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CompletedNCT03396029Updated Aug 28, 2019

Tailored Written Lifestyle Feedback in Colorectal Cancer Screening

An interventional study of Individually tailored lifestyle feedback and Standard leaflet in Lifestyle, Diet Habit and Smoking Cessation, sponsored by Oslo University Hospital. Completed. Open to participants aged 50 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
3,642
Allocation
Randomized
Ages
50 Years to 74 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
50 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Invited to sigmoidoscopy screening in the Norwegian Bowel Cancer Screening Pilot Study

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
3,642 participants (actual)

Study arms

  • Experimental
    Individually tailored lifestyle feedback

    Written, standardized individually tailored lifestyle feedback based on participants responses to a lifestyle questionnaire, and a leaflet on healthy lifestyle mailed to the participant.

    Behavioral: Individually tailored lifestyle feedback · Behavioral: Standard leaflet

  • Experimental
    Standard leaflet

    A leaflet on healthy lifestyle mailed to the participant.

    Behavioral: Standard leaflet

  • No intervention
    Control

    No contact with the participant.

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.

  • BehavioralStandard leaflet

    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.

05

What researchers measure

Primary outcomes

  1. 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)

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

Secondary outcomes

  1. Smoking status

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

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

  2. Alcohol consumption

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

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

  3. Physical activity

    Self-reported weekly time spent in physical activity (number of 30-minute activity sessions per week), assessed by a questionnaire

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

  4. Consumption of fruit and vegetables

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

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

  5. Body weight

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

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03396029
Lead sponsor
Oslo University Hospital
Responsible party
Paula Berstad (Researcher, Oslo University Hospital) — Principal investigator
First posted
Jan 10, 2018
Start date
Nov 1, 2014
Primary completion
Oct 30, 2016
Completion
Oct 31, 2018
Last update
Aug 28, 2019

Study contacts

Paula Berstad, PhD
principal investigator · Norwegian Institute of Public Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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