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Reducing Sedentary Behaviour in Young Adults at Risk of Diabetes (STAND)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Educational workshop
Sponsored by
Loughborough University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring sedentary behaviour, diabetes, structured education, 18-30 years olds, family history of T2DM or CVD, BMI ≥ 25 (≥23 for south Asians)

Eligibility Criteria

19 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • University Hospitals of LeicesterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Behaviour change

Arm Description

Attendance at 3-h workshop

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 22, 2011
Last Updated
February 22, 2011
Sponsor
Loughborough University
Collaborators
University Hospitals, Leicester
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1. Study Identification

Unique Protocol Identification Number
NCT01301196
Brief Title
Reducing Sedentary Behaviour in Young Adults at Risk of Diabetes
Acronym
STAND
Official Title
An Intervention to Decrease Sedentary Behaviour in Young Adults at Risk of type2 Diabetes Mellitus - Project STAND
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Loughborough University
Collaborators
University Hospitals, Leicester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
189 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behaviour change
Arm Type
Experimental
Arm Description
Attendance at 3-h workshop
Intervention Type
Behavioral
Intervention Name(s)
Educational workshop
Intervention Description
3h attendance at educational workshop plus self-monitoring
Primary Outcome Measure Information:
Title
Sedentary behaviour
Description
Sedentary behaviour (time < 100 counts/min as assessed by 1-week accelerometry, using the new Actigraph GT3X) at 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Biomarkers
Description
Fasting and 2h glucose, blood lipid profile, insulin, HbA1c, hsCRP, TNFα, IL-6, and IL-6
Time Frame
12 months
Title
Screen time
Description
self-reported screen-time (TV, computers, games)
Time Frame
12 months
Title
Self-reported behaviour
Description
Time in motorised transport, physical activity (accelerometer and IPAQ questionnaire)
Time Frame
12 months
Title
Biological measures
Description
Body weight, waist circumference, blood pressure
Time Frame
12 months
Title
Psychosocial indicators
Description
Illness perceptions (brief IPQ), efficacy beliefs
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aged 18-30 years old family history of T2DM or CVD (first degree relative) BMI ≥ 25 (≥ 23 for south Asians)
Facility Information:
Facility Name
University Hospitals of Leicester
City
Leicester
State/Province
Leics
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Wilmott, MB ChB
Email
Emma.Wilmot@uhl-tr.nhs.uk
First Name & Middle Initial & Last Name & Degree
Stuart Biddle, PhD
First Name & Middle Initial & Last Name & Degree
Melanie Davies, MD

12. IPD Sharing Statement

Learn more about this trial

Reducing Sedentary Behaviour in Young Adults at Risk of Diabetes

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