Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/07/2009
Date assigned
23/09/2009
Last edited
29/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Melanie Davies

ORCID ID

Contact details

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

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

http://www.uhl-tr.nhs.uk/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes

29/03/2016: Publication reference added.