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

• Light−, moderate− and vigorous−intensity physical activity [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
• Time spent in sedentary activities [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
• Fasting and 2−hour post−challenge plasma glucose [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
• Glycosylated hemoglobin (HbA1c) [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
• Advanced glycation end products [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
• Fasting and 2−hour post−challange plasma insulin [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
• Adipokines (leptin, interleukin 6 and tumor necrosis factor alpha) [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
• C−reactive protein [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
• Standard anthropometric variables [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
• Visceral adiposity (sub−set of participants) [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
• Muscle mass (sub−set of participants) [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
• Illness perceptions and efficacy beliefs [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
• Health related quality of life [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
• Depression [ Time Frame: 12 months; 24 months; 36 months ] [ Designated as safety issue: No ]
• Change in ambulatory activity (walking) [ Time Frame: 24 months; 36 months ] [ Designated as safety issue: No ]

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.

• Behavioral: Structured 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.
• Behavioral: Written 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.

• Experimental: Lifestyle counseling
  A group−based structured educational programme.
  Intervention: Behavioral: Structured Education
• Active Comparator: Control
  Written Information (booklet).
  Intervention: Behavioral: Written Information

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

• University of Leicester
• National Institute for Health Research, United Kingdom