DiabetesNCT00941954
Walking Away: Structured Education Versus Written Information for Individuals With High Risk of Developing Type 2 Diabetes
A study testing Structured Education and Written Information in people with Diabetes, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
Diabetes is a debilitating chronic disease reaching epidemic proportions. Lack of physical activity is a key factor driving this epidemic and it is therefore vital that workable methods of encouraging people to exercise and reducing inactivity are developed and tested if we are to stem the rising tide of diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Structured Education and Written Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 833 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+
- High risk of developing type 2 diabetes as identified through a risk score
Who cannot join
- Diagnosed diabetes
- Taking steroid medication
- Serious chronic illness preventing participation in trial
- Unable to speak English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Leicester (UHL)
Leicester, LE5 4PW
About this study
Official title: Walking Away From Type 2 Diabetes: a Cluster Randomized Controlled Trial to Investigate the Effect of Structured Education on Walking Activity in Those With a High Risk of Developing Type 2 Diabetes
Diabetes is a debilitating chronic disease reaching epidemic proportions. Lack of physical activity is a key factor driving this epidemic and it is therefore vital that workable methods of encouraging people to exercise and reducing inactivity are developed and tested if we are to stem the rising tide of diabetes.
This cluster randomised controlled trial will investigate whether a person-centred group educational programme can increase walking activity and reduce the risk of developing diabetes in high-risk individuals identified in primary care settings. In total 804 patients will be recruited to the study. Physical activity levels, glucose control, incidence of type 2 diabetes and anthropometric measurements (e.g. weight) will be tested on an annual basis over three years.
Read more
This trial will be the first to test the feasibility, efficacy and value for money of a physical activity intervention aimed at reducing the risk of diabetes in a community setting in a multi-ethnic population in the UK.
Primary research 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.
- Conditions
- Diabetes
- Being tested
- Structured Education, Written Information
- Keywords
- Physical activity, Diabetes, Prevention, Pedometer, Walking, Structured education, Randomized, Risk score, Impaired glucose regulation
- Medical subject headings
- Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured EducationBehavioural
The intervention group will be offered a group-based structured educational programme aimed at promoting increased ambulatory activity by targeting perceptions and knowledge of diabetes risk, physical activity self-efficacy, barriers to physical activity and self-regulatory skills based on pedometer use. The programme will employ a person-centred approach to patient education that is based on self-management programmes for individuals with type 2 diabetes and prediabetes that have been developed and tested by our research group. The programme will be designed to be delivered to 5-10 participants by two trained educators and is 3.5 hours long. Brief follow-up counselling will be offered once every 6 months.
Written InformationBehavioural
Control subjects will receive a booklet detailing information on risk factors for type 2 diabetes (T2DM) and cardiovascular disease (CVD) and how physical activity can be used to prevent T2DM and CVD.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | A group-based structured educational programme. Receives: Behavioral: Structured Education |
| Control | Active comparator | Written Information (booklet). Receives: Behavioral: Written Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ambulatory activity (walking)
Measured: 12 months
Secondary outcomes (15)
Light-, moderate- and vigorous-intensity physical activity
Measured: 12 months; 24 months; 36 months
Time spent in sedentary activities
Measured: 12 months; 24 months; 36 months
Fasting and 2-hour post-challenge plasma glucose
Measured: 12 months; 24 months; 36 months
Glycosylated hemoglobin (HbA1c)
Measured: 12 months; 24 months; 36 months
Advanced glycation end products
Measured: 12 months; 24 months; 36 months
Fasting and 2-hour post-challange plasma insulin
Measured: 12 months; 24 months; 36 months
Adipokines (leptin, interleukin 6 and tumor necrosis factor alpha)
Measured: 12 months; 24 months; 36 months
C-reactive protein
Measured: 12 months; 24 months; 36 months
Standard anthropometric variables
Measured: 12 months; 24 months; 36 months
Visceral adiposity (sub-set of participants)
Measured: 12 months; 24 months; 36 months
Muscle mass (sub-set of participants)
Measured: 12 months; 24 months; 36 months
Illness perceptions and efficacy beliefs
Measured: 12 months; 24 months; 36 months
Health related quality of life
Measured: 12 months; 24 months; 36 months
Depression
Measured: 12 months; 24 months; 36 months
Change in ambulatory activity (walking)
Measured: 24 months; 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 833 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leicester, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Melanie J Davies, MD, Principal investigator, University of Leicester; University Hospitals of Leicester NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941954
- Sponsor's protocol ID
- LNR CLRN 10343
- Status last verified
- Sep 2015
- First submitted
- 16 Jul 2009
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yates T, Gray LJ, Henson J, Edwardson CL, Khunti K, Davies MJ. Impact of Depression and Anxiety on Change to Physical Activity Following a Pragmatic Diabetes Prevention Program Within Primary Care: Pooled Analysis From Two Randomized Controlled Trials. Diabetes Care. 2019 Oct;42(10):1847-1853. doi: 10.2337/dc19-0400. Epub 2019 Aug 9.
