Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LNR CLRN 10343
Study information
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
Acronym
Study 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.
Ethics approval
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
Study design
Interventional cluster-randomised single centre controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/09/2009
Overall trial end date
30/05/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 years and older, either sex
2. High risk of developing type 2 diabetes as identified through a risk score
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
804
Participant exclusion criteria
1. Diagnosed diabetes
2. Taking steroid medication
3. Serious chronic illness preventing participation in trial
4. Unable to speak English
Recruitment start date
01/09/2009
Recruitment end date
30/05/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leicester General Hospital
Leicester
LE1 4PW
United Kingdom
Sponsor information
Organisation
University Hospitals of Leicester NHS Trust (UK)
Sponsor details
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Collaborations for Leadership in Applied Health Research and Care (CLAHRC)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23456209
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26204908
Publication citations
-
Results
Henson J, Yates T, Biddle SJ, Edwardson CL, Khunti K, Wilmot EG, Gray LJ, Gorely T, Nimmo MA, Davies MJ, Associations of objectively measured sedentary behaviour and physical activity with markers of cardiometabolic health., Diabetologia, 2013, 56, 5, 1012-1020, doi: 10.1007/s00125-013-2845-9.
-
Results
Yates T, Henson J, Edwardson C, Bodicoat DH, Davies MJ, Khunti K, Differences in levels of physical activity between White and South Asian populations within a healthcare setting: impact of measurement type in a cross-sectional study, BMJ Open, 2015 , 5, 7, e006181, doi: 10.1136/bmjopen-2014-006181.