NCT00473785

Brief Summary

The purpose of this study is to provide lifestyle counselling for protective health behavior (exercise, diet, smoking cessation) to small groups (6-8 subjects) via teleconference. The sample includes individuals at elevated risk for cardiovascular disease (CVD) as well as individuals with established CVD. Our hypothesis is that telephone-based lifestyle counselling will (1) significantly increase protective lifestyle behavior (diet, exercise, smoke-free living) and (2) significantly reduce CVD risk factors at 6-month follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
827

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2007

Completed
Last Updated

May 15, 2007

Status Verified

May 1, 2007

First QC Date

May 11, 2007

Last Update Submit

May 14, 2007

Conditions

Keywords

Cardiovascular diseasePreventionLifestyle

Outcome Measures

Primary Outcomes (1)

  • Psychometric assessment of change in exercise, diet and smoking

    Post-treatment and 6-month follow-up

Secondary Outcomes (2)

  • SBP, DBP, total cholesterol, HDL, LDL, triglycerides and 10-year absolute CVD risk

    6-month follow-up

  • Psychometric assessment of symptoms of depression, psychological stress, and social support.

    post-treatment and 6-month follow-up

Interventions

Eligibility Criteria

Age35 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 74 years of age,
  • Diagnosis of CVD or Type 1 or 2 diabetes, or
  • ≥2 of the following CVD risk factors:
  • Confirmed diagnosis of hypertension,
  • Dyslipidemia,
  • Males aged ≥55 years/females aged ≥60 years,
  • Family history of CHD or stroke;
  • Current smoker, or
  • BMI ≥ 27.

You may not qualify if:

  • Diagnosis of clinically significant cardiac complications (e.g. arrhythmia, unstable angina) or a congenital cardiac condition;
  • Major psychiatric illness (e.g. psychosis), history of alcohol or drug dependence within the previous year, or residence in a non-private setting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Laurentian University / Sudbury and District Health Unit

Greater Sudbury, Ontario, P3E 2C6, Canada

Location

Grey-Bruce Health Unit

Owen Sound, Ontario, N4K 4K5, Canada

Location

University Health Network / Sunnybrook and Women's College Health Sciences Centre

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (1)

  • Grace SL, Barry-Bianchi S, Stewart DE, Rukholm E, Nolan RP. Physical activity behavior, motivational readiness and self-efficacy among Ontarians with cardiovascular disease and diabetes. J Behav Med. 2007 Feb;30(1):21-9. doi: 10.1007/s10865-006-9080-5. Epub 2006 Nov 16.

    PMID: 17109217BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Robert P Nolan, PhD

    University Health Network/University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 11, 2007

First Posted

May 15, 2007

Study Start

January 1, 2002

Study Completion

December 1, 2005

Last Updated

May 15, 2007

Record last verified: 2007-05

Locations