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

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:

MedlinePlus related topics: Diabetes Type 2

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.

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):

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.


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 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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