Protocol summary

Summary
(1) Objectives: investigating the impact of educational intervention on promotion of preventive behaviors of metabolic syndrome in premenopausal women in Gachsaran. (2) Design: This study has an intervention type. The sample consists of 130 people which is divided into two groups of 65 people.(3) Setting and conduct: The data is accumulated in field research method and accumulating tools included the health belief pattern questionnaire which is created by researcher, 24-hour dietary recall questionnaire for 3 days and the check list of daily records of duration and intensity of physical activity. Type of intervention is in 3 stages. In first stage both groups are provided with questionnaires and check list and in second stage we are holding educational 4 sessions in one week interval for subject group and in third stage after 2 months the questionnaires and check list would be completed for both group again. (4) Participants including major eligibility criteria, Inclusion criteria: over 40 years women, no menopause, with no history of disease associated with menopause, without consumption of any related drugs to this disease, willingness to corporate, complete contribution in educational sessions. Major Exclusion criteria: lack of input criteria. (5) Intervention: training Intervention. (6) The main outcome measures: knowledge and believes of premenopausal women who their age is above 40 years about preventive behaviors of metabolic syndrome, dietary patterns and physical activities of preventive of metabolic syndrome .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016011924987N1
Registration date: 2016-01-19, 1394/10/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-19, 1394/10/29
Registrant information
Name
Shirin Davodi
Name of organization / entity
Yasouj univercity of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 6850
Email address
davoodishirin@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Yasouj University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigating the impact of educational intervention on promotion of preventive behaviors of metabolic syndrome in premenopausal women .
Public title
The impact of educational intervention on preventive behaviors of metabolic syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: over 40 years women؛ no menopause؛ with no history of disease associated with menopause؛ without consumption of any related drugs to this disease؛ willingness to corporate؛ complete contribution in educational sessions. Exclusion criteria: lack of input criteria.
Age
From 40 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 130
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasouj University of Medical Sciences
Street address
Next to the Damideh health center, Yasouj
City
Yasouj
Postal code
Approval date
2015-07-23, 1394/05/01
Ethics committee reference number
YUMS.REC.1394.84

Health conditions studied

1

Description of health condition studied
-
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Believes of premenopausal women who their age is above 40 years about preventive behaviors of metabolic syndrome
Timepoint
Before the intervention and 2 months after intervention
Method of measurement
Researcher made questionnaire the health belief pattern

2

Description
knowledge of premenopausal women who their age is above 40 years about preventive behaviors of metabolic syndrome
Timepoint
Before the intervention and 2 months after intervention
Method of measurement
Researcher made questionnaire to assess knowledge about preventive behaviors of metabolic syndrome

3

Description
Dietary patterns of preventive of metabolic syndrome
Timepoint
Before the intervention and 2 months after intervention
Method of measurement
24-hour dietary recall questionnaire

4

Description
Physical activities of preventive of metabolic syndrome
Timepoint
Before the intervention and 2 months after intervention
Method of measurement
The check list of daily records of duration and intensity of physical activity

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Control group: Complete of researcher made questionnaire the health belief pattern, researcher made questionnaire to assess knowledge about preventive behaviors of metabolic syndrome, 24-hour dietary recall questionnaire and check list of daily records of duration and intensity of physical activity.
Category
Prevention

2

Description
Intervention group: Complete of researcher made questionnaire the health belief pattern, researcher made questionnaire to assess knowledge about preventive behaviors of metabolic syndrome, 24-hour dietary recall questionnaire and check list of daily records of duration and intensity of physical activity and Nutrition and physical activity education about of preventive behaviors of metabolic syndrome in 4 sessions of 2 hours.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center Shahid Husseini
Full name of responsible person
Shirin Davodi
Street address
Between lane 5 and 6 North, Karkonan street, Gachsaran K
City
Gachsaran

2

Recruitment center
Name of recruitment center
Health Center Shahid Motahari
Full name of responsible person
Shirin Davodi
Street address
Boulevard Bessat, Pansad Dastgah Street, Gachsaran
City
Gachsaran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research, Yasouj University of Medical Sciences
Full name of responsible person
Kambiz Karimzadeh Shirazi
Street address
Next to the Damydeh health center, Yasouj
City
Yasouj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Yasouj 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
Yasouj Univercity of Medical Sciences
Full name of responsible person
Shirin Davodi
Position
Master degree student of health education
Other areas of specialty/work
Street address
Next to the Damydeh health center, Yasouj
City
Yasouj
Postal code
6571933684
Phone
+98 917 146 9070
Fax
Email
davoodishirin@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj Univercity of Medical Sciences
Full name of responsible person
Kambiz Karimzadeh Shirazi
Position
PhD Candidate in Health Education
Other areas of specialty/work
Street address
Next to the Damideh health center,Ccollege of public health, Yasouj
City
Yasouj
Postal code
7591741417
Phone
+98 74 3322 6850
Fax
Email
karimzadehshirazi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasouj Univercity of Medical Sciences
Full name of responsible person
Shirin Davodi
Position
Master degree student of health education
Other areas of specialty/work
Street address
Next to the Damideh health center, Yasouj
City
Yasouj
Postal code
6571933684
Phone
Fax
Email
davoodishirin@yahoo.com
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
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