Internet-Based Strategic Transdisciplinary Approach To Risk Reduction And Treatment

Phase 2

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Generic Information; Behavioral: Web-based lifestyle counseling messages

• Registration Number: NCT00815477
• Lead Sponsor: University Health Network, Toronto

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-12-29
• Study First Submitted QC: 2008-12-29
• Study First Posted: 2008-12-30
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-17
• Last Update Posted: 2012-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 387

Inclusion Criteria

• Stage 1 OR Stage 2 hypertension
• 46 -74 years of age
• able to read & write English or French
• living in private residence

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Exclusion Criteria

• Cardiovascular disease
• Major psychiatric disorder (e.g. psychosis)
• Dependence on Alcohol or Drugs with in past year
• Diabetes >= 5 years

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Generic Information	Waitlist control with generic Information about lifestyle and hypertension
2	Web-based lifestyle counseling messages	Web-based intervention of lifestyle counseling messages based on the transtheoretical model of readiness for change.

Primary Outcome Measures

Name	Time	Method
Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure	4 months

Secondary Outcome Measures

Name	Time	Method
Lifestyle Behavior: exercise and diet assessed by questionnaire	4 months
laboratory assessment of estimated vagal-heart rate modulation and baroreflex sensitivity	4 months

Trial Locations

Locations (3)

Grey Bruce Public Health Unit; 🇨🇦 Owen Sound, Ontario, Canada

University of Western Ontario; 🇨🇦 London, Ontario, Canada

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada