NCT03466541

Brief Summary

The aim of this study is to investigate the effectiveness of two workplace interventions (the Riskbruk model and Balance) in reducing risky alcohol consumption, sickness absence and presenteeism. The purpose is to assess whether the Riskbruk model should be implemented in the Norwegian workforce in its entirety, whether the less extensive and costly alternative Balance is sufficient, or if neither one of them show effectiveness compared to usual care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 28, 2022

Status Verified

November 1, 2022

Enrollment Period

12.4 years

First QC Date

March 8, 2018

Last Update Submit

November 22, 2022

Conditions

Keywords

Alcohol consumptionSick leaveWorkplace interventionsPresenteeism

Outcome Measures

Primary Outcomes (2)

  • Change in alcohol consumption

    Baseline and 6 months

  • Change in sickness absence

    Baseline and 6 months

Secondary Outcomes (1)

  • Change in presenteeism

    Baseline and 6 months

Study Arms (3)

Riskbruk

EXPERIMENTAL

The employees randomised to the Riskbruk group will be offered two consultations a ∼15 min with the OHS. The subjects will receive individual feedback on the screening results. During these sessions, Motivational Interviewing will be used.

Behavioral: Riskbruk

Balance

EXPERIMENTAL

The group allocated to the Balance intervention will follow a comprehensive multi-session eHealth intervention with personalised feedback on the screening results.

Behavioral: Balance

Control group/usual care

NO INTERVENTION

The control group will receive the usual follow-up provided by the OHS for persons with risky alcohol behaviour. In order to provide something that appears as a plausible follow-up to the control participants, they will be given a booklet that covers general information about alcohol and potential risks and harms of drinking. The booklet contains no advise on how to achieve a change in drinking behaviour.

Interventions

RiskbrukBEHAVIORAL

The Riskbruk model incorporates alcohol screening through a widely employed alcohol screening questionnaire, the Alcohol Use Disorders Identification Test (AUDIT) and a standard alcohol biomarker, carbohydrate-deficient transferring in serum (CDT), with brief consultations using the motivational interviewing (MI) technique. MI is a collaborative conversation style used to increase awareness and reflection around one's own drinking habits, as well as strengthening the person's motivation for a lifestyle change. The conversation style includes expressing empathy through reflective listening, communicating respect and acceptance of the participants and their feelings, and open up for self-reflection and exploration around the drinking behaviour.

Riskbruk
BalanceBEHAVIORAL

Balance is a new Norwegian eHealth programme, and incorporates two approaches to behaviour modification interventions: a brief interventions and an intensive self-help programme. The intervention is based on cognitive-behavioural and self-help principles, and is given to the participants through multiple interactive sessions.

Balance

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Employees screening positive for at-risk drinking (8+ on the AUDIT)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Stavanger

Stavanger, Rogaland, 4021, Norway

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2018

First Posted

March 15, 2018

Study Start

August 1, 2013

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

November 28, 2022

Record last verified: 2022-11

Locations