Effectiveness of User and Expert Driven Internet-based Lifestyle Interventions on Hypertension Control
1 other identifier
interventional
129
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Jun 2012
Typical duration for not_applicable hypertension
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 4, 2017
CompletedFirst Posted
Study publicly available on registry
April 13, 2017
CompletedApril 13, 2017
April 1, 2017
2.1 years
April 4, 2017
April 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Systolic Blood Pressure
Change from Baseline Systolic Blood Pressure at 4 months
Secondary Outcomes (4)
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
Daily Steps
Change from Baseline Daily Steps at 4 months
Study Arms (3)
Control group
SHAM COMPARATORThe Control group received limited to general information on blood pressure management
Expert-driven group
ACTIVE COMPARATORThe 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
ACTIVE COMPARATORThe 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.
Interventions
Received general information about blood pressure control. All subjects will be sent 16 e-messages on a weekly schedule.
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.
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.
Eligibility Criteria
You may qualify if:
- 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".
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29456025DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
April 4, 2017
First Posted
April 13, 2017
Study Start
June 1, 2012
Primary Completion
July 1, 2014
Study Completion
June 1, 2015
Last Updated
April 13, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share