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

Study Overview
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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.

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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Control Group
* Behavioral: Expert-Driven Group
* Behavioral: User-driven group


Participation Criteria
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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 included: 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control group<br>The Control group received limited to general information on blood pressure management | Behavioral: Control Group<br>* Received general information about blood pressure control. All subjects will be sent 16 e-messages on a weekly schedule.<br>|
| Active Comparator: Expert-driven group<br>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). | Behavioral: Expert-Driven Group<br>* 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.<br>|
| Active Comparator: User-driven group<br>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. | Behavioral: User-driven group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure |  | Change from Baseline Systolic Blood Pressure at 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic Blood Pressure |  | Change from Baseline Diastolic Blood Pressure at 4 months | 
| Blood Lipids (HDL, LDL, Cholesterol) |  | Change from Baseline Blood Lipids (HDL, LDL, Cholesterol) at 4 months | 
| Fruit and Vegetables | Diet History Questionaire | Change from Baseline Daily servings of Fruit and Vegetables at 4 months | 
| Daily Steps | Pedometer | Change from Baseline Daily Steps at 4 months |