Objectives: To assess the effect of feeding behavior education to mothers versus no education on eating habits among toddler children.
Design: a before-after clinical trial.
Setting and conduct: The eligible mothers who will refer to kindergartens of Hamadan City during the study period will be enrolled into the trial.
Inclusion criteria: (a) mothers having a child of 12 to 36 month old; (b) first child; (c) resident of Hamadan City; (d) mother being responsible for child diet; (e) being at least literate; (f) not being health worker.
Exclusion criteria: (a) irregular participation in the educational sessions; (b) the being affected with acute or systemic diseases; (c) mother or child being having mental disorder; (d) migration of the mother and child form the selected kindergarten.
Intervention group: Two educational sessions one hour each in two consecutive days through speech, question and answer, and group discussion.
Control group: No educational course.
Primary outcome: Assessing the eating habits among toddler children before and one month after educational intervention using Lewinshon Feeding Problem Questionnaire.
Secondary outcome: Nothing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506079014N66
Registration date:2015-07-04, 1394/04/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-04, 1394/04/13
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of feeding behavior education to mothers versus no education on eating habits among toddler children: a before-after clinical trial
Public title
The effect of feeding behavior education to mothers versus no education on eating habits among toddler children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: (a) mothers having a child of 12 to 36 month old; (b) first child; (c) resident of Hamadan City; (d) mother being responsible for child diet; (e) being at least literate; (f) not being health worker.
Exclusion criteria: (a) irregular participation in the educational sessions; (b) the being affected with acute or systemic diseases; (c) mother or child being having mental disorder; (d) migration of the mother and child form the selected kindergarten.
Age
From 1 year old to 3 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: First, Hamadan City is divided into north, south, west, and east regions. Then, from 130 active kindergartens, based on the geographical distribution, 4 to 6 kindergartens are selected. Then, the eligible mothers are randomly assigned to the intervention and control groups using random numbers table.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
D/P/16/35/9/4868
Health conditions studied
1
Description of health condition studied
Eating habits
ICD-10 code
F50
ICD-10 code description
Eating disorders
Primary outcomes
1
Description
Assessing the eating habits among toddler children
Timepoint
before and one month after educational intervention
Method of measurement
using Lewinshon Feeding Problem Questionnaire
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Two educational sessions one hour each in two consecutive days through speech, question and answer, and group discussion.
Category
Prevention
2
Description
No educational course.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Nursing and Midwifery School
Full name of responsible person
Shahnaz Salawati Ghasemi
Street address
Nursing and Midwifery School, Shahid Fajmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Nursing and Midwifery School
Full name of responsible person
Shahnaz Salawati Ghasemi
Position
Nursing Student
Other areas of specialty/work
Street address
Nursing and Midwifery School, Shahid Fajmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0535
Fax
Email
shahnaz.salawati68@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery School
Full name of responsible person
Dr Fatemeh Cheraghi
Position
Infant Nursing Specialist
Other areas of specialty/work
Street address
Nursing and Midwifery School, Shahid Fajmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0535
Fax
Email
f_cheraghi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)