Type 2 Diabetes MellitusSTANDNCT01301196
Reducing Sedentary Behaviour in Young Adults at Risk of Diabetes
A study testing Educational workshop in people with Type 2 Diabetes Mellitus, run by Loughborough University at 1 site in United Kingdom.
Trial summary
Excessive periods of time spent sitting may be a risk factor for diabetes. Current lifestyles encourage large amounts of sitting (sedentary behaviour) through increasing car use, computers, and appealing screen-based home entertainment systems. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Educational workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to Mar 2012
- 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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18-30 years old
- family history of T2DM or CVD (first degree relative)
- BMI ≥ 25 (≥ 23 for south Asians)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals of Leicester
Leicester, Leics
Emma Wilmott, MB ChB, Emma.Wilmot@uhl-tr.nhs.uk
Stuart Biddle, PhD
About this study
Official title: An Intervention to Decrease Sedentary Behaviour in Young Adults at Risk of type2 Diabetes Mellitus - Project STAND
Excessive periods of time spent sitting may be a risk factor for diabetes. Current lifestyles encourage large amounts of sitting (sedentary behaviour) through increasing car use, computers, and appealing screen-based home entertainment systems. Methods to help change such behaviours are now needed, particularly for those with a high risk of developing a chronic disease, such as diabetes. The investigators propose to decrease sedentary behaviour in a multi-ethnic group of young adults at risk of diabetes through an educational intervention (attending a workshop and having prompts). If successful, this could have significant public health benefits given the widespread nature of sedentary behaviour.
Read the detailed description
The rising prevalence of obesity and sedentary behaviour has lead to an epidemic of Type 2 Diabetes (T2DM). As the health and economic costs of T2DM continue to increase, there is an urgent need for an effective lifestyle intervention to prevent the development of T2DM. Our group have previously developed successful structured education programmes: DESMOND improved lifestyle, depression, illness beliefs, weight and CV risk in adults with T2DM; PREPARE increased activity levels and reduced 2 hour glucose values in people with pre-diabetes. Project STAND will assess the effect of theory driven structured education, facilitated using automated technology, on sedentary behaviour and health outcomes in young adults at risk of T2DM. Participants will be randomised to a control (C) or intervention (I) group, the latter given structured education, based on the PREPARE and DESMOND programmes, with the aim of reducing sedentary behaviour. The structured education programme will incorporate movement technology to facilitate participant feedback and self-monitoring.This will be the first UK trial to address sedentary behaviour change in a population of younger adults at risk of T2DM. Our results will provide a platform for the development of a range of future multidisciplinary interventions in this rapidly expanding high-risk population.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Educational workshop
- Keywords
- sedentary behaviour, diabetes, structured education, 18-30 years olds, family history of T2DM or CVD, BMI ≥ 25 (≥23 for south Asians)
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational workshopBehavioural
3h attendance at educational workshop plus self-monitoring
| Study group | Role | What they receive |
|---|---|---|
| Behaviour change | Experimental | Attendance at 3-h workshop Receives: Behavioral: Educational workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedentary behaviour
Sedentary behaviour (time < 100 counts/min as assessed by 1-week accelerometry, using the new Actigraph GT3X) at 12 months
Measured: 12 months
Secondary outcomes (5)
Biomarkers
Fasting and 2h glucose, blood lipid profile, insulin, HbA1c, hsCRP, TNFα, IL-6, and IL-6
Measured: 12 months
Screen time
self-reported screen-time (TV, computers, games)
Measured: 12 months
Self-reported behaviour
Time in motorised transport, physical activity (accelerometer and IPAQ questionnaire)
Measured: 12 months
Biological measures
Body weight, waist circumference, blood pressure
Measured: 12 months
Psychosocial indicators
Illness perceptions (brief IPQ), efficacy beliefs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startOct 2010
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301196
- Sponsor's protocol ID
- MRC 91409
- Acronym
- STAND
- Status last verified
- Oct 2010
- First submitted
- 22 Feb 2011
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention to Decrease Sedentary Behaviour in Young Adults at Risk of type2 Diabetes Mellitus - Project STAND
- ClinicalTrials.gov ID
- NCT01301196
- Acronym / sponsor ID
- STAND / MRC 91409
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- sedentary behaviour, diabetes, structured education, 18-30 years olds, family history of T2DM or CVD, BMI ≥ 25 (≥23 for south Asians)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- Oct 2010
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 23 Feb 2011 (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.
Excessive periods of time spent sitting may be a risk factor for diabetes. Current lifestyles encourage large amounts of sitting (sedentary behaviour) through increasing car use, computers, and appealing screen-based home entertainment systems. Methods to help change such behaviours are now needed, particularly for those with a high risk of developing a chronic disease, such as diabetes. The investigators propose to decrease sedentary behaviour in a multi-ethnic group of young adults at risk of diabetes through an educational intervention (attending a workshop and having prompts). If successful, this could have significant public health benefits given the widespread nature of sedentary behaviour.
Detailed description
The rising prevalence of obesity and sedentary behaviour has lead to an epidemic of Type 2 Diabetes (T2DM). As the health and economic costs of T2DM continue to increase, there is an urgent need for an effective lifestyle intervention to prevent the development of T2DM. Our group have previously developed successful structured education programmes: DESMOND improved lifestyle, depression, illness beliefs, weight and CV risk in adults with T2DM; PREPARE increased activity levels and reduced 2 hour glucose values in people with pre-diabetes. Project STAND will assess the effect of theory driven structured education, facilitated using automated technology, on sedentary behaviour and health outcomes in young adults at risk of T2DM. Participants will be randomised to a control (C) or intervention (I) group, the latter given structured education, based on the PREPARE and DESMOND programmes, with the aim of reducing sedentary behaviour. The structured education programme will incorporate movement technology to facilitate participant feedback and self-monitoring.This will be the first UK trial to address sedentary behaviour change in a population of younger adults at risk of T2DM. Our results will provide a platform for the development of a range of future multidisciplinary interventions in this rapidly expanding high-risk population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behaviour change | Experimental | Behavioral: Educational workshopAttendance at 3-h workshop |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged 18-30 years old
- family history of T2DM or CVD (first degree relative)
- BMI ≥ 25 (≥ 23 for south Asians)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Educational workshop3h attendance at educational workshop plus self-monitoring | Behavioural | Behaviour change |
Primary outcome
Sedentary behaviour
Time frame: 12 months
Sedentary behaviour (time < 100 counts/min as assessed by 1-week accelerometry, using the new Actigraph GT3X) at 12 months
5 secondary outcomes
Biomarkers
Time frame: 12 months
Screen time
Time frame: 12 months
Self-reported behaviour
Time frame: 12 months
Biological measures
Time frame: 12 months
Psychosocial indicators
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational workshop in people with Type 2 Diabetes Mellitus, run by Loughborough University 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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 23 Feb 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedentary behaviour (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2011.