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ISRCTN
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ISRCTN61323766
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ClinicalTrials.gov identifier
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Public title
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Trial of efficacy of a family based programme to increase physical activity among individuals at high risk of diabetes
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Scientific title
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Acronym
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ProActive Trial
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Serial number at source
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G0000753
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Study hypothesis
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1. Behaviour change: to estimate the extent to which an innovative approach to increasing physical activity can achieve clinically important changes in a high risk group
2. Disease impact: to model the potential for this behaviour change to reduce the incidence of obesity and diabetes in later life
3. Dose finding: to estimate the effect of delivery of the intervention at two levels of intensity on acceptability, efficacy and costs
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Diabetes
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Participants - inclusion criteria
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Offspring of patients with Type 2 diabetes reporting a sedentary lifestyle.
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Participants - exclusion criteria
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1. Age greater than 30 years, less than 55 years
2. Known diabetes
3. Physical or psychiatric illness limiting programme involvement
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Anticipated start date
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01/04/2001
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Anticipated end date
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31/03/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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365
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Interventions
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Three levels of facilitating physical activity:
1. Face to face of a programme to support motivation, action
2. Telephone delivery and maintenance
3. Comparison group (brief advice by leaflet)
Interventions 1 and 2 are delivered by a facilitator trained in evidence-based methods from psychology.
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Primary outcome measure(s)
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The primary outcome measure is an objective measure of physical activity (PAL), daytime energy expenditure and its ration to basal metabolic rate. Psychological and physiological correlates of this behaviour and costs to the NHS will also be measured.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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Study protocol: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15491494
Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=18177774
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Contact name
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Professor
Ann Louise
Kinmonth
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Address
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Department of Public Health & Primary Care
Institute of Public Health
University of Cambridge Forvie Site
Robinson Way
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City/town
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Cambridge
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Zip/Postcode
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CB2 2SR
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Country
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United Kingdom
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Email
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Sponsor
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Cambridgeshire Support Team (UK)
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Address
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-
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City/town
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-
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Zip/Postcode
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-
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Country
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United Kingdom
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Email
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Date applied
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10/01/2001
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Last edited
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03/03/2008
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Date ISRCTN assigned
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10/01/2001
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