NCT02681900

Brief Summary

This study tests the effects of a self-affirmation manipulation on (i) acceptance of a health message detailing the risks of alcohol consumption, (ii) engagement with the health message and (iii) alcohol consumption at 7-day follow-up. Half of the participants complete a self-affirmation manipulation, where they reflect on their most important values, whereas the other half complete a control equivalent, where they reflect on their least important values. Immediately post-intervention, all participants then receive information about the risks of alcohol consumption and complete measures of message acceptance and engagement with the materials. Seven days after intervention, participants self-report their alcohol consumption in the previous 7 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
Last Updated

February 15, 2016

Status Verified

February 1, 2016

Enrollment Period

2 months

First QC Date

February 2, 2016

Last Update Submit

February 9, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Alcohol consumption 7 days after intervention

    Seven days after the intervention, participants are contacted and asked to report their alcohol consumption over the previous 7-day period via self-report items. Participants report the type of alcohol (e.g., beer, spirit), type of container (e.g., small glass, pint, single measure) and the number of each type of drink they had consumed on each day over the previous 7 days using the adapted version (Armitage, Harris, \& Arden, 2011) of the timeline fallback technique (Sobell \& Sobell, 1992). The total number of units consumed by each participant was then calculated using the UK NHS alcohol unit calculator (NHS Choices, 2013: www.nhs.uk/tools/pages/alcohol-unit-calculator.aspx).

    7 days after intervention

Secondary Outcomes (2)

  • Effect of intervention on acceptance of health information

    Immediately after intervention

  • Effect of intervention on engagement with health information

    Immediately after intervention

Study Arms (2)

Self-affirmation

EXPERIMENTAL

Participants in the self-affirmation arm write about their most important value, reasons why is important and an example of when they enacted that value. This is the Self-affirmation manipulation task as described in the intervention.

Behavioral: Self-affirmation manipulation task

Control

ACTIVE COMPARATOR

Participants in this arm complete a control equivalent of the self-affirmation task, where they write about their least important value, reasons why is may be important to someone else and an example of when another person may have enacted that value. This is the Control task as described in the intervention.

Behavioral: Control task

Interventions

Participants in the self-affirmation condition indicate their most important value, give three examples of why this value is important to them and one example of something they had done to demonstrate its importance.

Self-affirmation
Control taskBEHAVIORAL

People in the control condition indicate their least important value, three examples of why that value could be important to someone else, and describe something that person could do to show its importance.

Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Drinkers

You may not qualify if:

  • Male
  • Non-drinkers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sussex

Falmer, Brighton, BN1 9RH, United Kingdom

Location

Related Publications (1)

  • Fox KJ, Harris PR, Jessop DC. Experimentally Manipulated Self-Affirmation Promotes Reduced Alcohol Consumption in Response to Narrative Information. Ann Behav Med. 2017 Dec;51(6):931-935. doi: 10.1007/s12160-017-9912-2.

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Kerry J Fox, MSc

    University of Sussex

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2016

First Posted

February 15, 2016

Study Start

October 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 15, 2016

Record last verified: 2016-02

Locations