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NCT Number: NCT00941954

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

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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Key information

Conditions

Diabetes Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of Leicester (UHL)

Leicester, LE5 4PW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in ambulatory activity (walking)

    Time frame: 12 months

Secondary outcomes

  1. Light-, moderate- and vigorous-intensity physical activity

    Time frame: 12 months; 24 months; 36 months

  2. Time spent in sedentary activities

    Time frame: 12 months; 24 months; 36 months

  3. Fasting and 2-hour post-challenge plasma glucose

    Time frame: 12 months; 24 months; 36 months

  4. Glycosylated hemoglobin (HbA1c)

    Time frame: 12 months; 24 months; 36 months

  5. Advanced glycation end products

    Time frame: 12 months; 24 months; 36 months

  6. Fasting and 2-hour post-challange plasma insulin

    Time frame: 12 months; 24 months; 36 months

  7. Adipokines (leptin, interleukin 6 and tumor necrosis factor alpha)

    Time frame: 12 months; 24 months; 36 months

  8. C-reactive protein

    Time frame: 12 months; 24 months; 36 months

  9. Standard anthropometric variables

    Time frame: 12 months; 24 months; 36 months

  10. Visceral adiposity (sub-set of participants)

    Time frame: 12 months; 24 months; 36 months

  11. Muscle mass (sub-set of participants)

    Time frame: 12 months; 24 months; 36 months

  12. Illness perceptions and efficacy beliefs

    Time frame: 12 months; 24 months; 36 months

  13. Health related quality of life

    Time frame: 12 months; 24 months; 36 months

  14. Depression

    Time frame: 12 months; 24 months; 36 months

  15. Change in ambulatory activity (walking)

    Time frame: 24 months; 36 months

Sponsors and collaborators

Lead sponsor

University Hospitals, Leicester

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jul 20, 2009
Registry last updated
Sep 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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