Walking away from diabetes: structured education versus written information for individuals with high risk of developing type 2 diabetes
ISRCTN | ISRCTN31392913 |
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DOI | https://doi.org/10.1186/ISRCTN31392913 |
Secondary identifying numbers | LNR CLRN 10343 |
- Submission date
- 16/07/2009
- Registration date
- 23/09/2009
- Last edited
- 21/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Melanie Davies
Scientific
Scientific
Leicester Diabetes Centre (Broadleaf)
Leicester General Hospital
Gwendolen Road
Leicester
LE1 4PW
United Kingdom
Study information
Study design | Interventional cluster-randomised single centre controlled trial |
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Primary study design | Interventional |
Secondary study design | Cluster randomised trial |
Study setting(s) | Other |
Study type | Prevention |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | 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 |
Study objectives | 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. |
Ethics approval(s) | Nottingham Research Ethics Committee 2, 02/03/2009, ref: 09/H0408/32. A substantial amendment (1.0) was approved on the 21/05/2009 and a second amendment (2.0) is pending as of 17/07/2009 |
Health condition(s) or problem(s) studied | Diabetes |
Intervention | 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. All individuals will be invited to attend annual group-based sessions (of the education programme) during the trial period. These follow-up programmes will be designed to help participants interpret and analyse their annual biochemical and anthropometric follow-up data, review progress and goals and respond to issues, queries and barriers; 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 participants will also receive telephone contact at 6 months after the initial educational programme and at 6 months after each annual follow-up session where motivational interviewing techniques will be employed to review progress. Control arm: Written information (booklet) on risk factors for type 2 diabetes and cardiovascular disease (CVD) and how physical activity can be used to prevent these conditions. Follow-up measurement sessions will be conducted at 12, 24 and 36 months (for both intervention arms). |
Intervention type | Other |
Primary outcome measure | 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 outcome measures | 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) |
Overall study start date | 01/09/2009 |
Completion date | 30/05/2014 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 804 |
Key inclusion criteria | 1. Aged 18 years and older, either sex 2. High risk of developing type 2 diabetes as identified through a risk score |
Key exclusion criteria | 1. Diagnosed diabetes 2. Taking steroid medication 3. Serious chronic illness preventing participation in trial 4. Unable to speak English |
Date of first enrolment | 01/09/2009 |
Date of final enrolment | 30/05/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leicester General Hospital
Leicester
LE1 4PW
United Kingdom
LE1 4PW
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
Website | http://www.uhl-tr.nhs.uk/ |
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https://ror.org/02fha3693 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Collaborations for Leadership in Applied Health Research and Care (CLAHRC)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/05/2013 | Yes | No | |
Results article | results | 23/07/2015 | Yes | No | |
Results article | results | 13/01/2017 | Yes | No |
Editorial Notes
21/02/2018: Publication reference added.
29/03/2016: Publication reference added.