PubMed 31399440Henson J, Edwardson CL, Morgan B, Horsfield MA, Khunti K, Davies MJ, Yates T. Sedentary Time and MRI-Derived Measures of Adiposity in Active Versus Inactive Individuals. Obesity (Silver Spring). 2018 Jan;26(1):29-36. doi: 10.1002/oby.22034.
PubMed 29265769Bodicoat DH, O'Donovan G, Dalton AM, Gray LJ, Yates T, Edwardson C, Hill S, Webb DR, Khunti K, Davies MJ, Jones AP. The association between neighbourhood greenspace and type 2 diabetes in a large cross-sectional study. BMJ Open. 2014 Dec 23;4(12):e006076. doi: 10.1136/bmjopen-2014-006076.
PubMed 25537783Yates T, Davies MJ, Henson J, Troughton J, Edwardson C, Gray LJ, Khunti K. Walking away from type 2 diabetes: trial protocol of a cluster randomised controlled trial evaluating a structured education programme in those at high risk of developing type 2 diabetes. BMC Fam Pract. 2012 May 29;13:46. doi: 10.1186/1471-2296-13-46.
PubMed 22642610
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking Away From Type 2 Diabetes: a Cluster Randomized Controlled Trial to Investigate the Effect of Structured Education on Walking Activity in Those With a High Risk of Developing Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00941954
- Acronym / sponsor ID
- LNR CLRN 10343
- Conditions
- Diabetes
- Keywords
- Physical activity, Diabetes, Prevention, Pedometer, Walking, Structured education, Randomized, Risk score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 833 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- University of Leicester, National Institute for Health Research, United Kingdom
- Study start
- Sep 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes is a debilitating chronic disease reaching epidemic proportions. Lack of physical activity is a key factor driving this epidemic and it is therefore vital that workable methods of encouraging people to exercise and reducing inactivity are developed and tested if we are to stem the rising tide of diabetes.
This cluster randomised controlled trial will investigate whether a person-centred group educational programme can increase walking activity and reduce the risk of developing diabetes in high-risk individuals identified in primary care settings. In total 804 patients will be recruited to the study. Physical activity levels, glucose control, incidence of type 2 diabetes and anthropometric measurements (e.g. weight) will be tested on an annual basis over three years.
This trial will be the first to test the feasibility, efficacy and value for money of a physical activity intervention aimed at reducing the risk of diabetes in a community setting in a multi-ethnic population in the UK.
