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
Protocol serial number	LNR CLRN 10343
Sponsor	University Hospitals of Leicester NHS Trust (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Collaborations for Leadership in Applied Health Research and Care (CLAHRC)

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

Primary study design	Interventional
Study design	Interventional cluster-randomised single centre controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant 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(s)	Change in ambulatory activity (walking); measured at 0, 12, 24 and 36 months using: 1. A uniaxial accelerometer 2. International Physical Activity Questionnaire (IPAQ)
Key secondary outcome measure(s)	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)
Completion date	30/05/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Leicester General Hospital

Leicester
LE1 4PW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/02/2018: Publication reference added.
29/03/2016: Publication reference added.