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The Multi-Ethnic Lifestyle Study (MELS)

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ClinicalTrials.gov Identifier: NCT04256720
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
University of Leicester

Brief 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 wide range of participants.

Condition or disease Intervention/treatment
Diabetes Mellitus Chronic Kidney Diseases Cardiovascular Diseases Obstructive Sleep Apnea Respiratory Disease Cancer Stroke Chronic Pain Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) Healthy Behavioral: No intervention

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 9500 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 5 Years
Official Title: The Clustering of Lifestyle Behaviours in a Multi-ethnic Population: A Questionnaire Study
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : May 1, 2024

Intervention Details:
  • Behavioral: No intervention
    No intervention - questionnaire study


Primary Outcome Measures :
  1. Clustering of common lifestyle behaviours [ Time Frame: 5 years ]
    To investigate the clustering of common lifestyle behaviours in a multi-ethnic population.


Secondary Outcome Measures :
  1. Examine associations socio-demographic factors and lifestyle behaviours [ Time Frame: 5 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants aged 18 or over who are willing and able to participate in the study.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04256720


Contacts
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Contact: Sarah Clarke 0116 258 8633 Sarah.L.Clarke@uhl-tr.nhs.uk
Contact: Lois Daniels 0116 258 8070 Lois.J.Daniels@uhl-tr.nhs.uk

Locations
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United Kingdom
Leicester General Hospital Recruiting
Leicester, United Kingdom, LE5 4PW
Contact: Jane S Brela    0116 2584408    jane.brela@uhl-tr.nhs.uk   
Contact: Penelope Donley    0116 2584725    penelope.donley@uhl-tr.nhs.uk   
Principal Investigator: Kamlesh Khunti         
Sponsors and Collaborators
University of Leicester
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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT04256720    
Other Study ID Numbers: 0672
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Cardiovascular Diseases
Chronic Pain
Substance-Related Disorders
Personality Disorders
Urologic Diseases
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Renal Insufficiency
Pain
Neurologic Manifestations
Mental Disorders
Chemically-Induced Disorders