Internet-Based Strategic Transdisciplinary Approach To Risk Reduction And Treatment

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00815477

Acronym

I-START

Enrollment

387

Registered

2008-12-30

Start date

2007-09-30

Completion date

2009-12-31

Last updated

2012-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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).

Interventions

BEHAVIORALWeb-based lifestyle counseling messages

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

BEHAVIORALGeneric Information

Waitlist control plus educational material on lifestyle behavior and hyptertension

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

46 Years to 74 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure	4 months

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026