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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Structured Education
* Behavioral: Written Information


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br>A group-based structured educational programme. | Behavioral: Structured Education<br>* 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.<br>|
| Active Comparator: Control<br>Written Information (booklet). | Behavioral: Written Information<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ambulatory activity (walking) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Diabetes, Prevention, Pedometer, Walking, Structured education, Randomized, Risk score, Impaired glucose regulation