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

Primary Purpose

Alcohol Consumption

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Check Your Drinking (CYD)
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Consumption

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King's College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Check Your Drinking (CYD)

Control

Arm Description

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

No Intervention Control

Outcomes

Primary Outcome Measures

Number of drinks consumed during a typical week
Number of drinks consumed during a typical week

Secondary Outcome Measures

Full Information

First Posted
February 17, 2022
Last Updated
October 7, 2022
Sponsor
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT05258864
Brief Title
Pilot Trial of an Online Personalised Normative Feedback Intervention to Reduce Drinking
Official Title
Pilot Randomised Controlled Trial of an Online Personalised Normative Feedback Intervention to Reduce Drinking Among People With Unhealthy Alcohol Consumption
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 27, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Check Your Drinking (CYD)
Arm Type
Experimental
Arm Description
The CYD is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking
Arm Title
Control
Arm Type
No Intervention
Arm Description
No Intervention Control
Intervention Type
Behavioral
Intervention Name(s)
Check Your Drinking (CYD)
Intervention Description
The CYD is a brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking
Primary Outcome Measure Information:
Title
Number of drinks consumed during a typical week
Description
Number of drinks consumed during a typical week
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
WC2R 2LS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Available upon reasonable request from the senior author after publication of the results from the study.

Learn more about this trial

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

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