Evaluating the effect of an intervention on nutrition based on a digital game with physical activity and group cognitive behavioral therapy on anthropometric and biochemical parameters in obese and overweight elementary school girls
Determining the Effect of Nutrition Intervention Based on Digital Game Plus Cognitive Behavioral Therapy and Physical Activity on Anthropometric and Biochemical Parameters in Obese and Overweight Elementary School Girls
Design
The randomized clinical trial is community-based, practice-oriented control group, with parallel groups,
Settings and conduct
In this study, Shiraz will be divided into 3 districts according to urban geographic regions ,we will accept each area as a cluster. Then we will select a school randomly from each cluster. 62 students will be selected and randomly assigned (randomized block method) into two intervention and control groups (31 in each group). This study will be performed as a randomized, controlled clinical trial for 10 weeks, and the impact of digital nutrition and psychological intervention and physical activity will be assessed. Anthropometric and biochemical measurements will be evaluated at the end of the period.
Participants/Inclusion and exclusion criteria
Obese and Overweight Elementary School Girls
Intervention groups
During 10 weeks of the intervention, digital games will
be givento children. At the beginning of the game, information about the causes of obesity, complications of obesity, amount of calories in various foods, food sorces of fiber and vitamins, banned foods during the intervention, and etc. will be presented to children in a video. In each game a person can play for no more than 45 minutes. The game is opened step-by-step, but when they enter the next stage, the previous stage can also be opened. The sports program is out of school, asking parents to obtain parental consent and set weekly hours outside the school program to bring their children to the gym. Sports program will be done under the supervision of a coach weekly.
Main outcome variables
weight
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190508043531N1
Registration date:2019-07-10, 1398/04/19
Registration timing:prospective
Last update:2019-07-10, 1398/04/19
Update count:0
Registration date
2019-07-10, 1398/04/19
Registrant information
Name
Sara Salahshoornezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 7014
Email address
salahshoor@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of an intervention on nutrition based on a digital game with physical activity and group cognitive behavioral therapy on anthropometric and biochemical parameters in obese and overweight elementary school girls
Public title
Evaluating the effect of an intervention on nutrition based on digital game with physical activity and group cognitive behavioral therapy on anthropometric and biochemical parameters in obese and overweight elementary school girl
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
8-12 years old overweight or obese school girls who can use a smart phone or tablet
Exclusion criteria:
depression
students who already have a diet
any medicine which affect body weight
students (or students' parents) who don't want to involve in this research
Age
From 9 years old to 12 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Overweight and obese students are selected using a randomized block method from the screened students from the fourth, fifth and sixth grade of selected schools (schools are selected using a cluster randomization method).
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 Shiraz University of Medical Sciences
Street address
Nutrition and Food Science College, Razi Blvd.,Shiraz,Iran
City
Shiraz
Province
Fars
Postal code
7153675541
Approval date
2018-10-02, 1397/07/10
Ethics committee reference number
IR.SUMS.REC.1397.870
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
waist circumferance
Timepoint
ََAt the beginning of the study (before the intervention) and 10 weeks after the start of psychological intervention and physical activity intervention and computer game intervention.
Method of measurement
The body weight is measured and recorded at both test times, with a minimum coverage and without shoes, with a seca type scales with a minimum of 0.1 to a maximum of 150 kg and an error of 100 grams in the morning. The scale is standardized before each measurement
Secondary outcomes
1
Description
serum leptin
Timepoint
At the beginning of the study (before the intervention) and 10 weeks after the start of the intervention
Method of measurement
The leptin hormone will be measured according to the ELISA method with the help of the kit, which will be measured in accordance with the instructions and using a standard curve and control at a specified time
Intervention groups
1
Description
Intervention group: During the ten weeks of intervention, children will be provided with information on the causes of obesity, the complications of obesity, the amount of calories in various foods, sources of fiber and vitamins, banned foods during the intervention, and ... presented to students as a video game. Each week, three aerobic exercise sessions will be held for 45 minutes each student by a Master of Sport Physiology. A Master of Psychology will hold a Cognitive-Behavioral Therapy session aweek in a groups of 10 to 12 people at the school.
Category
Behavior
2
Description
Control group: In the control group, the intervention includes routine healthy nutrition education (lecture, pamphlets, etc.) for students and their parents.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz schools
Full name of responsible person
Sara Salahshoornezhad
Street address
16th alley,chamran Blvd., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
Chamran st., Shiraz,
Phone
+98 71 3647 9011
Email
salahshoor@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghaasemi
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134519780
Phone
+98 71 3235 7282
Email
vdcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sara Salahshoornezhad
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi s.t, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71372510015
Email
sara.salahshoor72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Salahshoornezhad
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi s.t, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
sara.salahshoor72@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Salahshoornezhad
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi s.t, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
sara.salahshoor72@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available