Primary research 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Structured EducationA group-based structured educational programme. |
| Control | Active comparator | Behavioral: Written InformationWritten Information (booklet). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18+
- High risk of developing type 2 diabetes as identified through a risk score
Key exclusion criteria (4 listed)
- Diagnosed diabetes
- Taking steroid medication
- Serious chronic illness preventing participation in trial
- Unable to speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured EducationThe intervention group will be offered a group-based structured educational programme aimed at promoting increased ambulatory activity by targeting perceptions and knowledge of diabetes risk, physical activity self-efficacy, barriers to physical activity and self-regulatory skills based on pedometer use. The programme will employ a person-centred approach to patient education that is based on self-management programmes for individuals with type 2 diabetes and prediabetes that have been developed and tested by our research group. The programme will be designed to be delivered to 5-10 participants by two trained educators and is 3.5 hours long. Brief follow-up counselling will be offered once every 6 months. | Behavioural | Lifestyle counseling |
| Written InformationControl subjects will receive a booklet detailing information on risk factors for type 2 diabetes (T2DM) and cardiovascular disease (CVD) and how physical activity can be used to prevent T2DM and CVD. | Behavioural | Control |
Primary outcome
Change in ambulatory activity (walking)
Time frame: 12 months
15 secondary outcomes
Light-, moderate- and vigorous-intensity physical activity
Time frame: 12 months; 24 months; 36 months
Time spent in sedentary activities
Time frame: 12 months; 24 months; 36 months
Fasting and 2-hour post-challenge plasma glucose
Time frame: 12 months; 24 months; 36 months
Glycosylated hemoglobin (HbA1c)
Time frame: 12 months; 24 months; 36 months
Advanced glycation end products
Time frame: 12 months; 24 months; 36 months
Fasting and 2-hour post-challange plasma insulin
Time frame: 12 months; 24 months; 36 months
Adipokines (leptin, interleukin 6 and tumor necrosis factor alpha)
Time frame: 12 months; 24 months; 36 months
C-reactive protein
Time frame: 12 months; 24 months; 36 months
Standard anthropometric variables
Time frame: 12 months; 24 months; 36 months
Visceral adiposity (sub-set of participants)
Time frame: 12 months; 24 months; 36 months
Muscle mass (sub-set of participants)
Time frame: 12 months; 24 months; 36 months
Illness perceptions and efficacy beliefs
Time frame: 12 months; 24 months; 36 months
Health related quality of life
Time frame: 12 months; 24 months; 36 months
Depression
Time frame: 12 months; 24 months; 36 months
Change in ambulatory activity (walking)
Time frame: 24 months; 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
- Derived from this study: PubMed 31399440Yates T, Gray LJ, Henson J, Edwardson CL, Khunti K, Davies MJ. Impact of Depression and Anxiety on Change to Physical Activity Following a Pragmatic Diabetes Prevention Program Within Primary Care: Pooled Analysis From Two Randomized Controlled Trials. Diabetes Care. 2019 Oct;42(10):1847-1853. doi: 10.2337/dc19-0400. Epub 2019 Aug 9.
- Derived from this study: PubMed 29265769Henson J, Edwardson CL, Morgan B, Horsfield MA, Khunti K, Davies MJ, Yates T. Sedentary Time and MRI-Derived Measures of Adiposity in Active Versus Inactive Individuals. Obesity (Silver Spring). 2018 Jan;26(1):29-36. doi: 10.1002/oby.22034.
- Derived from this study: PubMed 25537783Bodicoat DH, O'Donovan G, Dalton AM, Gray LJ, Yates T, Edwardson C, Hill S, Webb DR, Khunti K, Davies MJ, Jones AP. The association between neighbourhood greenspace and type 2 diabetes in a large cross-sectional study. BMJ Open. 2014 Dec 23;4(12):e006076. doi: 10.1136/bmjopen-2014-006076.
- Derived from this study: PubMed 22642610Yates T, Davies MJ, Henson J, Troughton J, Edwardson C, Gray LJ, Khunti K. Walking away from type 2 diabetes: trial protocol of a cluster randomised controlled trial evaluating a structured education programme in those at high risk of developing type 2 diabetes. BMC Fam Pract. 2012 May 29;13:46. doi: 10.1186/1471-2296-13-46.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie J Davies, MD principal investigator
University of Leicester; University Hospitals of Leicester NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Education and Written Information in people with Diabetes, run by University Hospitals, Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ambulatory activity (walking) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00941954, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015.