Protocol summary

Summary
General Purpose: design, implementation and evaluation of programs to increase physical activity for mothers who have 1-5 years old children in health centers in Isfahan. Design Study: randomized, single blind and multicenter. Target Population: mothers who have 1-5 years old children in health centers in Isfahan. Inclusion Criteria: the mothers under the care who have at least one child 1 to 5 years old; who are not pregnant; have no limitation for doing exercise; are residents of the same area during the performance of the plan. Exclusion Criteria: finding limits for physical activity (such as pregnancy or illness) at the time of plan implementation; in compliance to continue participation in the plan; lack of participation in classes regularly. Sample Size: 166 Intervention: a 4-week intervention program and follow up 1 and 3 months after the start of the project, intervention including a group training session in health care center settings and providing two training booklets for participants. Primary Outcome: the change of physical activity level

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015050722145N1
Registration date: 2015-06-03, 1394/03/13
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-06-03, 1394/03/13
Registrant information
Name
ZahraDana Siadat
Name of organization / entity
Isfahnan Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 8110
Email address
z_dsiadat@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-06-05, 1394/03/15
Expected recruitment end date
2015-08-06, 1394/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation and evaluation of programs to increase physical activity for mothers who have 1-5 years old children
Public title
Physicai activity of the mothers who have 1-5 years old children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: the mothers under the care who have at least one child 1 to 5 years old; who are not pregnant; have no limitation for doing exercise; are residents of the same area during the performance of the plan. Exclusion Criteria: finding limits for physical activity (such as pregnancy or illness) at the time of plan implementation; incompliance to continue participation in the plan; lack of participation in classes regularly.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 166
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University Of Medical Sciences
Street address
St Hezar jerib, Isfahan University of Medical Sciences and Health Services, Isfahan, Iran
City
Isfahan
Postal code
81746-73461
Approval date
2014-05-28, 1393/03/07
Ethics committee reference number
393416

Health conditions studied

1

Description of health condition studied
healthy
ICD-10 code
XXI
ICD-10 code description
Factors influencing health status and contact with health services

Primary outcomes

1

Description
physical activity
Timepoint
Before intervention and 1 and 3 months after the start project
Method of measurement
International physical activity questionnaire (MET-minutes/week)

Secondary outcomes

1

Description
Waist circumstance
Timepoint
Before and 1 and 3 months after the start project
Method of measurement
By tape meter(cm)

2

Description
Hip circumference
Timepoint
Before and 1 and 3 months after the start project
Method of measurement
By tape meter(cm)

3

Description
Well being
Timepoint
Before and 1 and 3 months after the start project
Method of measurement
General health questionnaire-12

4

Description
Blood pressure
Timepoint
Before and 1 and 3 months after the start project
Method of measurement
Standard mercury sphygmomanometer(mm/hg)

5

Description
Body mass index
Timepoint
Before and 1 and 3 months after the start project
Method of measurement
Weight (using a calibrated scale) and height (by tape meter) as kg/m2

Intervention groups

1

Description
Intervention Group: a one-hour group training session, education of goal setting strategy in a one-hour training session, assessment goal setting forms at four weeks
Category
Lifestyle

2

Description
Control Group: a one-hour group training session
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Azadegan health center
Full name of responsible person
Street address
City
Isfahan

2

Recruitment center
Name of recruitment center
Imam Ali health center
Full name of responsible person
Street address
City
Isfahan

3

Recruitment center
Name of recruitment center
4th Imam Ali health center
Full name of responsible person
Street address
City
Isfahan

4

Recruitment center
Name of recruitment center
Amirhamzeh health center
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Isfahan University of Medical Sciences
Street address
Isfahna Univercity of Medical Sciences, Hezar Jarib, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
jiryaee nasrin
Position
Resident of Community Medicine
Other areas of specialty/work
Street address
Isfahna Univercity of Medical Sciences, Hezar Jarib, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3650 2332
Fax
Email
n_jiryaee@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahna Univercity of Medical Sciences
Full name of responsible person
Jiryaee nasrin
Position
Resident of Community Medicine
Other areas of specialty/work
Street address
Isfahna Univercity of Medical Sciences, Hezar Jarib, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3650 2332
Fax
Email
n_jiryaee@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahna Univercity of Medical Sciences
Full name of responsible person
Jiryaee nasrin
Position
Resident of Community Medicine
Other areas of specialty/work
Street address
Isfahna Univercity of Medical Sciences, Hezar Jarib, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3650 2332
Fax
Email
n_jiryaee@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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