The aim of the present study is to assess the effects of an educational program based on Social- Cognition Theory (SCT) to increase consumption of healthy snacks in 1-5 year children. In this study 126 eligible mothers from 6 health centers (3 health center for intervention group and 3 health center for control group) in Hamedan will be randomly allocated to intervention and control groups. The participants with the following criteria will be included in the study: having 1-5 year old child; having an active medical recode in the health center; voluntarily participate in the study. The participants with each one of the following criteria will be excluded from the study: absence from educational session more than twice, migration. For mothers of intervention group 4 education sessions based on proper strategies to change SCT constructs will be hold during two weeks. Each session lasted about 45 minutes. A reminder of motivational message will be given to intervention group 30 days after the intervention. Main outcome measures: demographic variables, SCT constructs, and child's frequency of healthy and unhealthy snacks consumption. These variables will be measured at baseline, 10 days after intervention, and 2 months after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013062912456N2
Registration date:2013-07-11, 1392/04/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-07-11, 1392/04/20
Registrant information
Name
Akram Karimi-Shahanjarini
Name of organization / entity
Hamedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0583
Email address
karimi.a@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-08-27, 1392/06/05
Expected recruitment end date
2013-12-06, 1392/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of educational programs based on social cognition theory on increase healthy snacks consumption among children 1-5 years old
Public title
Educational intervention and healthy snacks
Purpose
Prevention
Inclusion/Exclusion criteria
The participants with the following criteria will be included in the study: having 1-5 year old child; having an active medical recode in the health center; voluntarily participate in the study. The participants with each one of the following criteria will be excluded from the study: absence from educational session more than twice, migration.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
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
Hamadan University of Medical Science
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave Hamadan
City
Hamadan
Postal code
Approval date
2013-06-12, 1392/03/22
Ethics committee reference number
d/p/16/35/9/760
Health conditions studied
1
Description of health condition studied
Healthy snacks consumption
ICD-10 code
Z72.4
ICD-10 code description
Inappropriate diet and eating habits
Primary outcomes
1
Description
Healthy snacks frequency
Timepoint
baseline, 10 days after intervention, 2 months after intervention
Method of measurement
questionnaire
2
Description
Outcome expectancy
Timepoint
Ten days after intervention, two months after intervention
Method of measurement
Questionnaire
3
Description
Knowledge
Timepoint
Ten days after intervention, two months after intervention
Method of measurement
Questionnaire
4
Description
self-efficacy
Timepoint
Ten days after intervention, two months after intervention
Method of measurement
Questionnaire
5
Description
availability
Timepoint
Ten days after intervention, two months after intervention
Method of measurement
Questionnaire
6
Description
observational learning
Timepoint
Ten days after intervention, two months after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
unhealthy snacks consumption
Timepoint
baseline, 10 days after intervention, 3 months after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Four 45- minute education sessions during two weeks based on proper strategies to change in SCT constructs including:
- Persuasive messages and giving information through lecture, group discussion, and booklet,
-Self monitoring, and goal setting through booklet home assignments after each and booklet
- Persuasive messages through Telephone / text-message reminders 30 days after the last session of intervention
Category
Prevention
2
Description
Control group: Booklet after the second post test
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
No. 1 Sameei health center
Full name of responsible person
Street address
City
Hamedan
2
Recruitment center
Name of recruitment center
No. 9 Sameei health center
Full name of responsible person
Hamedan
Street address
Hamedan
City
Hamedan
3
Recruitment center
Name of recruitment center
Farhangian health center
Full name of responsible person
Street address
City
Hamedan
4
Recruitment center
Name of recruitment center
Etemadieh health center
Full name of responsible person
Street address
City
Hamedan
5
Recruitment center
Name of recruitment center
Shahid Madani health center
Full name of responsible person
Street address
City
Hamedan
6
Recruitment center
Name of recruitment center
No. 10 Sameei health center
Full name of responsible person
Street address
Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Ahmad Tavilani
Street address
Hamedan University of Medical Sciences
City
Hamedan
Grant name
از محل يك درصد بودجه طرحهاي تحقيقاتي دانشگاه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic-chancellor of Research and 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
Hamedan University of Medical Sciences
Full name of responsible person
Akram Karim
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 1838 0509
Fax
Email
karimi.a@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Akram Karimi
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 1838 0583
Fax
Email
karimi.a@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Akram Karimi
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 1838 0717
Fax
Email
karimi.a@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)