Diabetes
Conditions
Keywords
Physical activity, Diabetes, Prevention, Pedometer, Walking, Structured education, Randomized, Risk score, Impaired glucose regulation
Brief 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.
Interventions
BEHAVIORALStructured 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.
BEHAVIORALWritten 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.
Sponsors
University of Leicester
National Institute for Health Research, United Kingdom
University Hospitals, Leicester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ambulatory activity (walking) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Time spent in sedentary activities | 12 months; 24 months; 36 months |
| Fasting and 2-hour post-challenge plasma glucose | 12 months; 24 months; 36 months |
| Glycosylated hemoglobin (HbA1c) | 12 months; 24 months; 36 months |
| Advanced glycation end products | 12 months; 24 months; 36 months |
| Fasting and 2-hour post-challange plasma insulin | 12 months; 24 months; 36 months |
| Adipokines (leptin, interleukin 6 and tumor necrosis factor alpha) | 12 months; 24 months; 36 months |
| C-reactive protein | 12 months; 24 months; 36 months |
| Light-, moderate- and vigorous-intensity physical activity | 12 months; 24 months; 36 months |
| Visceral adiposity (sub-set of participants) | 12 months; 24 months; 36 months |
| Muscle mass (sub-set of participants) | 12 months; 24 months; 36 months |
| Illness perceptions and efficacy beliefs | 12 months; 24 months; 36 months |
| Health related quality of life | 12 months; 24 months; 36 months |
| Depression | 12 months; 24 months; 36 months |
| Change in ambulatory activity (walking) | 24 months; 36 months |
| Standard anthropometric variables | 12 months; 24 months; 36 months |
Countries
United Kingdom
Outcome results
None listed