Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Other
Study 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 participants 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
Primary outcome measure
1. Self reported physical activity
2. Intentions for self-reported physical activity
Secondary outcome measures
No secondary outcome measures
Overall study start date
01/05/2006
Overall study end date
30/01/2007
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
England, United Kingdom
Study 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
England
United Kingdom
Sponsor type
University/education
Website
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|