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

ISRCTN ISRCTN31392913
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

Leicester Diabetes Centre (Broadleaf)
Leicester General Hospital
Gwendolen Road
Leicester
LE1 4PW
United Kingdom

Study information

Study designInterventional cluster-randomised single centre controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleWalking 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 objectivesA 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) studiedDiabetes
InterventionExperimental 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 typeOther
Primary outcome measureChange 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 measuresMeasured 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 date01/09/2009
Completion date30/05/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants804
Key inclusion criteria1. Aged 18 years and older, either sex
2. High risk of developing type 2 diabetes as identified through a risk score
Key exclusion criteria1. Diagnosed diabetes
2. Taking steroid medication
3. Serious chronic illness preventing participation in trial
4. Unable to speak English
Date of first enrolment01/09/2009
Date of final enrolment30/05/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Leicester General Hospital
Leicester
LE1 4PW
United Kingdom

Sponsor information

University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre

Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom

Website http://www.uhl-tr.nhs.uk/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
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.