An intervention to decrease sedentary behaviour in young adults at risk of type 2 diabetes: project STAND (sedentary time and diabetes)

ISRCTN	ISRCTN08434554
DOI	https://doi.org/10.1186/ISRCTN08434554
Secondary identifying numbers	8347

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Emma Wilmot
Scientific

Leicester Royal Infirmary , Infirmary Square
Leicester
LE1 5WW
United Kingdom

Email	emma.wilmot@uhl-tr.nhs.uk

Study design	Randomised interventional process of care
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	An intervention to decrease sedentary behaviour in young adults at risk of type 2 diabetes: project STAND (sedentary time and diabetes)
Study acronym	DRN 465 (STAND)
Study objectives	An intervention to decrease sedentary behaviour in young adults at risk of Type 2 Diabetes Mellitus
Ethics approval(s)	10/H0403/13; First MREC approval date 07/05/2010
Health condition(s) or problem(s) studied	Topic: Diabetes Research Network, Primary Care Research Network for England; Subtopic: Type 2, Not Assigned; Disease: All Diseases, Education
Intervention	Structured education, based on the PREPARE and DESMOND programmes, with the aim of reducing sedentary behaviour. The structured education programme will incorporate movement technology to facilitate participant feedback and self-monitoring.
Intervention type	Behavioural
Primary outcome measure	Reduced sedentary behaviour measured by an accelerometer at 12 months
Secondary outcome measures	Not provided at the time of registration
Overall study start date	17/11/2010
Completion date	28/02/2013

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	40 Years
Sex	Both
Target number of participants	Planned Sample Size: 178; UK Sample Size: 178;
Key inclusion criteria	1. Age 18-40 years with a BMI >30 (>27.5 for South Asian participants) or age 18-40 years with a BMI >25 (>23 for South Asian participants) plus one additional risk factor: 2.1. Family history of diabetes or cardiovascular disease (in a first degree relative) 2.2. Previous gestational diabetes 2.3. Polycystic ovarian syndrome 2.4. HbA1c >5.8% or previous impaired glucose regulation
Key exclusion criteria	1. Physical condition which limits full participation in the study 2. Active psychotic illness or an significant illness which, in the view of the investigators, would prevent full participation 3. Steroid use 4. Inability to communicate in verbal and written English 5. Diabetes
Date of first enrolment	17/11/2010
Date of final enrolment	28/02/2013

Leicester Royal Infirmary

Infirmary Square
Leicester
LE1 5WW
United Kingdom

University Hospitals of Leicester NHS Trust (UK)
University/education

Diabetes Research
Level 1 - Victoria, Leicester Royal Infirmary , Infirmary Square
Leicester
LE1 5WW
England
United Kingdom

Website	http://www.uhl-tr.nhs.uk/
"ROR"	https://ror.org/02fha3693

Research council

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

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

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	08/12/2011	Yes	No
Results article	results	01/05/2013	Yes	No
Results article	results	01/12/2015	Yes	No
Other publications	process evaluation	14/01/2017	Yes	No

20/10/2017: Publication reference added.
24/06/2016: Publication reference added.