NCT02551926

Brief Summary

Prehypertension is a predisposing condition for morbidity inhypertension and cardiovascular diseases. Health education via electronic pathways such as mobile text messaging or virtual communities may provide more availability and adherence than printed media. Regarding lower costs of such electronic resources and continuity of interventions through these ways, assessing their effectiveness compared to a printed material may help health educators to choose proper methods for improve their educational attempts. Therefore, the current study aims to compare different tools for health education about healthy lifestyle in people with prehypertension. For this, educational interventions with similar content among 3 groups of people will be conducted (i.e., first group via mobile text messaging, second group using virtual communities, and third group by brochures as a printed media). A control group also will be considered without any intervention. Several phases are considered in the study. In phase 1 using health centers located in Qazvin city, people would be invited to a free screening program of prehypertension. Then, an eligible sample will be divided in three groups using a random allocation process (each one including 100-150 people with prehypertension). The blood pressure and health promotion lifestyle profile II (HPLP II) will be measured before intervention. A standard educational content using approaches of lifestyle promotion defined in HPLP II would be available for intervention groups during a time period of 1 month concurrently. At final phase, one month after termination of intervention blood pressure as primary outcome and lifestyle changes along with self-efficacy for lifestyle modification as secondary outcomes will be measured. This study may suggest effective ways for health education which is applicable by health care professionals to promote health status among peopleat risk of hypertension.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 16, 2015

Status Verified

September 1, 2015

Enrollment Period

4 months

First QC Date

August 27, 2015

Last Update Submit

September 15, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Changes from baseline and 1 Months after the intervention

Secondary Outcomes (3)

  • changes in self-reported physical activity

    Changes from baseline and 1 Months after the intervention

  • Changes in self-reported healthy eating

    Changes from baseline and 1 Months after the intervention

  • Changes in self-reported Self-efficacy

    Changes from baseline and 1 Months after the intervention

Study Arms (4)

mobile text messaging

EXPERIMENTAL

Patients will receive some SMS in a regular interval.

Behavioral: mobile text messagesDevice: mobile phone

virtual communities

EXPERIMENTAL

Patients will receive some messages by a virtual community in a regular interval.

Behavioral: virtual community

brochures

EXPERIMENTAL

Patients will receive some messages by as a printed media

Behavioral: brochures

Control

ACTIVE COMPARATOR

control group will be included without any intervention

Other: Usual care

Interventions

mobile text messaging
virtual communities
brochuresBEHAVIORAL
brochures
Control
mobile text messaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be \>18 years
  • have a diagnosis of prehypertension based on definition
  • own a cell phone capable of receiving and sending text messages
  • be a member of virtual communities
  • Persian speaking
  • willing to attend two data collection visits in Qazvin

You may not qualify if:

  • admits to planning to terminate cell phone contract or excite form virtual communities during the next one month
  • education less than primary school
  • other major health problems (e.g., terminal stage of cancer, advanced liver disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

22 Bahman Hospital

Qazvin, Qazvin Province, 3419759811, Iran

RECRUITING

Qazvin University of Medical Sciences, Shahid Rajaei Hospital

Qazvin, Qazvin Province, Iran

RECRUITING

MeSH Terms

Conditions

HypertensionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ِDirector of SDH center

Study Record Dates

First Submitted

August 27, 2015

First Posted

September 16, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 16, 2015

Record last verified: 2015-09

Locations