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Walking away from diabetes: structured education versus written information for individuals with high risk of developing type 2 diabetes

Walking away from type 2 diabetes: a cluster-randomised controlled trial to investigate the effect of structured education on walking activity in those with a high risk of developing type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31392913
Enrollment
804
Registered
2009-09-23
Start date
2009-09-01
Completion date
Unknown
Last updated
2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Nutritional, Metabolic, Endocrine Unspecified diabetes mellitus

Interventions

Experimental arm (lifestyle counselling): The lifestyle counselling (a group-based structured educational programme to promote physical activity) in the experimental arm is 3.5 - 4 hours at baseline.
the main objectives of the programme will also be reinforced. Each follow-up programme will last two hours and will be conducted after the participant's annual clinical measurement session. All partic

Sponsors

University Hospitals of Leicester NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and older, either sex 2. High risk of developing type 2 diabetes as identified through a risk score

Exclusion criteria

Exclusion criteria: 1. Diagnosed diabetes 2. Taking steroid medication 3. Serious chronic illness preventing participation in trial 4. Unable to speak English

Design outcomes

Primary

MeasureTime frame
Change in ambulatory activity (walking); measured at 0, 12, 24 and 36 months using: 1. A uniaxial accelerometer 2. International Physical Activity Questionnaire (IPAQ)

Secondary

MeasureTime frame
Measured at 0, 12, 24 and 36 months: 1. Light-, moderate- and vigorous-intensity physical activity, measured using a uniaxial accelerometer 2. Time spent in sedentary activities assessed by International Physical Activity Questionnaire (IPAQ) 3. Fasting and 2-hour post-challenge plasma glucose, measured by venous sampling 4. Glycosylated haemoglobin (HbA1c), measured by venous sampling 5. Advanced glycation end products, measured by a dermal spectroscopic measurement technique (SAGE, VeraLight, USA) 6. Fasting and 2-hour post-challange plasma insulin, measured by venous sampling 7. Adipokines (leptin, interleukin 6 and tumour necrosis factor alpha), measured by venous sampling 8. C-reactive protein, measured by venous sampling 9. Standard anthropometric variables (including weight, body mass index [BMI], body fat %, waist circumference) 10. Visceral adiposity (sub-set of participants), measured by single section abdominal magnetic resonance imaging (MRI) scan 11. Muscle mass (sub-set of participants), measured by whole body dual energy X-ray absorptiometry (DEXA) scan 12. Illness perceptions and efficacy beliefs, measured using the Brief Illness Perceptions Questionnaire and 100% Confidence Rating scale (exercise self-efficacy) 13. Health related quality of life, measured using the EQ-5D 14. Depression, measured using the Hospital Anxiety and Depression Scale (HADS)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026