Contact information
Type
Scientific
Primary contact
Dr Emma Wilmot
ORCID ID
Contact details
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
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emma.wilmot@uhl-tr.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8347
Study information
Scientific title
An intervention to decrease sedentary behaviour in young adults at risk of type 2 diabetes: project STAND (sedentary time and diabetes)
Acronym
DRN 465 (STAND)
Study hypothesis
An intervention to decrease sedentary behaviour in young adults at risk of Type 2 Diabetes Mellitus
Ethics approval
10/H0403/13; First MREC approval date 07/05/2010
Study design
Randomised interventional process of care
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measure
Reduced sedentary behaviour measured by an accelerometer at 12 months
Secondary outcome measures
Not provided at the time of registration
Overall trial start date
17/11/2010
Overall trial end date
28/02/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 178; UK Sample Size: 178;
Participant 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
Recruitment start date
17/11/2010
Recruitment end date
28/02/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Sponsor information
Organisation
University Hospitals of Leicester NHS Trust (UK)
Sponsor details
Diabetes Research
Level 1 - Victoria
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
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
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22151909
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23456209
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26623654
2017 process evaluation in: http://www.ncbi.nlm.nih.gov/pubmed/28088243
Publication citations
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Protocol
Wilmot EG, Davies MJ, Edwardson CL, Gorely T, Khunti K, Nimmo M, Yates T, Biddle SJ, Rationale and study design for a randomised controlled trial to reduce sedentary time in adults at risk of type 2 diabetes mellitus: project stand (Sedentary Time ANd diabetes)., BMC Public Health, 2011, 11, 908, doi: 10.1186/1471-2458-11-908.
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Results
Henson J, Yates T, Biddle SJ, Edwardson CL, Khunti K, Wilmot EG, Gray LJ, Gorely T, Nimmo MA, Davies MJ, Associations of objectively measured sedentary behaviour and physical activity with markers of cardiometabolic health., Diabetologia, 2013, 56, 5, 1012-1020, doi: 10.1007/s00125-013-2845-9.
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Results
Biddle SJ, Edwardson CL, Wilmot EG, Yates T, Gorely T, Bodicoat DH, Ashra N, Khunti K, Nimmo MA, Davies MJ, A Randomised Controlled Trial to Reduce Sedentary Time in Young Adults at Risk of Type 2 Diabetes Mellitus: Project STAND (Sedentary Time ANd Diabetes), PLoS One, 2015, 10, 12, e0143398, doi: 10.1371/journal.pone.0143398.