Reducing Sedentary Behaviour in Young Adults at Risk of Diabetes

NCT ID: NCT01301196

Last Updated: 2011-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-03-31

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Behaviour change

Attendance at 3-h workshop

Group Type: EXPERIMENTAL

Educational workshop

Intervention Type: BEHAVIORAL

3h attendance at educational workshop plus self-monitoring

Interventions

Educational workshop

3h attendance at educational workshop plus self-monitoring

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals, Leicester

OTHER

Sponsor Role: collaborator

Loughborough University

OTHER

Sponsor Role: lead

Responsible Party

Loughborough University

Locations

University Hospitals of Leicester

Leicester, Leics, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Emma Wilmott, MB ChB

Role: primary

Emma.Wilmot@uhl-tr.nhs.uk

Other Identifiers

MRC 91409

Identifier Type: -

Identifier Source: org_study_id