Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Tracy Sandberg


Contact details

Insitute of Psychological Sciences
Faculty of Health and Medicine
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Understanding and using self-generated validity to promote behaviour change: a randomised trial on increasing uptake of the seasonal flu jab for the over 65s


Study hypothesis

To further our understanding of a phenomena called Self-Generated Validity (SGV) or the Mere Measurement Effect, and use it to promote attendance for the flu jab amongst the over 65s. The SGV refers to the fact that when people are asked to report their intentions to perform a behaviour, they are subsequently more likely to perform the actual behaviour than if they didn'’t report their intentions. This study investigates the optimum conditions needed to produce the strongest effect. These can then be incorporated into future campaigns.

Ethics approval

Bradford REC, 27/07/2011, ref: 11/YH/0229

Study design

Randomised; Interventional; Design type: Prevention

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

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


Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases


The interventions relate to patients being assigned to one of eight conditions and receiving one set of the following:
Group 1: –standard invite materials only (control 1)
Group 2: short questionnaire to tap demographics (age, ethnicity, social class) (control 2)
Group 3:– intention and attitude items (experimental 1) plus demographics
Group 4: –as Group 3 but with post-it (intervention to increase return rate) (experimental 2) plus demographics. Post-it refers to the sticky notes which will be attached to some of the questionnaires to see if there is a difference in return rates between those questionnaires which have them and those which do not.
Group 5: regret, intention and attitude items (experimental 3) plus demographics
Group 6: –regret, intention and attitude items with post-it (experimental 4) plus demographics
Group 7: beneficence, intention and attitude items (experimental 5) plus demographics
Group 8: –beneficence, intention and attitude items with post-it (experimental 6) plus demographics

It is predicted that there will a 'dose response' effectiveness of SGV as detailed below:-
1. Conditions 3-8 will be more effective than conditions 1-2
2. Condition 5 will more effective than condition 3 (adding anticipated regret)
3. Condition 6 will more effective than condition 5 (use of post-it will promote return rate and therefore the engagement with the questionnaire necessary for the optimum effect)
4. Condition 4 will be more effective than condition 3 (as above)
5. Condition 8 will be more effective than condition 7 (as above)
6. Condition 7 will be more effective than condition 3 (adding beneficence)
7. SGV effect will not vary depending on socio-economic status

The research hopes to identify the best way to maximise uptake of the flu jab using SGV.

Intervention type



Phase I

Drug names

Primary outcome measure

Uptake of flu jab for over 65s; timepoint(s): between September 2010 and March 2011

Secondary outcome measures

Duration from invite to uptake in days. Differences in attendance rates by condition, social class and their interaction will also be analysed, as well as the impacts on time delay to uptake. Given that SGV effects may only operate in those completing questionnaires, secondary analysis will examine differences in condition among those who returned completed questionnaires. Analysis will also examine the impact of questionnaire responses on attendance rates within conditions (e.g., is attendance higher among those with stronger intentions to attend).

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

All patients over 65 registered with participating general practitioners (GPs) who are being sent their annual flu jab invite

Target Gender: Male & Female; Lower Age Limit 65 no age limit or unit specified

Participant type


Age group




Target number of participants

Planned Sample Size: 15000; UK Sample Size: 15000; Description: Patients who are over 65 from participating GPs

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
United Kingdom

Sponsor information


University of Leeds (UK)

Sponsor details

Insitute of Psychological Sciences
Faculty of Health and Medicine
United Kingdom

Sponsor type




Funder type

Research council

Funder name

Economic and Social Research Council (ESRC) (UK) Grant Codes: RES 062 23 2220

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

21/03/2017: No publications found, verifying study status with principal investigator.