Reducing Sedentary Behaviour in Young Adults at Risk of Diabetes

Not Applicable

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: Educational workshop

• Registration Number: NCT01301196
• Lead Sponsor: Loughborough University

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 Timeline

• Status Verified: 2010-10
• Study Start: 2010-10
• Study First Submitted: 2011-02-22
• Study First Submitted QC: 2011-02-22
• Last Update Submitted: 2011-02-22
• Study First Posted: 2011-02-23
• Last Update Posted: 2011-02-23
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 189

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behaviour change	Educational workshop	Attendance at 3-h workshop

Primary Outcome Measures

Name	Time	Method
Sedentary behaviour	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

Name	Time	Method
Biomarkers	12 months	Fasting and 2h glucose, blood lipid profile, insulin, HbA1c, hsCRP, TNFα, IL-6, and IL-6
Screen time	12 months	self-reported screen-time (TV, computers, games)
Self-reported behaviour	12 months	Time in motorised transport, physical activity (accelerometer and IPAQ questionnaire)
Biological measures	12 months	Body weight, waist circumference, blood pressure
Psychosocial indicators	12 months	Illness perceptions (brief IPQ), efficacy beliefs

Trial Locations

Locations (1)

University Hospitals of Leicester; 🇬🇧 Leicester, Leics, United Kingdom