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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941954
• Other study ID #: LNR CLRN 10343
• Status: Completed
• Phase: N/A
• First received: July 16, 2009
• Last updated: September 7, 2015
• Start date: September 2009
• Est. completion date: January 2014

Study information

• Verified date: September 2015
• Source: University Hospitals, Leicester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 833
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Leicester (UHL)	Leicester

Sponsors (3)

Lead Sponsor	Collaborator
University Hospitals, Leicester	National Institute for Health Research, United Kingdom, University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

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