Prediabetic StatePREPARENCT00566319
Can Structured Education Promote Physical Activity in Those Identified With an Increased Risk of Developing Diabetes
A study testing PREPARE with pedometer and PREPARE in people with Prediabetic State, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
This study is a three-armed randomised controlled trial that aims to determine the effect of a structured educational programme on physical activity levels and glucose tolerance in individuals with impaired glucose tolerance (IGT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetic State
- What is being tested?
- PREPARE with pedometer and PREPARE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2006to Apr 2008
- 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
- 2-h blood glucose ≥ 7.8 mmol/l and < 11.1 mmol/l
- Fasting plasma glucose < 7 mmol/l
- BMI ≥ 25 kg/m2 (or 23 kg/m2 for those from a South Asian ethnic origin)
- Aged 18 or over
Who cannot join
- Taking medication known to significantly interfere with glucose tolerance
- Participating in regular vigorous physical activity
- Unable to participate in moderate intensity physical activity
- Pregnant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Leicester
Leicester, Leicester, LE1 5WW
About this study
Official title: A Randomised Controlled Trial to Investigate the Effect of a Structured Educational Programme on Physical Activity Levels and Glucose Tolerance in People With Impaired Glucose Tolerance
This study is a three-armed randomised controlled trial that aims to determine the effect of a structured educational programme on physical activity levels and glucose tolerance in individuals with impaired glucose tolerance (IGT). The educational programme is designed to promote physical activity by targeting perceptions and knowledge of IGT, exercise self-efficacy, and self-regulatory skills. The study will also investigate whether the effectiveness of the educational programme at promoting self-regulatory skills and physical activity is enhanced by the inclusion of a pedometer and personalised step/day goals.
- Conditions
- Prediabetic State
- Being tested
- PREPARE with pedometer, PREPARE
- Keywords
- Exercise
- Medical subject headings
- Prediabetic State, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREPARE with pedometerBehavioural
Structured educational programme with pedometer use
PREPAREBehavioural
Structured educational programme
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: PREPARE with pedometer |
| 2 | Active comparator | Not described Receives: Behavioral: PREPARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-hour glucose
Measured: 2 hours
Secondary outcomes (1)
Pedometer counts, Fasting glucose, total cholesterol, HDL-cholesterol, LDL- cholesterol, TNFα, IL-6, CRP, systolic and diastolic blood pressure, body mass, waist circumference, BMI, physical activity, psychological determinants
Measured: Pedometer counts, 7 days ; everything else, 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2007 (estimated)
- Study startOct 2006
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prediabetic StateStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes UK
- Investigators
- Melanie Davies, MD, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566319
- Sponsor's protocol ID
- 06/Q2502/29
- Other IDs
- BDA:RD05/0003159
- Acronym
- PREPARE
- Status last verified
- Nov 2007
- First submitted
- 30 Nov 2007
- Last updated
- 26 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yates T, Davies MJ, Sehmi S, Gorely T, Khunti K. The Pre-diabetes Risk Education and Physical Activity Recommendation and Encouragement (PREPARE) programme study: are improvements in glucose regulation sustained at 2 years? Diabet Med. 2011 Oct;28(10):1268-71. doi: 10.1111/j.1464-5491.2011.03357.x.
PubMed 21672008
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Investigate the Effect of a Structured Educational Programme on Physical Activity Levels and Glucose Tolerance in People With Impaired Glucose Tolerance
- ClinicalTrials.gov ID
- NCT00566319
- Acronym / sponsor ID
- PREPARE / 06/Q2502/29
- Conditions
- Prediabetic State
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- Diabetes UK
- Study start
- Oct 2006
- Study completion
- Apr 2008 (actual)
- First posted
- 3 Dec 2007 (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.
This study is a three-armed randomised controlled trial that aims to determine the effect of a structured educational programme on physical activity levels and glucose tolerance in individuals with impaired glucose tolerance (IGT). The educational programme is designed to promote physical activity by targeting perceptions and knowledge of IGT, exercise self-efficacy, and self-regulatory skills. The study will also investigate whether the effectiveness of the educational programme at promoting self-regulatory skills and physical activity is enhanced by the inclusion of a pedometer and personalised step/day goals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: PREPARE with pedometer |
| 2 | Active comparator | Behavioral: PREPARE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 2-h blood glucose ≥ 7.8 mmol/l and < 11.1 mmol/l
- Fasting plasma glucose < 7 mmol/l
- BMI ≥ 25 kg/m2 (or 23 kg/m2 for those from a South Asian ethnic origin)
- Aged 18 or over
Key exclusion criteria (4 listed)
- Taking medication known to significantly interfere with glucose tolerance
- Participating in regular vigorous physical activity
- Unable to participate in moderate intensity physical activity
- Pregnant
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 |
|---|---|---|
| PREPARE with pedometerStructured educational programme with pedometer use | Behavioural | 1 |
| PREPAREStructured educational programme | Behavioural | 2 |
Primary outcome
2-hour glucose
Time frame: 2 hours
1 secondary outcome
Pedometer counts, Fasting glucose, total cholesterol, HDL-cholesterol, LDL- cholesterol, TNFα, IL-6, CRP, systolic and diastolic blood pressure, body mass, waist circumference, BMI, physical activity, psychological determinants
Time frame: Pedometer counts, 7 days ; everything else, 2 hours
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 26 Nov 2008.
- Derived from this study: PubMed 21672008Yates T, Davies MJ, Sehmi S, Gorely T, Khunti K. The Pre-diabetes Risk Education and Physical Activity Recommendation and Encouragement (PREPARE) programme study: are improvements in glucose regulation sustained at 2 years? Diabet Med. 2011 Oct;28(10):1268-71. doi: 10.1111/j.1464-5491.2011.03357.x.
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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 Davies, MD principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREPARE with pedometer and PREPARE in people with Prediabetic State, 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 4 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 26 Nov 2008. 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?
2-hour glucose (time frame: 2 hours). 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 NCT00566319, which also lists 1 linked publication.
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 26 Nov 2008.