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Completed

NCT Number: NCT00815477

Internet-Based Strategic Transdisciplinary Approach To Risk Reduction And Treatment

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).

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

46 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Western Ontario, London, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Web-based lifestyle counseling messages

Behavioral

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

Generic Information

Behavioral

Waitlist control plus educational material on lifestyle behavior and hyptertension

Primary outcomes

  1. Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure

    Time frame: 4 months

Secondary outcomes

  1. Lifestyle Behavior: exercise and diet assessed by questionnaire

    Time frame: 4 months

  2. laboratory assessment of estimated vagal-heart rate modulation and baroreflex sensitivity

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Canadian Stroke Network

Registry information

Official study title

I-START: Internet-based Strategic Transdisciplinay Approach to Risk Reduction And Treatment

Acronym: I-START

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 30, 2008
Registry last updated
Feb 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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