Determining the effect of home-based nutritional intervention program on anthropometric indices in obese and overweight preschool children of Urmia city
Design
A 6-month phase III cluster randomized parallel clinical trial on 260 overweight or obese preschool children
Settings and conduct
The present study is a community-based cluster randomized controlled trial in Urmia city, Iran. This study will be conducted among overweight and obese preschoolers. After receiving the code of ethics from Urmia University of Medical Sciences, sampling will be done from the health centers of Urmia city as clusters. The primary outcome of this study will be to find the effect of a 6-month home-based nutritional intervention program on improving the anthropometric indices of obese or overweight children and the constructs of the health belief model of mothers with obese and overweight children.
Participants/Inclusion and exclusion criteria
Inclusion criteria: overweight (body mass index z-score for age between +2 and +3) and obese (body mass index z-score for age above +3) preschoolers (2 to 5 years old)
Exclusion criteria: preschool children with a known history of systemic diseases such as heart problems, kidney problems, cancer, etc., or parents who are absent in more than 20% of home visits
Intervention groups
Intervention group training: 1- Basic nutritional training based on the guidelines of the Ministry of Health 2- A nutritional pamphlet prepared for this study 3- Providing several low-calorie nutritious food recipes to mothers and 4- Behavioral training based on the health belief model to implement diet changes dietary for 6 months. This intervention will be provided in addition to regular services in health centers.
Control group training: Routine training of health centers for 6 months
Main outcome variables
Body mass index, subcutaneous fat, waist circumference, health belief model structure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090124001580N8
Registration date:2023-11-08, 1402/08/17
Registration timing:prospective
Last update:2023-11-08, 1402/08/17
Update count:0
Registration date
2023-11-08, 1402/08/17
Registrant information
Name
Shahsanam Gheibi
Name of organization / entity
Maternal and Childhood Obesity research Center, Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3222 6969
Email address
drgheibi@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of a home-based nutritional intervention program on anthropometric indices of preschool children with overweight and obesity
Public title
Effectiveness of a home-based nutritional intervention program on childhood obesity
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight children (body mass index z-score for ages between +2 and +3) and obese children (body mass index z-score for ages above +3)
Exclusion criteria:
Preschool children with a known history of systemic diseases such as heart problems, kidney problems, cancer
Children or parents who are absent in more than 20% of home visits
Taking medicine or nutritional supplements affecting weight in children
Age
From 2 years old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
260
Randomization (investigator's opinion)
Randomized
Randomization description
This study will follow cluster randomization to assign subjects to intervention and control groups. Individuals in the same clusters will receive the same intervention. There are 63 health centers and 5 urban areas in Urmia city. The randomization strata will be based on urban areas so that subjects will be the same in terms of socioeconomic level between the two groups. Considering the average number of children registered in health centers and calculating the sample size, this study will require the selection of 10 health centers. In fact, 2 health centers from each urban area will be included in the study (each group = 5 clusters). These 2 centers will be randomly selected by lottery among all health centers in that area. Then 2 clusters selected from each strata will be divided into two intervention or control groups by simple randomization method and using coins.
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 Urmia University of Medical Sciences
Street address
Orjhans Street, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2023-11-07, 1402/08/16
Ethics committee reference number
IR.UMSU.REC.1402.220
Health conditions studied
1
Description of health condition studied
Obesity and overweight
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Body mass index
Timepoint
Before the start of the intervention, 3 and 6 months after the start of the intervention
Method of measurement
Formula
2
Description
Constructs of health belief model
Timepoint
Before the start of the intervention, 3 and 6 months after the start of the intervention
Method of measurement
Questionnaire
3
Description
Percentage of subcutaneous fat
Timepoint
Before the start of the intervention, 3 and 6 months after the start of the intervention
Method of measurement
Caliper device
4
Description
Waist circumference
Timepoint
Before the start of the intervention, 3 and 6 months after the start of the intervention
Method of measurement
Tape measure
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The trainings include 1- Basic nutritional training based on the guidelines of the Ministry of Health, 2- A nutritional pamphlet prepared for this study, 3- Providing several low-calorie nutritious food recipes to mothers, and 4- Behavioral training based on the health belief model to implement dietary changes for 6 months
Category
Lifestyle
2
Description
Control group: Routine training of health centers for 6 months
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia city health centers
Full name of responsible person
Amir Hossein Faghfouri
Street address
Orjhans Street, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7154
Email
amir.nut89@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Shahsanam Gheibi
Street address
Orjhans Street, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3223 4897
Email
gheibi1345sh@gmail.com
Grant name
Grant code / Reference number
12341
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
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
Oroumia University of Medical Sciences
Full name of responsible person
Shahsanam Gheibi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Orjhans Street, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3223 4897
Email
gheibi1345sh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Amir Hossein Faghfouri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Orjhans Street, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3223 4897
Email
amir.nut89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Amir Hossein Faghfouri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Orjhans Street, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3223 4897
Email
amir.nut89@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Information about the main outcomes can be shared at the end of the study
When the data will become available and for how long
The access period will be 6 months after publication
To whom data/document is available
The data from this study will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Six month after the publication of the articles obtained from the data of this project, the study data can be made available to the researchers upon request from the person in charge of the project and his/her approval
From where data/document is obtainable
Applicants can contact the corresponding author through the email or postal address below to receive the desired data. Postal address: Urmia University of Medical Sciences, Orjhans Street, Resalat Blvd. Contact number: 00984432234897. Email: gheibi1345sh@gmail.com
What processes are involved for a request to access data/document
Applicants will be able to access the data from the study by sending an email to the responsible author, at most after a week.