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Diabetes MellitusMELSNCT04256720

The Multi-Ethnic Lifestyle Study

An observational study of Diabetes Mellitus and Chronic Kidney Diseases, run by University of Leicester at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study design is cross-sectional using a self-completion questionnaire in an English speaking multi-ethic population within Leicester and Leicestershire. The study will adopt a convenient and purposive sampling recruitment strategy across a variety of settings within Leicestershire to facilitate recruitment of a… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
9,500 participants
Where
1 siteUnited Kingdom
Study dates
10 Dec 2018to 1 May 2024
How long will I take part?
5 Years
Phase
Observational
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Participants aged 18 or over who are willing and able to participate in the study.

Who may be able to join

  • Aged 18 years or over.
  • Ability to read and understand English.
  • Has not already completed the questionnaire.
  • Able and willing to complete questionnaire.

Who cannot join

  • Participant unable or unwilling to complete questionnaire.
  • Under the age of 18.
  • Participant has already completed the questionnaire.
  • Unable to read and write in English.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site, 1 recruiting
  • Leicester General Hospital

    Leicester, LE5 4PW

    Jane S Brela, 0116 2584408, jane.brela@uhl-tr.nhs.uk

    Penelope Donley, 0116 2584725, penelope.donley@uhl-tr.nhs.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: The Clustering of Lifestyle Behaviours in a Multi-ethnic Population: A Questionnaire Study

The study design is cross-sectional using a self-completion questionnaire in an English speaking multi-ethic population within Leicester and Leicestershire. The study will adopt a convenient and purposive sampling recruitment strategy across a variety of settings within Leicestershire to facilitate recruitment of a wide range of participants.

Read the detailed description

It is well reported that lifestyle behaviours can play a significant role in health, contributing towards chronic disease and mortality. The World Health Organisation (WHO) describes behavioural risk factors as 'the epidemic of the 21st Century', defining a strategic objective to not only promote health and development, but to prevent and reduce health conditions associated with behavioural risk factors such as smoking, alcohol consumption, unhealthy diets and poor physical activity (1).

In England, reports by the Department of Health (DoH) have identified significant concerns in national attitudes towards health stating that 60% of the adult population hold a negative or fatalistic attitude towards their own health, and that these attitudes are particularly prominent in disadvantaged groups (2). This has been corroborated in recent statistics published this year by Public Health England (PHE) comparing the health status in local authorities with that of the wider population, reporting that in the total for England, 15.5% of the population are active smokers, 35.1% are not physically active (a figure likely to be much higher with the use of objective measures), and 64.8% demonstrate excessive body weight.

When comparing Leicester (reported as one of the 20% most deprived districts in the UK) with this national average, smoking and weight statistics are seen as on par with the wider population benchmark, with significantly lower levels of physical activity (50%), significantly higher rates of reported diabetes (8.9%), and significantly lower life expectancy in both men and women (77.1 and 81.6 years) (3). Leicester is an ethnically diverse city, with a high population of South Asians, who have been shown to be substantially less physically active compared to the national average (4-6), which may contribute to the statistics seen in the city's public health profile. When looking at the same health report for Leicestershire county, reported as one of the 20% least deprived counties in England, the statistics demonstrate that the health of people is proportionally better than that of the wider population average, with only recorded diabetes shown as below the England average, and all other factors reported as either the same or significantly better in comparison, highlighting the potential impact of socioeconomic disparity in health outcomes (7).

An important lifestyle behaviour that is can often be discounted when considering health statistics is sleep and chronotype. Insufficient sleep has been shown to have significant impacts on physical health with multiple large meta-analyses demonstrating associations with obesity and cardiometabolic disease (8-11). These findings have been corroborated by large UK surveys demonstrating that inadequate sleep is associated with increased BMI and poor metabolic profiles (12), as well as increased cardiovascular disease and type 2 diabetes (13). A longitudinal study in the UK also demonstrated links between insufficient sleep with psychological health problems including depression, anxiety and increased experiences of pain (14). An individual's chronotype, understood as a behavioural trait determined by their circadian rhythm to be either morning- or evening orientated, has shown a number of associated health implications. Research has shown that being a "night owl", as opposed to an "early bird", increases the likelihood of a number of physical and psychological health concerns including mood and anxiety disorders, personality disorders, substance misuse, insomnia, sleep apnoea, arterial hypertension, bronchial asthma, type 2 diabetes, and infertility, with an overall lower mortality (15).

While there has been extensive data on the impact of single lifestyle behaviours on disease related outcomes and mortality, the evidence on combined effects of lifestyle behaviours has not received the same attention, although the available data is compelling. In a systematic review and meta-analysis exploring lifestyle factors related to all-cause mortality comprising of 531,804 participants spanning 13.24 years, it was shown that the relative risk was proportionally reduced by 66% with at least four or more healthy lifestyle behaviours (16). In a large UK study exploring the impact of combined health behaviours on mortality, it was shown that smoking status, dietary intake, alcohol consumption and physical activity, when combined, increased risk of mortality four-fold, with demonstrable trends seen as strongest in cardiovascular causes (17).

The tendency for behaviours to cumulatively increase or decrease risk has important implications for health promotion and prevention strategies with further exploration needed to understand and define these. It is also important to examine these factors within a multiethnic population, so as to be able to ensure that any data collected is reflective of the diversity in society and that any conclusions made have validity to appropriate inform health reform, as per the DoH's Research Governance Framework for Health and Social Care (18). The current study aims to explore the clustering of lifestyle behaviours in a multi-ethnic population within Leicester City and Leicestershire County, in both primary and secondary care settings, to understand how lifestyle behaviours present, cumulate, impact upon, and associate with other behaviours and socio-demographic factors in both a healthy population and those with long-term conditions (LTCs).

Being tested
No intervention
Medical subject headings
Diabetes Mellitus, Renal Insufficiency, Chronic, Cardiovascular Diseases, Sleep Apnea, Obstructive, Respiration Disorders, Neoplasms, Stroke, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionBehavioural

    No intervention - questionnaire study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clustering of common lifestyle behaviours

    To investigate the clustering of common lifestyle behaviours in a multi-ethnic population.

    Measured: 5 years

Secondary outcomes (1)
  1. Examine associations socio-demographic factors and lifestyle behaviours

    To examine associations between socio-demographic factors and lifestyle behaviours, in both a healthy population and those with LTCs, to define subgroups with elevated risk of poor health outcomes.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start10 Dec 2018
  3. Primary completion1 Nov 2023 (estimated)
  4. Study completion1 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
9,500 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04256720
Sponsor's protocol ID
0672
Acronym
MELS
Status last verified
Jan 2020
First submitted
3 Oct 2018
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus and Chronic Kidney Diseases, run by University of 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: status not confirmed, as of the sponsor's last update on 5 Feb 2020. 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?

Contact Sarah Clarke (0116 258 8633, Sarah.L.Clarke@uhl-tr.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clustering of common lifestyle behaviours (time frame: 5 years). 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 5 Feb 2020.

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