Protocol summary

Study aim
Determination of the effectiveness of a family-centered educational program
Design
Study Phase: Not true The blind group does not exist in the study. sample size: 60 people Randomization:randomized allocation to Intervention and Control Groups Other design features of the study: First of all, Ilam city centers, city center number 6 was selected because of the high coverage of mothers.Samples were also randomly divided into intervention and control groups
Settings and conduct
The study site is Ilam Urban Comprehensive Health Center 6 Center 6 covers a population of 1,4856, with the highest population among urban centers. The population of the mothers covers 7605 people. Of these 98 mothers with children aged 6 months to 1 year,Samples were randomly divided into intervention and control groups
Participants/Inclusion and exclusion criteria
1- Having a child aged 6 months to 1 year 2. Having a healthy child 3. Having a health record 4. Have at least reading and writing skills Exclusion criteria 1- Being pregnant with mothers 2. The underlying disease of mothers and their children 3. Separation and Divorce of Parents
Intervention groups
Intervention group includes mothers who are eligible for study and receive education plan The control group consisted of mothers who were enrolled and did not receive training
Main outcome variables
The main implications of the application: intention of behavior Time sections of measurement: Prior to intervention and 6 months after intervention How to measure: The questionnaire

General information

Reason for update
Acronym
Tehran Tooth Study
IRCT registration information
IRCT registration number: IRCT20190716044227N1
Registration date: 2019-09-25, 1398/07/03
Registration timing: registered_while_recruiting

Last update: 2019-09-25, 1398/07/03
Update count: 0
Registration date
2019-09-25, 1398/07/03
Registrant information
Name
bahareh kabiry
Name of organization / entity
Tarbiat modares univercity
Country
Iran (Islamic Republic of)
Phone
+98 84 3333 6210
Email address
b.kabiri@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and Evaluation of family - based training programs on the prevention of tooth decay behaviors of 6 months to one - year - old based on intervention Mapping Approach
Public title
Design and evaluation of dental caries prevention training program
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1- Have a child aged 6 months to 1 year 2. Have a healthy child 3. Have a health record 4. Have at least reading and writing skills
Exclusion criteria:
1. Mothers are not pregnant. 2. Mothers do not have underlying illness. 3. Parents do not live apart.
Age
From 20 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random number table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Samples were randomly divided into intervention and control groups

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
Jalal Street-under Paul Geisha-Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2019-04-30, 1398/02/10
Ethics committee reference number
IR.ModARES.REC.1398.021

Health conditions studied

1

Description of health condition studied
Oral Health
ICD-10 code
ko3.2
ICD-10 code description
بهداشت دهان و دندان

Primary outcomes

1

Description
Awareness - attitude - perceived intensity - perceived benefits -perceived barriers- guidance for action - self - efficacy - intention of behavior - mental norms - social norms
Timepoint
Before educational intervention and 6 months after educational intervention
Method of measurement
Researcher-made questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Combined training including PowerPoint use, lectures, replica use and hands-on demonstration for 4 training sessions
Category
Behavior

2

Description
Control group: The control group received no training
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
مرکز جامع سلامت شهری شماره شش شهرستان ایلام
Full name of responsible person
بهاره کبیری
Street address
میدان شهید کشوری- مرکز جامع سلامت شهری شماره شش
City
ایلام
Province
Ilam
Postal code
6931943445
Phone
+98 84 3333 4270
Email
kabirybahar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Assistance Research
Full name of responsible person
yacob fatolahi
Street address
Jalal Street-under Paul Geisha-Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
Email
fatolahi@modares.ac.ir
Grant name
Is not used
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Assistance Research
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
Tarbiat Modares University
Full name of responsible person
Alireza Heydarnia
Position
Professor, Department of Health Education, Faculty of Medicine, Tarbiat Modarres University, Tehran,
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal Street-under Paul Geisha-Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3817
Email
hidarnia@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
bahareh kabiry
Position
PhD student in health education and health promotion Tarbiat Modarres
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Jalal Street-under Paul Geisha-Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3817
Email
kabirybahar@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
bahareh kabiry
Position
PhD student in health education and health promotion Tarbiat Modarres University
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Jalal Street-under Paul Geisha-Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3817
Email
hidarnia@modares.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
After the study is completed
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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