Clinical trial NCT03111836: Effectiveness of User and Expert Driven Internet-based Lifestyle Interventions on Hypertension Control
Official title: Effectiveness of User and Expert Driven Internet-based Lifestyle Interventions on Hypertension Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 129
Sex: ALL
Minimum age (years): 35
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: Change from Baseline Systolic Blood Pressure at 4 months
Secondary outcomes:
measure: Diastolic Blood Pressure
timeFrame: Change from Baseline Diastolic Blood Pressure at 4 months
measure: Blood Lipids (HDL, LDL, Cholesterol)
timeFrame: Change from Baseline Blood Lipids (HDL, LDL, Cholesterol) at 4 months
measure: Fruit and Vegetables
timeFrame: Change from Baseline Daily servings of Fruit and Vegetables at 4 months
measure: Daily Steps
timeFrame: Change from Baseline Daily Steps at 4 months
Other outcomes:
Locations:
Study officials:
References:
citation: Liu S, Brooks D, Thomas SG, Eysenbach G, Nolan RP. Effectiveness of User- and Expert-Driven Web-based Hypertension Programs: an RCT. Am J Prev Med. 2018 Apr;54(4):576-583. doi: 10.1016/j.amepre.2018.01.009. Epub 2018 Feb 16.