Reducing Sedentary Behaviour in Young Adults at Risk of Diabetes

Type 2 Diabetes Mellitus Clinical Trial

— STAND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01301196
• Other study ID #: MRC 91409
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2011
• Last updated: February 22, 2011
• Start date: October 2010
• Est. completion date: March 2012

Study information

• Verified date: October 2010
• Source: Loughborough University
• Contact: n/a
• Is FDA regulated: No
• Health authority: UK: Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 189
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 40 Years

Eligibility

Inclusion Criteria:

• aged 18-30 years old

• family history of T2DM or CVD (first degree relative)

• BMI = 25 (= 23 for south Asians)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Educational workshop
3h attendance at educational workshop plus self-monitoring

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Leicester	Leicester	Leics

Sponsors (2)

Lead Sponsor	Collaborator
Loughborough University	University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedentary behaviour	Sedentary behaviour (time < 100 counts/min as assessed by 1-week accelerometry, using the new Actigraph GT3X) at 12 months	12 months	No
Secondary	Biomarkers	Fasting and 2h glucose, blood lipid profile, insulin, HbA1c, hsCRP, TNFa, IL-6, and IL-6	12 months	No
Secondary	Screen time	self-reported screen-time (TV, computers, games)	12 months	No
Secondary	Self-reported behaviour	Time in motorised transport, physical activity (accelerometer and IPAQ questionnaire)	12 months	No
Secondary	Biological measures	Body weight, waist circumference, blood pressure	12 months	No
Secondary	Psychosocial indicators	Illness perceptions (brief IPQ), efficacy beliefs	12 months	No