Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/02/2011
Date assigned
22/02/2011
Last edited
24/06/2016
Prospective/Retrospective
Retrospectively 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 Emma Wilmot

ORCID ID

Contact details

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
-
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 below 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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

Publication citations

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes

24/06/2016: Publication reference added.