Pilot Trial of an Online Personalised Normative Feedback Intervention to Reduce Drinking

Sponsor
King's College London (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05258864
Collaborator
(none)
1,300
1
2
7.1
183.2

Study Details

Study Description

Brief Summary

Unhealthy alcohol consumption is common in the UK and causes tremendous harm to the individual, as well as harm to others. A significant gap in providing alcohol support is that most people with unhealthy alcohol consumption will never receive advice to cut down on their drinking. However, many are interested in self-directed interventions to help them evaluate their drinking and to motivate reductions in alcohol use. One such promising intervention uses online personalised normative feedback (PNF) which compares a person's drinking with others in the general population of the same age and sex. PNF interventions are thought to work because many people with unhealthy alcohol consumption overestimate how much others drink. Multiple trials have demonstrated that providing PNF to people with unhealthy consumption reduces their alcohol use . While several UK websites do provide feedback on assessment of risk (e.g., Down Your Drink introductory section, Alcohol Change UK), there appears to be no online intervention that provides PNF for unhealthy alcohol consumption.

The major objective of this pilot project is to conduct a two-arm, parallel group randomised controlled trial (RCT) in which 1,318 participants recruited from the Prolific website who have identified themselves as drinking 14 or more units per week are randomly assigned to one of two groups - a) those who are offered a PNF report, and b) those in a no intervention comparator group. Participants in the comparator group will not be provided any intervention materials but will instead be given a list of the different components of the PNF feedback and will be asked to think about how useful they would find each of them. Follow-up assessment will occur at 1 and 6 months post-randomisation. The project is described as a pilot because it is a preliminary evaluation of the PNF intervention in a UK context.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Check Your Drinking (CYD)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Pilot Randomised Controlled Trial of an Online Personalised Normative Feedback Intervention to Reduce Drinking Among People With Unhealthy Alcohol Consumption
Actual Study Start Date :
Feb 27, 2022
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Check Your Drinking (CYD)

The CYD is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking

Behavioral: Check Your Drinking (CYD)
The CYD is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking

No Intervention: Control

No Intervention Control

Outcome Measures

Primary Outcome Measures

  1. Number of drinks consumed during a typical week [6 months]

    Number of drinks consumed during a typical week

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Typically consume 14+ standard UK alcohol units per week Willingness to complete a 6-month follow-up survey 18 years of age or older

Contacts and Locations

Locations

Site City State Country Postal Code
1 King's College London London United Kingdom WC2R 2LS

Sponsors and Collaborators

  • King's College London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
King's College London
ClinicalTrials.gov Identifier:
NCT05258864
Other Study ID Numbers:
  • HR-21/22-28339
First Posted:
Feb 28, 2022
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022