An interventional study of Structured Education and Written Information in Diabetes, sponsored by University Hospitals, Leicester. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-09.
Sponsored by University Hospitals, Leicester · Not applicable, Interventional, and Prevention
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 833 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University Hospitals, Leicester is the lead sponsor of 67 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A group-based structured educational programme.
Behavioral: Structured Education
Written Information (booklet).
Behavioral: Written Information
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.
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.
Change in ambulatory activity (walking)
Time frame: 12 months
Light-, moderate- and vigorous-intensity physical activity
Time frame: 12 months; 24 months; 36 months
Time spent in sedentary activities
Time frame: 12 months; 24 months; 36 months
Fasting and 2-hour post-challenge plasma glucose
Time frame: 12 months; 24 months; 36 months
Glycosylated hemoglobin (HbA1c)
Time frame: 12 months; 24 months; 36 months
Advanced glycation end products
Time frame: 12 months; 24 months; 36 months
Fasting and 2-hour post-challange plasma insulin
Time frame: 12 months; 24 months; 36 months
Adipokines (leptin, interleukin 6 and tumor necrosis factor alpha)
Time frame: 12 months; 24 months; 36 months
C-reactive protein
Time frame: 12 months; 24 months; 36 months
Standard anthropometric variables
Time frame: 12 months; 24 months; 36 months
Visceral adiposity (sub-set of participants)
Time frame: 12 months; 24 months; 36 months
Muscle mass (sub-set of participants)
Time frame: 12 months; 24 months; 36 months
Illness perceptions and efficacy beliefs
Time frame: 12 months; 24 months; 36 months
Health related quality of life
Time frame: 12 months; 24 months; 36 months
Depression
Time frame: 12 months; 24 months; 36 months
Change in ambulatory activity (walking)
Time frame: 24 months; 36 months
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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University Hospitals, Leicester