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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Loughborough University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Hospitals, Leicester
Information provided by:
Loughborough University
ClinicalTrials.gov Identifier:
NCT01301196
First received: February 22, 2011
Last updated: NA
Last verified: October 2010
History: No changes posted

February 22, 2011
February 22, 2011
October 2010
March 2012   (final data collection date for primary outcome measure)
Sedentary behaviour [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Sedentary behaviour (time < 100 counts/min as assessed by 1-week accelerometry, using the new Actigraph GT3X) at 12 months
Same as current
No Changes Posted
  • Biomarkers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Fasting and 2h glucose, blood lipid profile, insulin, HbA1c, hsCRP, TNFα, IL-6, and IL-6
  • Screen time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    self-reported screen-time (TV, computers, games)
  • Self-reported behaviour [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Time in motorised transport, physical activity (accelerometer and IPAQ questionnaire)
  • Biological measures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Body weight, waist circumference, blood pressure
  • Psychosocial indicators [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Illness perceptions (brief IPQ), efficacy beliefs
Same as current
Not Provided
Not Provided
 
Reducing Sedentary Behaviour in Young Adults at Risk of Diabetes
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Type 2 Diabetes Mellitus
Behavioral: Educational workshop
3h attendance at educational workshop plus self-monitoring
Experimental: Behaviour change
Attendance at 3-h workshop
Intervention: Behavioral: Educational workshop
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
189
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • aged 18-30 years old
  • family history of T2DM or CVD (first degree relative)
  • BMI ≥ 25 (≥ 23 for south Asians)
Both
19 Years to 40 Years
Yes
Not Provided
United Kingdom
 
NCT01301196
MRC 91409
Yes
Stuart Biddle / Professor, Loughborough University
Loughborough University
University Hospitals, Leicester
Not Provided
Loughborough University
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP