Condition category
Mental and Behavioural Disorders
Date applied
31/05/2017
Date assigned
02/06/2017
Last edited
02/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Interventions to reduce alcohol use typically include several elements such as information on the risks of alcohol consumption, motivation for sensible drinking, or strategies to resist drinking in certain situations. However, the effectiveness of these single intervention elements within comprehensive programs has not been addressed so far, but could give valuable insights for the development of future interventions. Just-in-time interventions provided via mobile devices (i.e., text messages) are intended to help people to make healthy decisions “in the moment”, and thus have a near-future impact. The aim of this study is to test the impact of such just-in-time delivered interventions on alcohol use and binge drinking.

Who can participate?
Adolescents aged 16 or over who binge drink (i.e., who have drunk 4 (female)/5 (male) or more alcoholic drinks on one or more occasion in the last 30 days)

What does the study involve?
On two of their typically indicated drinking days at 5pm, participants are randomly allocated to receive either:
1. An intervention including two text messages: one text message where they choose one of two predetermined if-then plans to practice sensible drinking, and another text message prompt to visualize the chosen plan
2. No intervention
The number of alcoholic drinks they consume in the evening/night is assessed by another text message at 5pm on the following day.

What are the possible benefits and risks of participating?
Alcohol use may be lower after receiving the sensible drinking text message. No risks of participation are expected.

Where is the study run from?
Swiss Research Institute for Public Health and Addiction (Switzerland)

When is the study starting and how long is it expected to run for?
January 2017 to December 2018

Who is funding the study?
1. Swiss Research Institute for Public Health and Addiction (Switzerland)
2. Swiss Federal Office of Public Health (Switzerland)

Who is the main contact?
Dr Severin Haug
severin.haug@isgf.uzh.ch

Trial website

Contact information

Type

Scientific

Primary contact

Dr Severin Haug

ORCID ID

http://orcid.org/0000-0002-6539-5045

Contact details

Konradstrasse 32
Zurich
8031
Switzerland
+41 (0)44 448 11 74
severin.haug@isgf.uzh.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17.4.11

Study information

Scientific title

Efficacy of a just-in-time delivered planning intervention to reduce alcohol use in adolescents with hazardous alcohol consumption: a micro-randomized controlled trial

Acronym

Study hypothesis

1. Alcohol use on the evening/night will be lower at points in time with digital micro intervention compared to assessment only
2. Binge drinking prevalence on the evening/night will be lower at points in time with digital micro intervention compared to assessment only

Ethics approval

Ethics committee of the Faculty of Philosophy at the University of Zurich, 18/04/2017, ref: 17.4.11

Study design

Micro-randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Home

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Alcohol prevention

Intervention

Participants receive the just-in-time delivered planning intervention to reduce alcohol use on their typically indicated drinking day at 5pm. The study has an AB/BA crossover design, in which each participant receives the intervention and the control in a randomized order. The randomization sequence will be created using computerized random numbers. There is a period of at least 2 weeks between the intervention and control.

Intervention points in time include:
1. Assessment of state of receptivity and state of vulnerability via SMS text message question (“Are you planning to go out or meet with friend this evening?”) on the typical individually indicated drinking day at 5pm
2. Confirmation of receptivity and vulnerability by a text message reply (“Yes”) from the participant
3. The digital micro intervention where participants can choose one of two predetermined if-then plans to practice sensible drinking via SMS text messaging and another text message prompt to visualize the chosen plan

Control points in time only include 1 and 2.

Follow-up assessments will be conducted 24 hours after the assessment of state of receptivity and vulnerability in both intervention and control points in time.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Number of alcoholic standard drinks consumed during the previous evening/night, measured via an SMS text message "How many alcoholic drinks did you have last evening/night?” at 24 hours after the assessment of state of receptivity and vulnerability (i.e., at 5pm the following day)

Secondary outcome measures

Binge drinking: consumption of 5 (male) or 4 (female) or more alcoholic standard drinks during the previous evening/night, measured via an SMS text message "How many alcoholic drinks did you have last evening/night?” at 24 hours after the assessment of state of receptivity and vulnerability (i.e., at 5pm the following day)

Overall trial start date

01/01/2017

Overall trial end date

31/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Ownership of a mobile phone
2. Hazardous alcohol use defined by binge drinking: consumption of 5 (male; female: 4) or more alcoholic standard drinks on one or more occasions within 30 days preceding the baseline assessment
3. Aged 16 or over

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

79

Participant exclusion criteria

1. No alcohol consumption with friends or when going out in the evening
2. Typical drinking time with friends or when going out: in the morning or afternoon
3. Age < 16

Recruitment start date

22/06/2017

Recruitment end date

31/10/2018

Locations

Countries of recruitment

Switzerland

Trial participating centre

Swiss Research Institute for Public Health and Addiction
Zurich
8031
Switzerland

Sponsor information

Organisation

Swiss Reseach Institute for Public Health and Addiction

Sponsor details

Konradstrasse 32
Zurich
8031
Switzerland

Sponsor type

University/education

Website

www.isgf.ch

Funders

Funder type

University/education

Funder name

Swiss Research Institute for Public Health and Addiction

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swiss Federal Office of Public Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a psychological or medical peer reviewed journal around one year after the overall trial end date.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Severin Haug (severin.haug@isgf.uzh.ch).

Intention to publish date

31/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes