Clinical Trials Directory

Trials / Completed

CompletedNCT00941954

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
833 (actual)
Sponsor
University Hospitals, Leicester · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALStructured EducationThe 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.
BEHAVIORALWritten InformationControl 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.

Timeline

Start date
2009-09-01
Primary completion
2014-01-01
Completion
2014-01-01
First posted
2009-07-20
Last updated
2015-09-09

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT00941954. Inclusion in this directory is not an endorsement.