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

This study is currently recruiting participants.
Verified July 2012 by University Hospitals, Leicester
Sponsor:
Collaborators:
University of Leicester
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT00941954
First received: July 16, 2009
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Diabetes
 Behavioral: Structured Education
Behavioral: Written Information

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:
  • Change in ambulatory activity (walking) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Light−, moderate− and vigorous−intensity physical activity [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
  • Time spent in sedentary activities [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
  • Fasting and 2−hour post−challenge plasma glucose [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
  • Glycosylated hemoglobin (HbA1c) [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
  • Advanced glycation end products [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
  • Fasting and 2−hour post−challange plasma insulin [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
  • Adipokines (leptin, interleukin 6 and tumor necrosis factor alpha) [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
  • C−reactive protein [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
  • Standard anthropometric variables [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
  • Visceral adiposity (sub−set of participants) [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
  • Muscle mass (sub−set of participants) [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
  • Illness perceptions and efficacy beliefs [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
  • Change in ambulatory activity (walking) [ Time Frame: 24 months; 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 804
Study Start Date: September 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941954

Contacts
Contact: Tom Yates, PhD 0300 303 1573 ext 7453 ty20@le.ac.uk
Contact: Emily J Steventon, BSc 0116 252 3199 ejs49@le.ac.uk

Locations
United Kingdom
University Hospitals of Leicester (UHL) Recruiting
Leicester, United Kingdom, LE5 4PW
Contact: Tom Yates, PhD     0116 258 7453     ty20@le.ac.uk    
Sub-Investigator: Tom Yates, PhD            
Sub-Investigator: Kamlesh Khunti, MD            
Sub-Investigator: Jacqui Troughton, BSc            
Sub-Investigator: Laura Gray, PhD            
Sub-Investigator: Bruno Morgan, PhD            
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

No publications provided by University Hospitals, Leicester

Additional 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
Study First Received: July 16, 2009
Last Updated: July 10, 2012
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on May 23, 2013