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

University of Toronto

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Control Group; Behavioral: Expert-Driven Group; Behavioral: User-driven group

Study type: Interventional

Funder types: Other

Identifiers

NCT03111836

UT01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 35 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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129 participants in 3 patient groups

Control group

Sham Comparator group

Description:

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

Treatment:

Behavioral: Control Group

Expert-driven group

Active Comparator group

Description:

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).

Treatment:

Behavioral: Expert-Driven Group

User-driven group

Active Comparator group

Description:

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.

Treatment:

Behavioral: User-driven group