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Internet-Based Strategic Transdisciplinary Approach To Risk Reduction And Treatment

NCT00815477 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2012-02-20

No results posted yet for this study

Summary

I-START is a randomized controlled trial that will evaluate the efficacy of an internet-based program of behavioural counseling for adaptive lifestyle change to subjects diagnosed with hypertension. I-START will be evaluated using objective outcome indices: systolic and diastolic blood pressure, pulse pressure, and markers of vagal-heart rate (HR) modulation and baroreflex sensitivity. The Heart and Stroke Foundation of Canada "Blood Pressure Action Plan(TM)" (BPAP) will be adminisered over a 4-month period, and evaluated in a 2 (Intervention vs. Wait list Control) X 2 (Baseline vs. Post-Intervention) factorial design, blocking for 3 recruitment sites (Toronto, London, the Grey Bruce region of Ontario, Canada), and stratified for sex and age group (45-59, 60-74 years).

Conditions

Interventions

BEHAVIORAL

Web-based lifestyle counseling messages

10 email messages based on readiness-to-change over a 4 month period

BEHAVIORAL

Generic Information

Waitlist control plus educational material on lifestyle behavior and hyptertension

Sponsors & Collaborators

  • Canadian Stroke Network

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Robert P Nolan, Ph.D. · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
46 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00815477 on ClinicalTrials.gov