle feedback and Standard leaflet in people with Lifestyle and Diet Habit, run by Oslo University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Lifestyle, Diet Habit, Smoking Cessation
- What is being tested?
- Individually tailored lifestyle feedback and Standard leaflet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,642 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2014to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Invited to sigmoidoscopy screening in the Norwegian Bowel Cancer Screening Pilot Study
Who cannot join
- 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.
About this study
Official title: A Randomized Trial of 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.
Read the 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.
- Conditions
- Lifestyle, Diet Habit, Smoking Cessation, Physical Activity, Alcohol Drinking, Body Weight
- Being tested
- Individually tailored lifestyle feedback, Standard leaflet
- Keywords
- Lifestyle intervention, Diet, Smoking cessation, Physical activity, Alcohol, Body mass index, colorectal cancer screening, sigmoidoscopy
- Medical subject headings
- Feeding Behavior, Smoking Cessation, Motor Activity, Alcohol Drinking, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individually tailored lifestyle feedbackBehavioural
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 leafletBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Individually tailored lifestyle feedback | Experimental | Written, standardized individually tailored lifestyle feedback based on participants responses to a lifestyle questionnaire, and a leaflet on healthy lifestyle mailed to the participant. Receives: Behavioral: Individually tailored lifestyle feedback; Behavioral: Standard leaflet |
| Standard leaflet | Experimental | A leaflet on healthy lifestyle mailed to the participant. Receives: Behavioral: Standard leaflet |
| Control | No intervention | No contact with the participant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A questionnaire-based lifestyle score
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)
Measured: One year; from pre-screening until one year after
Secondary outcomes (5)
Smoking status
Self-reported smoking status (smoking vs. non-smoking), assessed by a questionnaire
Measured: One year; from pre-screening until one year after
Alcohol consumption
Self-reported consumption of alcoholic beverages (glasses/week), assessed by a questionnaire
Measured: One year; from pre-screening until one year after
Physical activity
Self-reported weekly time spent in physical activity (number of 30-minute activity sessions per week), assessed by a questionnaire
Measured: One year; from pre-screening until one year after
Consumption of fruit and vegetables
Self-reported consumption of fruit, berries and vegetables (servings per day), assessed by a questionnaire
Measured: One year; from pre-screening until one year after
Body weight
Self-reported body weight (whole kilograms), assessed by a questionnaire
Measured: One year; from pre-screening until one year after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start1 Nov 2014
- Primary completion30 Oct 2016
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LifestyleStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3,642 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Berstad, Oslo University Hospital
- Investigators
- Paula Berstad, PhD, Principal investigator, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396029
- Sponsor's protocol ID
- 2011/1272
- Status last verified
- Aug 2019
- First submitted
- 29 Dec 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Tailored Written Lifestyle Feedback in Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT03396029
- Acronym / sponsor ID
- 2011/1272
- Conditions
- Lifestyle, Diet Habit, Smoking Cessation, Physical Activity, Alcohol Drinking, Body Weight
- Keywords
- Lifestyle intervention, Diet, Smoking cessation, Physical activity, Alcohol, Body mass index, colorectal cancer screening, sigmoidoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,642 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individually tailored lifestyle feedback | Experimental | Behavioral: Individually tailored lifestyle feedback, Behavioral: Standard leafletWritten, standardized individually tailored lifestyle feedback based on participants responses to a lifestyle questionnaire, and a leaflet on healthy lifestyle mailed to the participant. |
| Standard leaflet | Experimental | Behavioral: Standard leafletA leaflet on healthy lifestyle mailed to the participant. |
| Control | No intervention | –No contact with the participant. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Invited to sigmoidoscopy screening in the Norwegian Bowel Cancer Screening Pilot Study
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individually tailored lifestyle feedbackThe written, standardized individually tailored lifestyle feedback includes feedback on consumption of fruit, berries and vegetables and alcohol, physical activity, smoking and body mass index. | Behavioural | Individually tailored lifestyle feedback |
| Standard leafletThe 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. | Behavioural | Individually tailored lifestyle feedback, Standard leaflet |
Primary outcome
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)
5 secondary outcomes
Smoking status
Time frame: One year; from pre-screening until one year after
Alcohol consumption
Time frame: One year; from pre-screening until one year after
Physical activity
Time frame: One year; from pre-screening until one year after
Consumption of fruit and vegetables
Time frame: One year; from pre-screening until one year after
Body weight
Time frame: One year; from pre-screening until one year after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Berstad, PhD principal investigator
Norwegian Institute of Public Health
Questions about this trial
What is this clinical trial studying?
A study testing Individually tailored lifestyle feedback and Standard leaflet in people with Lifestyle and Diet Habit, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A questionnaire-based lifestyle score (time frame: One year; from pre-screening until one year after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.