Walking Away: Structured Education Versus Written Information for Individuals With High Risk of Developing Type 2 Diabetes
NCT ID: NCT00941954
Last Updated: 2015-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
833 participants
INTERVENTIONAL
2009-09-30
2014-01-31
Brief Summary
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This cluster randomised controlled trial will investigate whether a person-centred group educational programme can increase walking activity and reduce the risk of developing diabetes in high-risk individuals identified in primary care settings. In total 804 patients will be recruited to the study. Physical activity levels, glucose control, incidence of type 2 diabetes and anthropometric measurements (e.g. weight) will be tested on an annual basis over three years.
This trial will be the first to test the feasibility, efficacy and value for money of a physical activity intervention aimed at reducing the risk of diabetes in a community setting in a multi-ethnic population in the UK.
Primary research hypothesis: A pragmatic structured education programme aimed at promoting walking activity initiates long-term increases in physical activity in individuals identified through a risk score as having an increased risk of developing type 2 diabetes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Lifestyle counseling
A group-based structured educational programme.
Structured Education
The intervention group will be offered a group-based structured educational programme aimed at promoting increased ambulatory activity by targeting perceptions and knowledge of diabetes risk, physical activity self-efficacy, barriers to physical activity and self-regulatory skills based on pedometer use. The programme will employ a person-centred approach to patient education that is based on self-management programmes for individuals with type 2 diabetes and prediabetes that have been developed and tested by our research group. The programme will be designed to be delivered to 5-10 participants by two trained educators and is 3.5 hours long. Brief follow-up counselling will be offered once every 6 months.
Control
Written Information (booklet).
Written Information
Control subjects will receive a booklet detailing information on risk factors for type 2 diabetes (T2DM) and cardiovascular disease (CVD) and how physical activity can be used to prevent T2DM and CVD.
Interventions
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Structured Education
The intervention group will be offered a group-based structured educational programme aimed at promoting increased ambulatory activity by targeting perceptions and knowledge of diabetes risk, physical activity self-efficacy, barriers to physical activity and self-regulatory skills based on pedometer use. The programme will employ a person-centred approach to patient education that is based on self-management programmes for individuals with type 2 diabetes and prediabetes that have been developed and tested by our research group. The programme will be designed to be delivered to 5-10 participants by two trained educators and is 3.5 hours long. Brief follow-up counselling will be offered once every 6 months.
Written Information
Control subjects will receive a booklet detailing information on risk factors for type 2 diabetes (T2DM) and cardiovascular disease (CVD) and how physical activity can be used to prevent T2DM and CVD.
Eligibility Criteria
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Inclusion Criteria
* High risk of developing type 2 diabetes as identified through a risk score
Exclusion Criteria
* Taking steroid medication
* Serious chronic illness preventing participation in trial
* Unable to speak English
18 Years
ALL
No
Sponsors
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University of Leicester
OTHER
National Institute for Health Research, United Kingdom
OTHER_GOV
University Hospitals, Leicester
OTHER
Responsible Party
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Principal Investigators
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Melanie J Davies, MD
Role: PRINCIPAL_INVESTIGATOR
University of Leicester; University Hospitals of Leicester NHS Trust
Locations
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University Hospitals of Leicester (UHL)
Leicester, , United Kingdom
Countries
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References
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Yates T, Gray LJ, Henson J, Edwardson CL, Khunti K, Davies MJ. Impact of Depression and Anxiety on Change to Physical Activity Following a Pragmatic Diabetes Prevention Program Within Primary Care: Pooled Analysis From Two Randomized Controlled Trials. Diabetes Care. 2019 Oct;42(10):1847-1853. doi: 10.2337/dc19-0400. Epub 2019 Aug 9.
Henson J, Edwardson CL, Morgan B, Horsfield MA, Khunti K, Davies MJ, Yates T. Sedentary Time and MRI-Derived Measures of Adiposity in Active Versus Inactive Individuals. Obesity (Silver Spring). 2018 Jan;26(1):29-36. doi: 10.1002/oby.22034.
Bodicoat DH, O'Donovan G, Dalton AM, Gray LJ, Yates T, Edwardson C, Hill S, Webb DR, Khunti K, Davies MJ, Jones AP. The association between neighbourhood greenspace and type 2 diabetes in a large cross-sectional study. BMJ Open. 2014 Dec 23;4(12):e006076. doi: 10.1136/bmjopen-2014-006076.
Yates T, Davies MJ, Henson J, Troughton J, Edwardson C, Gray LJ, Khunti K. Walking away from type 2 diabetes: trial protocol of a cluster randomised controlled trial evaluating a structured education programme in those at high risk of developing type 2 diabetes. BMC Fam Pract. 2012 May 29;13:46. doi: 10.1186/1471-2296-13-46.
Other Identifiers
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LNR CLRN 10343
Identifier Type: -
Identifier Source: org_study_id
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