Objectives: Customizing and implementing Canadian health promotion program (Healthy Start), aligned with preschool bylaw in Iran and assessing the efficacy of this program on anthropometric parameters, quality of life, physical activity and healthy eating among preschoolers.
Design: In a pilot-controlled trial, preschool girls and boys (aged 4-6) attending preschools are enrolled and the intervention is operated during six months. Due to the pilot design, sample size and randomization are not applicable.
Setting and Conduct: Three preschools from three different socioeconomic status will be non-randomly selected for intervention and three preschools (from the same area) as controls and the intervention will be conducted during six months.
Participants: preschool girls and boys (aged 4-6) attending preschools
Intervention: A program containing five components: 1) promoting physical activity in preschoolers, 2) promoting healthy eating, 3) guiding educators for implementation, 4) active involvement of parents and 5) building partnership
Main Outcome Measures: At baseline and after completion of intervention, anthropometric parameters, nutrition status, physical activity level and quality of life in children of both groups will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041927475N1
Registration date:2016-11-12, 1395/08/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-11-12, 1395/08/22
Registrant information
Name
Atieh Mehdizadeh Hakkak
Name of organization / entity
School of Medicine, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 6951
Email address
mehdizadeha921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Chansllor of Mashhad University of Medical Sciences
Expected recruitment start date
2017-10-04, 1396/07/12
Expected recruitment end date
2018-05-06, 1397/02/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Implementing and Pilot Testing of a Customized Intervention to Increase Physical Activity and Healthy Eating among Preschool Children in Iran
Public title
Implementing and Pilot Testing of a Customized Intervention to Increase Physical Activity and Healthy Eating among Preschool Children in Iran
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Aged 4-6 years
Attending preschool
Signed informed consent of parents or guardian
Exclusion criteria:Known cardiovascular, respiratory, endocrine or musculoskeletal problems (after physician inquiry)
Having particular diet such as gluten-free or phenylalanine-free diets
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Intervention group:
A program containing five components: 1) promoting physical activity in preschoolers (customized training material), 2) promting healthy eating (customized training material, healthy snacks and removing unhealthy buffets), 3) guiding educators for implementation, 4) active involvement of parents 5) building partnership
Category
Lifestyle
2
Description
Control group:
Conventional nutrition and physical activity at preschoolers
Conventional Nutrition: There is no snack protocol or nutrition recommendation in preschools. (open snack)
Conventional physical activity: There is no guideline for duration and types of physical activity in preschools.
Conventional physical activity:
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Three preschools non-randomly selected from three different socioeconomic status
Full name of responsible person
Atieh Mehdizadeh Hakkak
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Nematy
Street address
School of Medicine, Azadi Square, Mashhad, Iran
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Atieh Mehdizadeh
Position
PhD Candidate
Other areas of specialty/work
Street address
School of Medicine, Azadi square, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3884 6951
Fax
Email
mehdizadeha921@mums.a.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mehdizadeh
Full name of responsible person
Atieh
Position
PhD Candidate
Other areas of specialty/work
Street address
School of Medicine, Azadi Square, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3884 6951
Fax
Email
mehdizadeha921@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Atieh Mehdizadeh
Position
MD, PhD student
Other areas of specialty/work
Street address
School of Medicine, Azadi square, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3884 6951
Fax
Email
mehdizadeha921@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)