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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Parkwood Hospital, Room B3002
801 Commissioners Rd. E
London
N6C 5J1
Canada
| petrella@uwo.ca |
Study information
| Study design | Randomised prospective design. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| 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 | 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 study start date | 01/01/2004 |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
N6C 5J1
Canada
Sponsor information
Lawson Health Research Institute (Canada)
Research organisation
Research organisation
801 Commissioners Rd. E
London
N6C 5J1
Canada
| info@lhrionhealth.ca | |
| Website | http://www.lhrionhealth.ca/LHRI/index.html |
"ROR" |
https://ror.org/051gsh239 |
Funders
Funder type
Research organisation
Heart and Stroke Foundation of Ontario (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
