Effectiveness of User and Expert Driven Internet-based Lifestyle Interventions on Hypertension Control

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-01

Study Completion Date

2015-06-01

Brief Summary

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Hypertension is a leading risk factor for cardiovascular disease and mortality. Lifestyle counseling is recommended as a first line therapy for reducing blood pressure (BP) and risk for cardiovascular events. Recent studies suggest that e-based lifestyle interventions are effective in evoking therapeutic change in BP1. However, BP response and adherence to exercise and diet behavior varies significantly after e-based interventions due to variations in treatment methodologies. Consensus is not yet established for a standardized e-counseling protocol for hypertension. As noted in our systematic review, the two dominant models of e-counseling procedures are expert-driven (protocol driven, prescriptive) and user-driven (self-guided, collaborative). Expert-driven programs prescribe specific changes for lifestyle behavior which are intended to facilitate compliance to behavioral change. In contrast, the user-driven method actively involves the subject in goal-setting and/or the selection of the intervention used to reach the behavioral goal. One conclusion from the systematic review is that these models are used indiscriminately in e-counseling programs. There is currently inadequate data to determine the efficacy of programs that are expert-driven vs. user-driven in reducing BP while modifying lifestyle behaviour. It is possible that a combination of expert-driven and user-driven features for lifestyle e-counseling is most effective. However, before these two approaches can be combined, it is essential to establish the strengths and limitations of each model.

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Detailed Description

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This study will use a 3-parallel group, randomized controlled design: 3 (Groups: Control, expert-driven, and user-driven e-Counselling) by 2 (Assessments: baseline, 4-month). Controls will receive general e-information on BP management. The expert-driven e-Counselling group will provide a prescribed exercise and a diet plan. The user-driven e-Counselling group will a program that enables the patient to choose areas of focus. All subjects will be sent 16 e-messages on a weekly schedule.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control group

The Control group received limited to general information on blood pressure management

Group Type SHAM_COMPARATOR

Control Group

Intervention Type BEHAVIORAL

Received general information about blood pressure control. All subjects will be sent 16 e-messages on a weekly schedule.

Expert-driven group

The intervention will consisted of pre-determined exercise and dietary goals (e.g. increase daily steps by 1000 steps, consuming 2-3 servings of fruit and vegetables per day).

Group Type ACTIVE_COMPARATOR

Expert-Driven Group

Intervention Type BEHAVIORAL

The user-driven e-Counselling group will receive a lifestyle program where the user are able to choose areas of focus. All subjects will be sent 16 e-messages on a weekly schedule.

User-driven group

The User-driven group received an intervention that enabled participants to select their areas of lifestyle change using text and video web links embedded in the email. The trans-theoretical model was used to inform the design of the User-driven program.

Group Type ACTIVE_COMPARATOR

User-driven group

Intervention Type BEHAVIORAL

The user-driven e-Counselling group will receive a lifestyle program where the user are able to choose areas of focus. All subjects will be sent 16 e-messages on a weekly schedule.

Interventions

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Control Group

Received general information about blood pressure control. All subjects will be sent 16 e-messages on a weekly schedule.

Intervention Type BEHAVIORAL

Expert-Driven Group

The user-driven e-Counselling group will receive a lifestyle program where the user are able to choose areas of focus. All subjects will be sent 16 e-messages on a weekly schedule.

Intervention Type BEHAVIORAL

User-driven group

The user-driven e-Counselling group will receive a lifestyle program where the user are able to choose areas of focus. All subjects will be sent 16 e-messages on a weekly schedule.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Unchanged prescription for anti-hypertensive medication at least 2 months before enrollment.
* Participants prescribed antihypertensive medication were also required to have SBP ≥130 mmHg and/or DBP ≥85 mmHg, in order to prevent "floor effects".

Exclusion Criteria

* Diagnosis of kidney disease, major psychiatric illness (e.g. psychosis), alcohol or drug dependence in the previous year, pregnancy and sleep apnea. There was no racial or gender bias in the selection of participants.

Minimum Eligible Age

35 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No