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Reducing Sedentary Behaviour in Young Adults at Risk of Diabetes (STAND)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Loughborough University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01301196
First Posted: February 23, 2011
Last Update Posted: February 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospitals, Leicester
Information provided by:
Loughborough University
  Purpose
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.

Condition Intervention
Type 2 Diabetes Mellitus Behavioral: Educational workshop

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: An Intervention to Decrease Sedentary Behaviour in Young Adults at Risk of type2 Diabetes Mellitus - Project STAND

Resource links provided by NLM:


Further study details as provided by Loughborough University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Biomarkers [ Time Frame: 12 months ]
    Fasting and 2h glucose, blood lipid profile, insulin, HbA1c, hsCRP, TNFα, IL-6, and IL-6

  • Screen time [ Time Frame: 12 months ]
    self-reported screen-time (TV, computers, games)

  • Self-reported behaviour [ Time Frame: 12 months ]
    Time in motorised transport, physical activity (accelerometer and IPAQ questionnaire)

  • Biological measures [ Time Frame: 12 months ]
    Body weight, waist circumference, blood pressure

  • Psychosocial indicators [ Time Frame: 12 months ]
    Illness perceptions (brief IPQ), efficacy beliefs


Estimated Enrollment: 189
Study Start Date: October 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behaviour change
Attendance at 3-h workshop
Behavioral: Educational workshop
3h attendance at educational workshop plus self-monitoring

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • aged 18-30 years old
  • family history of T2DM or CVD (first degree relative)
  • BMI ≥ 25 (≥ 23 for south Asians)
  Contacts and Locations
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): NCT01301196


Locations
United Kingdom
University Hospitals of Leicester Recruiting
Leicester, Leics, United Kingdom
Contact: Emma Wilmott, MB ChB       Emma.Wilmot@uhl-tr.nhs.uk   
Sub-Investigator: Stuart Biddle, PhD         
Principal Investigator: Melanie Davies, MD         
Sponsors and Collaborators
Loughborough University
University Hospitals, Leicester
  More Information

Responsible Party: Stuart Biddle / Professor, Loughborough University
ClinicalTrials.gov Identifier: NCT01301196     History of Changes
Other Study ID Numbers: MRC 91409
First Submitted: February 22, 2011
First Posted: February 23, 2011
Last Update Posted: February 23, 2011
Last Verified: October 2010

Keywords provided by Loughborough University:
sedentary behaviour
diabetes
structured education
18-30 years olds
family history of T2DM or CVD
BMI ≥ 25 (≥23 for south Asians)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases