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Clinical Trials/NCT01301196
NCT01301196UnknownNot Applicable

An Intervention to Decrease Sedentary Behaviour in Young Adults at Risk of type2 Diabetes Mellitus - Project STAND

Loughborough University1 site in 1 country189 target enrollmentStarted: October 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
189
Locations
1
Primary Endpoint
Sedentary behaviour

Study Overview

Brief Summary

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Investigator)

Eligibility Criteria

Ages
19 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Behaviour change

Experimental

Attendance at 3-h workshop

Intervention: Educational workshop (Behavioral)

Outcomes

Primary Outcomes

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 Outcomes

  • Biomarkers(12 months)
  • Screen time(12 months)
  • Self-reported behaviour(12 months)
  • Biological measures(12 months)
  • Psychosocial indicators(12 months)

Investigators

Sponsor Class
Other

Study Sites (1)

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