Protocol summary

Summary
This study is an interactive web-based randomized trial on 160 people with metabolic syndrome in Tehran. The aim of this parallel randomized controlled trial is comparison the effectiveness of an interactive web-based lifestyle intervention focusing on dietary and physical activity for reducing metabolic syndrome indicators. A website namely Healthy Heart Education (http://www.Heartresearch.ir) is designed in order to increase knowledge of visitors about cardiovascular diseases risk factors and attract the attention for metabolic syndrome. Participants enrolled to the study by registering on the website and completing information including: name, age, gender, weight, height, waist circumference, phone number, living home addresses. Participants who meet the study criteria contacted and invited for the study. Randomization carried out after baseline measurements. Participants randomly assigned to two arms. All participants received information on dietary intake and physical activity through the study website. The intervention group received additional resources via the study website including interactive Healthy Heart Profile and calorie restricted diet tailored to the participants. Participants in the intervention group receive username and password to use the Healthy Heart Profile program. The primary outcome is to detect differences in metabolic syndrome between the intervention and the control group. The secondary outcomes are comparing quality of life, physical activity and food intake among the study arms. The participants followed up for 6 months with data collection scheduled at baseline, 3 and 6 months. Anthropometric and clinical measures were (weight, waist circumference, BMI and blood pressure, Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, Fasting blood glucose.

General information

Acronym
Red Ruby Study
IRCT registration information
IRCT registration number: IRCT201111198132N1
Registration date: 2013-05-27, 1392/03/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-05-27, 1392/03/06
Registrant information
Name
Leila Jahangiry
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 307 0128
Email address
jahangiry@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-09-10, 1391/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness comparison of an interactive web-based intervention for lifestyle modification on metabolic syndrome
Public title
Interactive web-based intervention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Waist circumference, men and women equal or more than 90; Blood pressure equal or more than 130/85; Access to internet; having simple skills to work with the Internet; Informed consent Exclusion criteria:having history of cardiovascular diseases; diabetics; having cancer; patients with renal diseases; being peragnant; taking medication for high blood pressure; taking medication for dislipidemia.
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University Of Medical Sciences
Street address
Tehran university Of Medical sciences, Enqelab Avenue, Tehran
City
Tehran
Postal code
0098
Approval date
2011-11-16, 1390/08/25
Ethics committee reference number
15287

Health conditions studied

1

Description of health condition studied
Metabolic syndrome disorders
ICD-10 code
E88.9
ICD-10 code description
Metabolic disorder, unspecified

Primary outcomes

1

Description
waist circumference
Timepoint
0, 3, 6 month
Method of measurement
cm

Secondary outcomes

1

Description
Nutrition and physical activity
Timepoint
3, 6 after baseline measurment
Method of measurement
questionaire

Intervention groups

1

Description
Educational intervention be done through website on healthy nutrition and physical activity. intervention group can use of educational materials on the site and take self monitoring tools for cardiovascular risk assessment, time of the study take 6 month.
Category
Lifestyle

2

Description
Control receive educational materials by emails every 3 week.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Heart center, Tehran University of Medical Sciences
Full name of responsible person
Dr.Mehdi Najafi
Street address
Tehran Heart Center,Nourth Kargar Street, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Esmaeil Shojae zade
Street address
Public Health Faculty, Tehran University of Medical Sciences, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Davoud Shojaezade
Position
PhD, Health education and Health Promotion
Other areas of specialty/work
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8898 9128
Fax
Email
shojae05@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leila Jahangiry
Position
PhD student
Other areas of specialty/work
Street address
Health Education and Health Promotion Departement, Public Health Faculty, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8898 9128
Fax
Email
jahangiry@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Leila Jahangiry
Position
Ph.D student
Other areas of specialty/work
Street address
Health Education Departemen, Public Health Faculty, Tehran University Of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8898 9128
Fax
Email
jahangiry@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...