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

February 22, 2011 updated by: Loughborough University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Leics
      • Leicester, Leics, United Kingdom
        • Recruiting
        • University Hospitals of Leicester
        • Contact:
        • Sub-Investigator:
          • Stuart Biddle, PhD
        • Principal Investigator:
          • Melanie Davies, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loughborough University

Collaborators

University Hospitals, Leicester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

February 22, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (Estimate)

February 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 23, 2011

Last Update Submitted That Met QC Criteria

February 22, 2011

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC 91409

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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