NCT01043770

Brief Summary

The aim of our study is to see if people with metabolic syndrome who attend a group education programme based on lifestyle changes (dietary and increased physical activity) can lessen their risk of having diabetes, heart disease and strokes in the future.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 30, 2020

Status Verified

December 1, 2011

Enrollment Period

2 years

First QC Date

January 6, 2010

Last Update Submit

January 29, 2020

Conditions

Metabolic Syndrome

Keywords

Metabolic syndromePrimary preventionDiabetesCardiovascular diseasePatient education

Outcome Measures

Primary Outcomes (1)

  • The proportion of people in the intervention and control groups with prevalent metabolic syndrome according to the IDF criteria.

    12 months follow-up.

Secondary Outcomes (9)

  • The prevalence of metabolic syndrome according to NCEP criteria

    Compared at baseline versus 12 months, and for the intervention group versus the control group

  • Changes in individual components of the metabolic syndrome (fasting plasma glucose, triglycerides, HDL cholesterol, blood pressure, waist circumference), and 2 hour glucose

    Compared at baseline versus 12 months, and for the intervention group versus the control group

  • Changes in biomarkers (hs-CRP, adiponectin, and insulin)

    Compared at baseline versus 12 months, and for the intervention group versus the control group

  • Changes in physical activity as measured by IPAQ and pedometer

    Compared at baseline versus 12 months, and for the intervention group versus the control group

  • Changes in dietary/nutritional intake measured by DINE

    Compared at baseline versus 12 months, and for the intervention group versus the control group

  • +4 more secondary outcomes

Study Arms (2)

Group lifestyle education

EXPERIMENTAL

Multi-component behaviour change intervention

Behavioral: Group lifestyle education

Routine care

NO INTERVENTION

Routine care

Interventions

Group lifestyle educationBEHAVIORAL

Structured group education programme based on lifestyle changes (dietary and increased physical activity)

Group lifestyle education

Eligibility Criteria

Age40 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 40 - 74 years inclusive
  • Registered with a general practice in Leicester City or Leicester County Primary Care Trust
  • Availability of data to allow diagnosis of MetS (IDF criteria) collected at a screening visit

You may not qualify if:

  • Previous diagnosis of T2DM, CVD (stroke/cerebrovascular accident, transient ischaemic attack), peripheral arterial disease, or coronary heart disease (angina, myocardial infarction, coronary artery bypass surgery, angioplasty)
  • Life-limiting terminal illness
  • Pregnancy and/or breast feeding
  • Lack of capacity to give informed consent because of serious mental health problems or learning disability.
  • People who are housebound
  • Patients residing in nursing/care homes
  • Individuals who are unable to speak and understand English. (The intervention will be made appropriate for ethnically diverse populations, but individuals who are unable to understand, speak and read English will be excluded at this stage. However, if the self-management programme is found to be successful we would adapt it for non-English speakers.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leicester

Leicester, LE9 6PE, United Kingdom

Location

Related Publications (1)

  • Dunkley AJ, Davies MJ, Stone MA, Taub NA, Troughton J, Yates T, Khunti K. The Reversal Intervention for Metabolic Syndrome (TRIMS) study: rationale, design, and baseline data. Trials. 2011 May 4;12:107. doi: 10.1186/1745-6215-12-107.

    PMID: 21542913RESULT

MeSH Terms

Conditions

Metabolic SyndromeDiabetes MellitusCardiovascular Diseases

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kamlesh Khunti, MD, FRCGP

    Diabetes Research Centre, University of Leicester

    PRINCIPAL INVESTIGATOR

  • Melanie J Davies, MD, FRCP

    Diabetes Research Centre, University of Leicester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 7, 2010

Study Start

August 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 30, 2020

Record last verified: 2011-12

Locations

GB(1)