Staged Nutrition and Activity Counselling (SNAC) interventions that prime targeted antihypertensive therapy to prevent cardiovascular outcomes in the primary care setting

ISRCTN	ISRCTN42921300
DOI	https://doi.org/10.1186/ISRCTN42921300
Protocol serial number	N/A
Sponsor	Lawson Health Research Institute (Canada)
Funder	Heart and Stroke Foundation of Ontario (Canada)

Submission date: 11/12/2007
Registration date: 19/12/2007
Last edited: 31/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Robert Petrella
Scientific

Parkwood Hospital, Room B3002
801 Commissioners Rd. E
London
N6C 5J1
Canada

Email	petrella@uwo.ca

Study information

Primary study design	Interventional
Study design	Randomised prospective design.
Secondary study design	Randomised controlled trial
Scientific title	Staged Nutrition and Activity Counselling (SNAC) interventions that prime targeted antihypertensive therapy to prevent cardiovascular outcomes in the primary care setting
Study acronym	SNAC
Study objectives	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.
Ethics approval(s)	Ethics approval received from the Research Ethics Board of The University of Western Ontario on the 22nd April 2003 (review #: 09572).
Health condition(s) or problem(s) studied	High-normal blood pressure and/or impaired glucose regulation.
Intervention	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 Canadas Food Guide adapted to suit a Mediterranean-style diet. The SNAC lifestyle intervention was delivered according to Procheska and Declementes Transtheoretical Model, and delivered by each subjects 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).
Intervention type	Other
Primary outcome measure(s)	Improvements in exercise capacity, left ventricular diastolic function (E/A ratio), and brachial artery endothelial function, measured at V1 - V5 (see interventions).
Key secondary outcome measure(s)	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
Completion date	30/06/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	300
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	01/01/2004
Date of final enrolment	30/06/2006

Locations

Countries of recruitment

Canada

Study participating centre

Parkwood Hospital, Room B3002

London
N6C 5J1
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	16/02/2011		Yes	No

Editorial Notes

31/12/2020: No publications found, verifying study status with principal investigator.