Condition category
Circulatory System
Date applied
11/12/2007
Date assigned
19/12/2007
Last edited
11/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robert Petrella

ORCID ID

Contact details

Parkwood Hospital
Room B3002
801 Commissioners Rd. E
London
N6C 5J1
Canada
petrella@uwo.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SNAC

Study hypothesis

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

Ethics approval received from the Research Ethics Board of The University of Western Ontario on the 22nd April 2003 (review #: 09572).

Study design

Randomised prospective design.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

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 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).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Improvements in exercise capacity, left ventricular diastolic function (E/A ratio), and brachial artery endothelial function, measured at V1 - V5 (see interventions).

Secondary outcome measures

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

Overall trial start date

01/01/2004

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant 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

Recruitment start date

01/01/2004

Recruitment end date

30/06/2006

Locations

Countries of recruitment

Canada

Trial participating centre

Parkwood Hospital, Room B3002
London
N6C 5J1
Canada

Sponsor information

Organisation

Lawson Health Research Institute (Canada)

Sponsor details

801 Commissioners Rd. E
London
N6C 5J1
Canada
info@lhrionhealth.ca

Sponsor type

Research organisation

Website

http://www.lhrionhealth.ca/LHRI/index.html

Funders

Funder type

Research organisation

Funder name

Heart and Stroke Foundation of Ontario (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21324150

Publication citations

  1. Protocol

    Petrella RJ, Aizawa K, Shoemaker K, Overend T, Piche L, Marin M, Shapiro S, Atkin S, Efficacy of a family practice-based lifestyle intervention program to increase physical activity and reduce clinical and physiological markers of vascular health in patients with high normal blood pressure and/or high normal blood glucose (SNAC): study protocol for a randomized controlled trial., Trials, 2011, 12, 45, doi: 10.1186/1745-6215-12-45.

Additional files

Editorial Notes