Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/04/2006
Date assigned
25/04/2006
Last edited
27/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alison Wright

ORCID ID

Contact details

King's College London
Health Psychology
5th Floor
Thomas Guy House
Guy's Campus
London
SE1 9RT
United Kingdom
+44 (0)20 7188 2597
alison.wright@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A pragmatic randomised trial of the impact of brief, written anticipated regret manipulations on intentions for, and subsequent self-reported, physical activity in adults receiving normal results of diabetes screening

Acronym

Study hypothesis

Brief written anticipated regret manipulations can promote intentions for, and self-reported, physical activity in people receiving normal results of screening for type two diabetes.

As of 17/06/2009 this record was updated to include a new anticipated end date; the initial end date at the time of registration was 31/12/2006.

Ethics approval

Leicestershire, Northamptonshire and Rutland Research Ethics Committee, November 2005, ref: 7254

Study design

Pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

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

Condition

Prevention of type two diabetes or promotion of physical activity in healthy individuals

Intervention

The interventions consist of written information which is sent in conjunction with the letter confirming the results of a participant’s diabetes test. Participants are randomly allocated to one of five groups:
1. Anticipated regret group, no consequences made salient
2. Anticipated regret group, short term consequences made salient
3. Anticipated regret group, long term consequences made salient
4. Control group one: test result and physical activity message but no written anticipated regret manipulation; anticipated regret assessed on questionnaire
5. Control group two: test result and physical activity message but no anticipated regret manipulation; anticipated regret not assessed on questionnaire

As of 17/06/2009 the end of recruitment date for this trial was 08/12/2006.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Self reported physical activity
2. Intentions for self-reported physical activity

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/05/2006

Overall trial end date

30/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Individuals will be eligible to participate in the current study if they receive a normal result of an oral glucose tolerance test for diabetes performed as part of the Leicester part of the ADDITION study (ISRCTN99175498).

Added 17/06/2009:
1. White European participants aged between 40 and 75 years, either sex
2. Asian, Black or Chinese participants aged between 25 and 75 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

450, distributed across five groups

Participant exclusion criteria

Potential participants will be excluded from the ADDITION study and thus ineligible for this study if they:
1. Are housebound
2. Have a terminal illness
3. Have diabetes mellitus
4. Have an active psychotic illness resulting in the individual being unable to provide informed consent
5. Are pregnant or lactating
6. Are simultaneously participating in any other clinical trials

Recruitment start date

01/05/2006

Recruitment end date

30/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 071202)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

27/04/2016: No publications found, verifying study status with principal investigator