Protocol summary

Summary
The purpose of this study is evaluation the effectiveness of educational interventions on feeding behavior of mothers of children with phenylketonuria. Inclusion criteria are residency in Tehran؛ having children with phenylketonuria in age from 6 months to 8 years؛ having at least literate؛ have the desire and ability to participate in training sessions. Exclusion criteria are participation in other sessions (with feeding children with phenylketonuria (PKU)) too؛ absence of in one or two sessions؛ unwilling to continue work with the researcher .This study is a quasi-experimental intervention study. The study population consisted of mothers of children with phenylketonuria (PKU) who referred to Iran is center of phenylketonuria and they will be allocated to intervention and control group using randomized sampling by randomization table. Intervention is education with lecture, Ask and answering, group discussion method. Content development and design will be addressed in the context of behavioral intention model.Control group wont participate in educational sessions. data will be collected using self reported questionnaire before and one month after education. Primary outcome of this is study mothers nutritional behavior

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013020612382N1
Registration date: 2013-08-29, 1392/06/07
Registration timing: na

Last update:
Update count: 0
Registration date
2013-08-29, 1392/06/07
Registrant information
Name
Zahra Rahnavard
Name of organization / entity
Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4206
Email address
zrahnavard@sina.tums.ac.ir
Recruitment status
Not enough for processing
Funding source
Tehran University of Medical Sciences, Nursing school
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of education based on behavioral intention model on the feeding behaviors of mothers of children with Phenylketonuria
Public title
Investigating the effect of education based on behavioral intention model on the feeding behaviors of mothers of children with Phenylketonuria
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Residency in Tehran؛ Having children with phenylketonuria in age from 6 months to 8 years؛ Having at least literate؛ have the desire and ability to participate in training sessions Exclusion criteria: Participation in the other sessions (with feeding children with phenylketonuria (PKU)) too؛ Absence of in one or two sessions؛ Unwilling to continue work with the researcher
Age
From 1 year old to 4 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Nursing faculty, Nosrat St, Tohid Sq, Tehran
City
Tehran
Postal code
Approval date
2013-01-02, 1391/10/13
Ethics committee reference number
91/د/130/2528

Health conditions studied

1

Description of health condition studied
Phenylketonuria
ICD-10 code
E70
ICD-10 code description
Classical phenylketonuria

Primary outcomes

1

Description
Mothers Nutritional Behavior
Timepoint
Before After
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Education with lecture, ask and answering , group discussion method. Content development and design will be addressed in the context of behavioral intention model
Category
Other

2

Description
Control group: No intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran Phenylketonuria center
Full name of responsible person
Zahra Rahnavard
Street address
Nursing School, East Nosrat St, Tohid Sq, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences, Nursing school
Full name of responsible person
Dr. Ziba Taghizadeh
Street address
Nursing school, East Nosrat st, Tohid sq, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences, Nursing school
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences, Nursing School
Full name of responsible person
Zahra Rahnavard
Position
PHD
Other areas of specialty/work
Street address
Nursing School, East Nosrat St, Tohid Sq, Tehran
City
Tehran
Postal code
Phone
+98 21 6105 4206
Fax
Email
zahra.rahnavard@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Rahnavard
Position
Associate Professor
Other areas of specialty/work
Street address
Nursing School, East Nosrat St, Tohid Sq, Tehran
City
Tehran
Postal code
Phone
+98 21 6694 1669
Fax
Email
zahra.rahnavard@gmail.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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