Designing and evaluation of an educational program to the promotion of weight management among preschoolers in Tehran based on PRECEDE-PROCEED model
Design
This study is a two-arm parallel randomized controlled trial with one blinded and 80 samples.
Settings and conduct
a quasi-experimental study in preschools of Tehran, one blinded in participants.
Participants/Inclusion and exclusion criteria
Preschools' mothers residing in Tehran,
Illness child and taking drugs,
Unwilling to participate in the study.
Intervention groups
To perform a designed educational program in the intervention group to promote weight management among children,
Performing the usual program of preschool in the control group.
Main outcome variables
Weight changes among children; children's quality of life; nutrition and physical activity behaviors.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190413043257N1
Registration date:2019-04-23, 1398/02/03
Registration timing:prospective
Last update:2019-04-23, 1398/02/03
Update count:0
Registration date
2019-04-23, 1398/02/03
Registrant information
Name
Najmeh Hamzavi Zarghani
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 71 3262 2321
Email address
n_hamzavizarghani@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and evaluation of an educational program to promotion of weight management among 3-5 years children in Tehran based on PRECEDE PROCEED model
Public title
education for promotion weight management among children based on PRECEDE PROCEED
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
preschools' mothers residing Tehran
Exclusion criteria:
illness child and taking drugs
unwilling to participate in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random numbers table, the participants will be assigned in the control and intervention groups. This table contains a lot of numbers without a specific pattern. Initially, the researcher predetermined the direction of reading numbers (for example, left, right, up, or down). the second is to consider numbers for different groups, for example, even numbers for the intervention group and the odd numbers for the control group. Then the researcher points to one of the numbers and moves in one of the predicted directions and records the numbers and assigns them to different groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants won't be informed that they are in the intervention group or in the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
Tarbiat Modares University, Nasr, Jalal al ahmad street, Tehran.
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2018-06-27, 1397/04/06
Ethics committee reference number
IR.MODARES.REC.1397.034
Health conditions studied
1
Description of health condition studied
promotion of weight management
ICD-10 code
F90-F98
ICD-10 code description
Behavioural and emotional disorders with onset usually occurring in childhood and adolescence.
Primary outcomes
1
Description
weight changes
Timepoint
before intervention, Immediately and three months after intervention
Method of measurement
Measuring the weight of children by digital scales
Secondary outcomes
1
Description
Quality of life scores
Timepoint
Measurement of quality of life before intervention as well as immediately and 3 months after intervention.
Method of measurement
Using children's Quality of life questionnaire
2
Description
score of nutritional behaviors of children.
Timepoint
Measurement of nutritional behaviors of children before intervention as well as immediately and 3 months after intervention.
Method of measurement
Using nutritional behaviors questionnaire of children.
3
Description
score of physical activity behavior of children.
Timepoint
Measurement of physical activity behaviors of children before intervention as well as immediately and 3 months after intervention.
Method of measurement
Using physical activity behavior questionnaire of children.
Intervention groups
1
Description
Intervention group: Tehranian preschoolers' mothers in the intervention group will be received a designed educational program to manage the weight of children. This educational program will be based on the results from the qualitative phase of the study and PRECEDE / PROCEED model. This model is one of the most comprehensive and widely used of models in health education to assess social, epidemiological, behavioral and educational factors regarding behavioral modification. Training includes educational sessions in the form of questions and answers about the history of weight disorders in preschoolers and its complications in childhood and adolescence; as well as priority behaviors such as nutrition, physical activity. Appropriate training materials will be used to train them.
Category
Behavior
2
Description
Control group: Tehranian preschoolers' mothers in the control group will be received a usual program of preschool.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Fazlollah Ghofranipour
Street address
Tarbiat Modarres University, Nasr, Jalal Al Ahmad, Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3869
Email
ghofranf@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Dr. Ya'qub Fathollahi
Street address
Tarbiat Modarres University, Nasr, Jalal Al Ahmad, Tehran
City
Tehran
Province
Tehran
Postal code
141173116
Phone
+98 21 8288 3869
Email
fatolahi@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Medical Sciences, Tarbiat Modares University
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
Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Fazlollah Ghofranipour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tarbiat Modarres University, Nasr, Jehran-Jalal Al Ahmad, Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3869
Email
ghofranf@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Fazlollah Ghofranipour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tarbiat Modarres University, Nasr, Jalal Al Ahmad,Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3869
Email
ghofranf@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Najmeh Hamzavi Zarghani
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
1502, Shahid Haj Zamani Avenue, Imam Khomeini Street,
City
Zarghan
Province
Fars
Postal code
7341815153
Phone
+98 71 3262 2321
Email
n_hamzavizarghani@modares.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic characteristics are confidential, but information on the consequences of weight, quality of life, and behavior changes are shared.
When the data will become available and for how long
A week after receiving a request by email, write to the main investigator.
To whom data/document is available
The researchers in scientific institutions and university of non-communicable disease prevention unit in the Ministry of Health.
Under which criteria data/document could be used
Health departments of medical sciences universities
From where data/document is obtainable
Contact Dr. Fazlollah Ghobranpour by email address GHOFRANF@modares.ac.ir
What processes are involved for a request to access data/document
A week after receiving a request by email to the main investigator.