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| Name | Class |
|---|---|
| University of Leicester | OTHER |
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle counseling | Experimental | A group-based structured educational programme. |
|
| Control | Active Comparator | Written Information (booklet). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured Education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ambulatory activity (walking) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Light-, moderate- and vigorous-intensity physical activity | 12 months; 24 months; 36 months | |
| Time spent in sedentary activities | 12 months; 24 months; 36 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melanie J Davies, MD | University of Leicester; University Hospitals of Leicester NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Leicester (UHL) | Leicester | LE5 4PW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31399440 | Derived | Yates T, Gray LJ, Henson J, Edwardson CL, Khunti K, Davies MJ. Impact of Depression and Anxiety on Change to Physical Activity Following a Pragmatic Diabetes Prevention Program Within Primary Care: Pooled Analysis From Two Randomized Controlled Trials. Diabetes Care. 2019 Oct;42(10):1847-1853. doi: 10.2337/dc19-0400. Epub 2019 Aug 9. | |
| 29265769 |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Written Information | Behavioral | 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. |
|
| 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 |
| Standard anthropometric variables | 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 |
| Henson J, Edwardson CL, Morgan B, Horsfield MA, Khunti K, Davies MJ, Yates T. Sedentary Time and MRI-Derived Measures of Adiposity in Active Versus Inactive Individuals. Obesity (Silver Spring). 2018 Jan;26(1):29-36. doi: 10.1002/oby.22034. |
| 25537783 | Derived | 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. |
| 22642610 | Derived | 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. |
| D001519 | Behavior |