Comparison of two training methods including face to face and a short message for modification the nutrition, physical activity and cholesterol levels in women with high blood cholesterol
Comparison of two training methods including face to face and a short message for modification the nutrition, physical activity and cholesterol levels in women with high blood cholesterol
Design
This study is a non-blinded clinical trial. The study population will be included all women with high blood cholesterol who will refer to comprehensive health care center of Kermanshah city.165 eligible patients will be selected conveniently and randomly will be assigned to two intervention groups and one control group.
Settings and conduct
This study that will be conducted in a comprehensive health care center of Kermanshah city, is non-blinded one. At the beginning of the study, nutritional status and physical activity will be measured using a questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cholesterol levels above 200; Having a mobile phone and the ability to read text messages
Exclusion criteria: People with cardiovascular disease, diabetes, and high blood pressure; Taking statin medications; already get training before the start of the study
Intervention groups
The first intervention group will receive the modification of nutrition and physical activity (educational content based on educational packages of the Ministry of Health) via texting as 2 weekly text messages for 12 weeks. The second intervention group will receive the modification of nutrition and physical activity (educational content based on educational packages of the Ministry of Health) face-to-face, monthly for a period of three months. The control group will not receive any intervention.
Main outcome variables
Cholesterol level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N114
Registration date:2019-02-27, 1397/12/08
Registration timing:prospective
Last update:2019-02-27, 1397/12/08
Update count:0
Registration date
2019-02-27, 1397/12/08
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-06, 1397/12/15
Expected recruitment end date
2019-06-15, 1398/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two training methods including face to face and a short message for modification the nutrition, physical activity and cholesterol levels in women with high blood cholesterol
Public title
Comparison of two training methods including face to face and a short message for modification the nutrition, physical activity and cholesterol levels in women with high blood cholesterol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cholesterol levels above 200
Having a mobile phone and the ability to read text messages
Minimum age 30 years
Exclusion criteria:
People with cardiovascular disease, diabetes and high blood pressure
Taking Statin medications
already get training before the start of the study
Age
From 30 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
165
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt
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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-11-14, 1397/08/23
Ethics committee reference number
ir.kums.rec.1397.576
Health conditions studied
1
Description of health condition studied
Hypercholesterolemia
ICD-10 code
E78.0
ICD-10 code description
Pure hypercholesterolemia
Primary outcomes
1
Description
Cholesterol level
Timepoint
The beginning and end of the study
Method of measurement
Using blood tests
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive the modification of nutrition and physical activity (educational content based on educational packages of the Ministry of Health) via texting as 2 weekly text messages for 12 weeks
Category
Treatment - Other
2
Description
The second intervention group will receive the modification of nutrition and physical activity (educational content based on educational packages of the Ministry of Health) face-to-face monthly for a period of three months
Category
Treatment - Other
3
Description
The control group will not receive any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Center
Full name of responsible person
Neda Yavari
Street address
Ellahyah, Taleghani Street
City
Kermanshah
Province
Kermanshah
Postal code
6719936646
Phone
+98 83 3835 5349
Email
n414yavari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Neda Yavari
Position
Masters student in health education and health promotion
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
School of Health, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 988338264165
Email
n414yavari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Behrooz Hamzeh
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health promotion
Street address
School of Health, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 99838264165
Email
behrooz.hamzeh@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Neda Yavari
Position
Masters student in health education and health promotion
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
School of Health, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3826 4165
Email
n414yavari@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail