NCT03396029

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,642

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

December 29, 2017

Last Update Submit

August 27, 2019

Conditions

LifestyleDiet HabitSmoking CessationPhysical ActivityAlcohol DrinkingBody Weight

Keywords

Lifestyle interventionDietSmoking cessationPhysical activityAlcoholBody mass indexcolorectal cancer screeningsigmoidoscopy

Outcome Measures

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)

    One year; from pre-screening until one year after

Secondary Outcomes (5)

  • Smoking status

    One year; from pre-screening until one year after

  • Alcohol consumption

    One year; from pre-screening until one year after

  • Physical activity

    One year; from pre-screening until one year after

  • Consumption of fruit and vegetables

    One year; from pre-screening until one year after

  • Body weight

    One year; from pre-screening until one year after

Study Arms (3)

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.

Behavioral: Individually tailored lifestyle feedbackBehavioral: Standard leaflet

Standard leaflet

EXPERIMENTAL

A leaflet on healthy lifestyle mailed to the participant.

Behavioral: Standard leaflet

Control

NO INTERVENTION

No contact with the participant.

Interventions

Individually tailored lifestyle feedbackBEHAVIORAL

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.

Individually tailored lifestyle feedback
Standard leafletBEHAVIORAL

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.

Individually tailored lifestyle feedbackStandard leaflet

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Feeding BehaviorSmoking CessationMotor ActivityAlcohol DrinkingBody Weight

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorHealth BehaviorDrinking BehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paula Berstad, PhD

    Norwegian Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
A computer programme designed by the research team IT developer carried out the randomization. The recruitment and the contact between the investigators and the participants was mailed. There was no face-to-face contact.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

December 29, 2017

First Posted

January 10, 2018

Study Start

November 1, 2014

Primary Completion

October 30, 2016

Study Completion

October 31, 2018

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share