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Walking Away: Structured Education Versus Written Information for Individuals With High Risk of Developing Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00941954
Recruitment Status : Completed
First Posted : July 20, 2009
Last Update Posted : September 9, 2015
Sponsor:
Collaborators:
University of Leicester
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University Hospitals, Leicester

Study Description
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Brief Summary:

Diabetes is a debilitating chronic disease reaching epidemic proportions. Lack of physical activity is a key factor driving this epidemic and it is therefore vital that workable methods of encouraging people to exercise and reducing inactivity are developed and tested if we are to stem the rising tide of diabetes.

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.


Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Structured Education Behavioral: Written Information Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 833 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Walking Away From Type 2 Diabetes: a Cluster Randomized Controlled Trial to Investigate the Effect of Structured Education on Walking Activity in Those With a High Risk of Developing Type 2 Diabetes
Study Start Date : September 2009
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Lifestyle counseling
A group−based structured educational programme.
 Behavioral: 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.
Active Comparator: Control
Written Information (booklet).
 Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in ambulatory activity (walking) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Light−, moderate− and vigorous−intensity physical activity [ Time Frame: 12 months; 24 months; 36 months ]
  2. Time spent in sedentary activities [ Time Frame: 12 months; 24 months; 36 months ]
  3. Fasting and 2−hour post−challenge plasma glucose [ Time Frame: 12 months; 24 months; 36 months ]
  4. Glycosylated hemoglobin (HbA1c) [ Time Frame: 12 months; 24 months; 36 months ]
  5. Advanced glycation end products [ Time Frame: 12 months; 24 months; 36 months ]
  6. Fasting and 2−hour post−challange plasma insulin [ Time Frame: 12 months; 24 months; 36 months ]
  7. Adipokines (leptin, interleukin 6 and tumor necrosis factor alpha) [ Time Frame: 12 months; 24 months; 36 months ]
  8. C−reactive protein [ Time Frame: 12 months; 24 months; 36 months ]
  9. Standard anthropometric variables [ Time Frame: 12 months; 24 months; 36 months ]
  10. Visceral adiposity (sub−set of participants) [ Time Frame: 12 months; 24 months; 36 months ]
  11. Muscle mass (sub−set of participants) [ Time Frame: 12 months; 24 months; 36 months ]
  12. Illness perceptions and efficacy beliefs [ Time Frame: 12 months; 24 months; 36 months ]
  13. Health related quality of life [ Time Frame: 12 months; 24 months; 36 months ]
  14. Depression [ Time Frame: 12 months; 24 months; 36 months ]
  15. Change in ambulatory activity (walking) [ Time Frame: 24 months; 36 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18+
  • High risk of developing type 2 diabetes as identified through a risk score

Exclusion Criteria:

  • Diagnosed diabetes
  • Taking steroid medication
  • Serious chronic illness preventing participation in trial
  • Unable to speak English
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941954


Locations
United Kingdom
University Hospitals of Leicester (UHL)
Leicester, United Kingdom, LE5 4PW
Sponsors and Collaborators
University Hospitals, Leicester
University of Leicester
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Melanie J Davies, MD University of Leicester; University Hospitals of Leicester NHS Trust
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT00941954     History of Changes
Other Study ID Numbers: LNR CLRN 10343
First Posted: July 20, 2009    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015

Keywords provided by University Hospitals, Leicester:
Physical activity
Diabetes
Prevention
Pedometer
Walking
 Structured education
Randomized
Risk score
Impaired glucose regulation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases