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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University Hospitals, Leicester.
Recruitment status was  Recruiting
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

July 16, 2009
July 10, 2012
September 2009
December 2013   (final data collection date for primary outcome measure)
Change in ambulatory activity (walking) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00941954 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Walking Away: Structured Education Versus Written Information for Individuals With High Risk of Developing Type 2 Diabetes
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Diabetes
  • 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.
  • 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.
  • Experimental: Lifestyle counseling
    A group−based structured educational programme.
    Intervention: Behavioral: Structured Education
  • Active Comparator: Control
    Written Information (booklet).
    Intervention: Behavioral: Written Information
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
804
May 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
United Kingdom
 
NCT00941954
LNR CLRN 10343
Yes
University Hospitals, Leicester
University Hospitals, Leicester
  • University of Leicester
  • National Institute for Health Research, United Kingdom
Principal Investigator: Melanie J Davies, MD University of Leicester; University Hospitals of Leicester NHS Trust
University Hospitals, Leicester
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP