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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Control Group; Behavioral: Expert-Driven Group; Behavioral: User-driven group

• Registration Number: NCT03111836
• Lead Sponsor: University of Toronto

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-06-01
• Primary Completion: 2014-07-01
• Study Completion: 2015-06-01
• Status Verified: 2017-04
• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-07
• Last Update Submitted: 2017-04-07
• Study First Posted: 2017-04-13
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control Group	The Control group received limited to general information on blood pressure management
Expert-driven group	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).
User-driven group	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.

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	Change from Baseline Systolic Blood Pressure at 4 months

Secondary Outcome Measures

Name	Time	Method
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	Change from Baseline Daily servings of Fruit and Vegetables at 4 months	Diet History Questionaire
Daily Steps	Change from Baseline Daily Steps at 4 months	Pedometer