Protocol summary

Summary
Objectives: Determination of the effect of education by mother's monitoring on physical activity of children that suffering of overweight and obesity in first grade to third grade in Behbahan. Design: This field trial is before and after done on the mothers of child 7 to 9 years old, that suffering of overweight in Behbahan. Participants: Using cluster sampling 96 samples were selected for each test and control groups. Inclusion criteria: Mother has child with overweight and obesity, aged 7 to 9 years old and is studying in Behbahan's schools. Mother is educated. Healthy children to be determined from the disease than obesity and did not treatment of obesity.Exclusion criteria: Mother and Child is not possible to continue working with researchers. Setting and conduct: firstly obtained anthropometric data of child , secondly Information collected by questionnaires from mothers of both groups and based on that training program will be designed, thirdly Mothers in the intervention group attended five training sessions and finally done Evaluation of the intervention program with the statistical analysis.Intervention: In this scheme, Training will be designed on the basis of Transtheoretical model. The primary outcome of study will be , Increased mother monitoring on your child's physical activity and Other consequences Increasing physical activity, Reducing inactivity in children, Increased efficacy, Processes of change, The balance of making decision in mothers.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015112425230N1
Registration date: 2016-01-03, 1394/10/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-03, 1394/10/13
Registrant information
Name
Afifeh Abednejad
Name of organization / entity
Yasuj University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 5287 0659
Email address
abednejada@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Yasuj University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study effects of a mother contentered education on physical activity of overweight and obese grade 1-3 students
Public title
Increased monitoring of the mother on child's physical activity suffering from overweight and obesity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Mother has child aged 7 to 9 years; Child is studying in Behbahan's schools; Mother has child that suffering of overweight and obesity; Mother is educated; Also child do not suffering from certain diseases such as Mental retardation; Psychological symptoms; Chronic Diseases like Endocrine disorders (Cushing, Hypothyroidism) Apart from obesity; Child does not use drugs like (Antipsychotic, Anti-depressant, Corticosteroids, Anticonvulsants, Insulin) and also does not Treated for his/her obesity; not considered Physical activity program for children. Exclusion criteria: Mother and Child is not possible to continue working with researchers; Children lost the ability to perform physical activity.
Age
From 7 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 192
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Using cluster sampling

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kohgiloye and Boyer Ahmad University of Medical Science
Street address
Vice chancellor for research University, Shahid Motahari avenue, Yasuj
City
Yasuj
Postal code
Approval date
2015-02-22, 1393/12/03
Ethics committee reference number
YUMS.REC.1394.29

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
mother's monitoring on physical activity of her child
Timepoint
Before of intervention and one month after intervention
Method of measurement
Researcher made questionnaire to measure the stage of change for monitoring of mother

Secondary outcomes

1

Description
Mother's awareness of physical activity
Timepoint
Before of intervention and one month after intervention
Method of measurement
Researcher made questionnaire Mother's awareness of physical activity

2

Description
Processes of change mother
Timepoint
Before of intervention and one month after intervention
Method of measurement
Researcher made questionnaire Processes of change mother

3

Description
Decisional balance mother
Timepoint
Before of intervention and one month after intervention
Method of measurement
Researcher made questionnaire Decisional balance mother

4

Description
Self-efficasy mother
Timepoint
Before of intervention and one month after intervention
Method of measurement
Researcher made questionnaire Mother's Self-efficasy

5

Description
Physical activity of child
Timepoint
Before of intervention and one month after intervention
Method of measurement
Standard questionnaire Physical activity of child

Intervention groups

1

Description
Intervention group: Educational lectures and individual counseling
Category
Behavior

2

Description
Control group: Without intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
office of education Behbahan city
Full name of responsible person
Afifeh Abednejad
Street address
City
Behbahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Yasuj University of Medical Science
Full name of responsible person
Kambiz Karimzadeh Shirazi
Street address
Health Faculty of Yasuj University of Medical Science, Yasuj
City
Yasuj
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 of Yasuj University of Medical Science
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
Yasuj University of Medical Science
Full name of responsible person
Afifeh Abednejad
Position
Master Student of Health Education
Other areas of specialty/work
Street address
Health Faculty of Yasuj University of Medical Science, Yasuj
City
Bebahan
Postal code
Phone
+98 61 5287 1252
Fax
Email
abednejada@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Vice chancellor for research, Yasuj University of Medical Science
Full name of responsible person
Kambiz Karimzadeh Shirazi
Position
Expert of Health Education
Other areas of specialty/work
Street address
Health Faculty of Yasuj University of Medical Science, Yasuj
City
Yasuj
Postal code
Phone
+98 74 3322 3505
Fax
+98 74 3322 6715
Email
karimzadehshirazi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Afifeh Abednejad
Position
Master Student of Health Education
Other areas of specialty/work
Street address
NO 25, Janbazan Alley, Emam Reza Ave, Behbahan
City
Behbahan
Postal code
Phone
+98 61 5287 1252
Fax
Email
abednejada@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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