Reducing Sedentary Behaviour in Young Adults at Risk of Diabetes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Educational workshop


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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behaviour change<br>Attendance at 3-h workshop | Behavioral: Educational workshop<br>* 3h attendance at educational workshop plus self-monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedentary behaviour | Sedentary behaviour (time < 100 counts/min as assessed by 1-week accelerometry, using the new Actigraph GT3X) at 12 months | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedentary behaviour, diabetes, structured education, 18-30 years olds, family history of T2DM or CVD, BMI ≥ 25 (≥23 for south Asians)