Clinical trial NCT01301196: Reducing Sedentary Behaviour in Young Adults at Risk of Diabetes
Official title: An Intervention to Decrease Sedentary Behaviour in Young Adults at Risk of type2 Diabetes Mellitus - Project STAND
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: sedentary behaviour
diabetes
structured education
18-30 years olds
family history of T2DM or CVD
BMI ≥ 25 (≥23 for south Asians)
Lead sponsor: Loughborough University
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
First posted: 2011-02-23
Enrollment: 189
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Sedentary behaviour
timeFrame: 12 months
Secondary outcomes:
measure: Biomarkers
timeFrame: 12 months
measure: Screen time
timeFrame: 12 months
measure: Self-reported behaviour
timeFrame: 12 months
measure: Biological measures
timeFrame: 12 months
measure: Psychosocial indicators
timeFrame: 12 months
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
state: Leics
Study officials:
References: