NCT04745325

Brief Summary

Smartphone apps targeting alcohol consumption are increasingly employed as a means to help people reduce their alcohol consumption. Recognizing this potential, there has been an explosion of app development for unhealthy alcohol use, as well as other health-related behaviours. This study will recruit people who consume alcohol in an unhealthy manner. Participants will be assigned by chance to one of two groups and will be contacted 6 months after consenting to the study to assess changes in their drinking. In addition, this study will help us understand which components of the smartphone app are important to use in order to promote reductions in alcohol consumption. An app with proven efficacy, made widely available and free-of-charge to Canadians, will provide a much needed option to help those in need to reduce their alcohol use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
761

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

May 27, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

February 4, 2021

Last Update Submit

July 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total number of drinks consumed in a typical week

    self-reported change

    6-months follow-up

Secondary Outcomes (2)

  • Frequency of heavy drinking days

    6-months follow-up

  • Number of consequences associated with drinking

    6-months follow-up

Study Arms (2)

Smartphone app - full access

EXPERIMENTAL

A smartphone app containing 5 modules: 1) personalized feedback on alcohol use (containing normative feedback by age and sex for those located in the Canada), 2) self-monitoring and goal setting tool, 3) tool to choose a designated driver, 4) blood alcohol content (BAC) calculator, and 5) educational information on alcohol use and its consequences (i.e. "fact sheets").

Behavioral: SMAART Canada smartphone app

Smartphone App - education only

ACTIVE COMPARATOR

A version of the Smartphone app containing only the module with the educational information on alcohol use and its consequences (i.e. "fact sheets").

Behavioral: SMAART Canada smartphone app

Interventions

a smartphone app designed to promote reductions in alcohol consumption among people who drink in a hazardous fashion

Smartphone App - education onlySmartphone app - full access

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • score of 8 or more on the Alcohol Use Disorders Identification Test
  • currently us a smartphone running iOS or Android

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Canada

Location

Related Publications (1)

  • Cunningham JA, Godinho A, Schell C, Studer J, Wardell JD, Garnett C, Bertholet N. Randomized controlled trial of a smartphone app designed to reduce unhealthy alcohol consumption. Internet Interv. 2024 May 17;36:100747. doi: 10.1016/j.invent.2024.100747. eCollection 2024 Jun.

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 9, 2021

Study Start

May 27, 2021

Primary Completion

October 26, 2022

Study Completion

April 30, 2023

Last Updated

July 7, 2023

Record last verified: 2023-07

Locations