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ISRCTN
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ISRCTN42921300
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ClinicalTrials.gov identifier
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Public title
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Staged Nutrition and Activity Counselling (SNAC) interventions that prime targeted antihypertensive therapy to prevent cardiovascular outcomes in the primary care setting
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Scientific title
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Acronym
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SNAC
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Serial number at source
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N/A
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Study hypothesis
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Improved lifestyle behaviour would enhance cardiac function, vascular elastic properties, and conduit vessel endothelial function with important benefits to clinical outcome measures and exercise perturbations to the cardiovascular system.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Ethics approval received from the Research Ethics Board of The University of Western Ontario on the 22nd April 2003 (review #: 09572).
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Study design
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Randomised prospective design.
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Countries of recruitment
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Canada
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Disease/condition/study domain
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High-normal blood pressure and/or impaired glucose regulation.
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Participants - inclusion criteria
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1. Men and women aged 40 - 85 years who are able to provide informed consent
2. Presence of high-normal blood pressure, impaired fasting glucose, impaired glucose tolerance, or all of them
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Participants - exclusion criteria
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1. Unstable cardiovascular or metabolic disease
2. Previous diagnosis of hypertension or type 2 diabetes
3. Myocardial infarction, coronary artery bypass, or cerebrovascular ischaemia/stroke (including Transient Ischaemic Attack [TIA]) within 3 months prior to study
4. History of alcoholism, drug abuse, or other emotional, cognitive or psychiatric problems that are likely to limit compliance to the study
5. Pacemaker
6. Already enrolled in a clinical research trial
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Anticipated start date
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01/01/2004
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Anticipated end date
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30/06/2006
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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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300
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Interventions
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Subjects were randomly assigned to either the SNAC intervention group or the usual care group.
The SNAC intervention group received the SNAC lifestyle intervention that combined the STEP test and exercise prescription with a version of Canada’s Food Guide adapted to suit a Mediterranean-style diet. The SNAC lifestyle intervention was delivered according to Procheska and Declemente’s Transtheoretical Model, and delivered by each subject’s family physician. To optimise familiarisation with the diet and facilitate long-term adherence, during first 8 weeks, subjects received one dinner meal per day (5 meals per week) from the laboratory as well as sample menus for breakfast and lunch. From the week 9, subjects received only sample menus for all meals.
The usual care group received "usual care" blood pressure and plasma glucose management from their family physician (for example, family physicians in this group delivered lifestyle advise to subjects as the way they normally did).
All assessments were conducted at baseline (V1), week 8 (V2), week 16 (V3), week 24 (V4), and week 52 (V5).
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Primary outcome measure(s)
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Improvements in exercise capacity, left ventricular diastolic function (E/A ratio), and brachial artery endothelial function, measured at V1 - V5 (see interventions).
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Secondary outcome measure(s)
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1. Caloric profile and anthropometrics, measured at V1 - V5 (see interventions)
2. Resting blood pressure and 24-hour ambulatory blood pressure, measured at V1 - V5
3. Blood chemistries (glucose, lipids, catecholamines, HbA1c, etc), measured at V1 - V5
4. Muscle sympathetic nerve activity, measured at V1 - V5
5. Geometry and elastic properties of the carotid artery, and geometry of left ventricle, measured at V1 - V5
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Sources of funding
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Heart and Stroke Foundation of Ontario (Canada)
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Trial website
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Publications
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1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21324150
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Contact name
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Dr
Robert
Petrella
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Address
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Parkwood Hospital, Room B3002
801 Commissioners Rd. E
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City/town
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London
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Zip/Postcode
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N6C 5J1
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Country
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Canada
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Email
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petrella@uwo.ca
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Sponsor
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Lawson Health Research Institute (Canada)
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Address
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801 Commissioners Rd. E
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City/town
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London
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Zip/Postcode
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N6C 5J1
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Country
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Canada
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Email
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info@lhrionhealth.ca
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Sponsor website:
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http://www.lhrionhealth.ca/LHRI/index.html
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Date applied
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11/12/2007
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Last edited
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11/01/2012
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Date ISRCTN assigned
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19/12/2007
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