A study of the effects of different types information about physical activity after diabetes screening

ISRCTN	ISRCTN93473629
DOI	https://doi.org/10.1186/ISRCTN93473629
Secondary identifying numbers	N/A

Submission date: 21/04/2006
Registration date: 25/04/2006
Last edited: 25/11/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Alison Wright
Scientific

King's College London
Health Psychology
5th Floor
Thomas Guy House
Guy's Campus
London
SE1 9RT
United Kingdom

Phone	+44 (0)20 7188 2597
Email	alison.wright@kcl.ac.uk

Study information

Study design	Pragmatic randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	30/01/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	450, distributed across five groups
Key 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
Key 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
Date of first enrolment	01/05/2006
Date of final enrolment	30/01/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

King's College London

London
SE1 9RT
United Kingdom

Sponsor information

King's College London (UK)
University/education

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

Website	http://www.kcl.ac.uk/
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Charity

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

25/11/2019: No publications found. Verifying results with principal investigator.
27/04/2016: No publications found, verifying study status with principal investigator