Determining and comparing the average of anthropometric indices including height, weight, waist circumference, BMI and BMIz (standardized BMI values) between the group using the mobile application and control groups.
Determining and comparing the mean of physical activity between the group using the mobile application and control groups.
Determining and comparing eating behavior (average weekly consumption of breakfast, fried foods, juices, fast foods, fruits and vegetables, milk and dairy products) between the group using the mobile application and controls group.
Design
Parallel randomized clinical trial with control groups will be performed on 72 overweight and obese adolescents.
Randomization will be done using a table of random numbers.
Settings and conduct
Overweight and obese adolescents randomly selected from schools in Isfahan will be divided into three groups
The intervention group will receive a mobile app that contains customized diet plans, physical activity, and changes in eating behaviors.
The control group receives information similar to the intervention group through printed papers and brochures.
The third group (control) will not receive any information
Participants/Inclusion and exclusion criteria
Age between 9 to 14 years old with overweight or obesity (BMI above 85th percentile)
Having a smart phone
Interested in losing weight
Intervention groups
The intervention group will receive a variety of information on daily diet, physical activity and proper eating behaviors through the mobile app, the control group will receive the same information through paper and brochures, and the Third control group will receive no information.
Main outcome variables
Weight Loss
Increased physical activity
Creating positive nutritional behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120913010826N32
Registration date:2021-03-23, 1400/01/03
Registration timing:retrospective
Last update:2021-03-23, 1400/01/03
Update count:0
Registration date
2021-03-23, 1400/01/03
Registrant information
Name
Azadeh Nadjarzadeh
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 202 2817
Email address
azadnajarzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-13, 1399/11/25
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of nutrition education through mobile application on nutritional behaviors and anthropometric parameters in overweight and obese adolescents
Public title
Effect of nutrition education through mobile application on nutritional behaviors and anthropometric parameters in overweight and obese adolescents
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents 9 to 14 years old with overweight or obesity (BMI above 85th percentile)
Having a smart phone
Interested in losing weight
Exclusion criteria:
Diseases such as diabetes, high blood pressure and ....
Movement disorders
Age
From 9 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done using cluster randomization method. At first, the list of all schools in the 6 districts of Isfahan is prepared and each school is assigned a specific code. A girls 'school and a boys' school are then randomly selected from each district (a total of twelve schools from six districts are randomly selected).
All schools have a list of overweight and obese students. Six eligible students are randomly selected from each school (a total of 72 students are selected from the six districts). Then, using a table of random numbers, the selected people in each school are divided into three equal groups. The names of each group (control and intervention groups) are also redefined with random numbers
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 Shahid Sadoughi University of Medical Sciences
Street address
Campus of Sadoughi University of Medical Sciences, Shohadaye Gomnam Blv,Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2020-06-29, 1399/04/09
Ethics committee reference number
IR.SSU.SPH.REC.1399.075
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
2
Description of health condition studied
Overweight
ICD-10 code
E66.3
ICD-10 code description
Overweight
Primary outcomes
1
Description
Weight measurement
Timepoint
Start of study and monthly for 4 months
Method of measurement
It will be measured using standard scales and people in light clothing
2
Description
Height measurement
Timepoint
Start of study and monthly for 4 months
Method of measurement
Meter will be non-stretch and standard and people with light clothing
3
Description
Waist measurement
Timepoint
Start of study and monthly for 4 months
Method of measurement
Non-stretch and standard meters and people with light clothing will be measured standing up
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Individuals in the intervention group receive a mobile app for 16 weeks that includes daily diet, physical activity, and recommendations for changing eating behavior, and measures anthropometric indices such as height, weight, waist circumference, BMI, and BMIz each month.
Category
Lifestyle
2
Description
Control group: People in this group receive a diet printed on paper and brochures for sixteen weeks that contain daily diet, physical activity and recommendations for changing eating behavior, and anthropometric indicators such as height, weight, waist circumference each month. , BMI and BMIz are measured
Category
Lifestyle
3
Description
People in this group do not receive any information and anthropometric indicators such as height, weight, waist, BMI and BMIz are measured every month
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dastgerd Health Center
Full name of responsible person
Mahdi Mohammadian-jazi
Street address
Dastgerd Health Center Ghaemieh Street
City
Esfahan
Province
Isfehan
Postal code
8177916841
Phone
+98 31 3780 8575
Email
mahdyir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Azadeh Najarzadeh
Street address
Campus of Sadoughi University of Medical Sciences, Shohadaye Gomnam Blv,Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9104
Email
azadehnajarzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Mahdi Mohammadian-Jazi
Position
MSc of Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Hosseini Alley Vahid Street
City
Esfahan
Province
Isfehan
Postal code
8176986311
Phone
+98 31 3786 2928
Email
mahdyir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azadeh Naharzadeh
Position
PhD in Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Campus of Sadoughi University of Medical Sciences, Shohadaye Gomnam Blv,Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9104
Email
azadehnajarzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahdi Mohammadian-Jazi
Position
MSc of Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Hosseini Alley Vahid Street
City
Esfahan
Province
Isfehan
Postal code
8176986311
Phone
+98 31 3786 2928
Email
mahdyir@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data report will be shared after publishing the paper
When the data will become available and for how long
Six month after publish
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Using for Meta-analysis
From where data/document is obtainable
Nutrition Center, School of Public Health,Shahid Sadoughi University of Medical Sciences,Yazd.Tel: 009803538209100
Email: azadehnajarzadeh@gmail.com
What processes are involved for a request to access data/document
It will be sent two weeks after the receipt of the email with the consent of the co-workers