Investigating the combined effect of nutritional education based on low-calorie foods and physical activity program on treatment of obesity and overweight among primary and secondary school students: A Randomized Trial
Investigating the combined effect of nutritional education based on low-calorie foods and physical activity program on treatment of obesity and overweight among primary and secondary school students
Design
Randomized control trial with parallel groups
Settings and conduct
This study will be conducted among all elementary and high school students in Kermanshah. The calculated sample size will be 524 people who will be divided between two intervention and control groups using random method (Block Randomization). This study will be conducted as a randomized controlled clinical trial for 8 months, and the combined effect of nutritional education and physical activity on the treatment of obesity and overweight students will be measured. Anthropometric and physical activity will be evaluated at the beginning and end of the study.
Participants/Inclusion and exclusion criteria
Obese or overweight students in elementary and high school
Intervention groups
The intervention includes three components, i.e., nutrition education (students and parents), increased physical activity, and changing environment (food items offered in schools’ canteens). Nutritionists will provide education to students, parents, and school teachers about healthy eating patterns with emphasis on the consumption of alternative and low-calorie foods, the Iranian food pyramid, and the consumption amount of each food group. Nutrition education will be imparted (a 30-minute session per week) by health instructors; physical activity will be done under the supervision of the school coaches (2 one-hour sessions per week). Parents’ education (a 1.5-hour session) will be monthly.
Main outcome variables
Body mass index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180712040438N6
Registration date:2022-11-28, 1401/09/07
Registration timing:prospective
Last update:2022-11-28, 1401/09/07
Update count:0
Registration date
2022-11-28, 1401/09/07
Registrant information
Name
Jalal Moludi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 2148
Email address
jmoludi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-11, 1401/09/20
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the combined effect of nutritional education based on low-calorie foods and physical activity program on treatment of obesity and overweight among primary and secondary school students: A Randomized Trial
Public title
Investigating the effect of nutritional and physical activity education on obesity
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Desire to cooperate
Elementary and high school students
Overweight or obese students with a high body mass index (body mass index equal to or higher than the 85th percentile)
Exclusion criteria:
Have a known neurological disease
Having major systemic diseases such as malignancies
Have known liver disease
Taking medications that affect appetite and body weight, such as corticosteroids or other supplements
Any possible injury related to the intervention during the study (such as physical harm during physical activity or following the provided diet)
Age
From 7 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
524
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study is block randomization. Each of the randomly created sequences is recorded on a card and the cards are placed in the envelopes in order.
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 Kermanshah University of Medical Sciences
Street address
Kermanshah Province, Kermanshah City, Isar Square, next to Farabi Hospital, Faculty of Nutrition Sciences and Food Industry
City
Kermanshah
Province
Kermanshah
Postal code
6719851552
Approval date
2022-10-11, 1401/07/19
Ethics committee reference number
IR.KUMS.REC.1401.301
Health conditions studied
1
Description of health condition studied
Obesity or overweight
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Body mass index
Timepoint
The beginning of the study (before the start of the study), the 16th week and the end of the 32nd week
Method of measurement
Dividing weight (in kilograms) by the square of height (in meters)
Secondary outcomes
1
Description
Energy intake
Timepoint
The beginning of the study (before the start of the study), the 16th week and the end of the 32nd week
Method of measurement
Three-day food recording
2
Description
Waist circumference
Timepoint
The beginning of the study (before the start of the study), the 16th week and the end of the 32nd week
Method of measurement
Tape measure
3
Description
Hip circumference
Timepoint
The beginning of the study (before the start of the study), the 16th week and the end of the 32nd week
Method of measurement
Tape measure
4
Description
The thickness of the skin fold in the triceps region
Timepoint
The beginning of the study (before the start of the study), the 16th week and the end of the 32nd week
Method of measurement
Caliper
5
Description
Physical activity
Timepoint
The beginning of the study (before the start of the study), the 16th week and the end of the 32nd week
Method of measurement
International physical activity questionnaire
6
Description
Stress, anxiety and depression
Timepoint
The beginning of the study (before the start of the study), the 16th week and the end of the 32nd week
Method of measurement
Depression anxiety stress scales
7
Description
Sleep quality
Timepoint
The beginning of the study (before the start of the study), the 16th week and the end of the 32nd week
Method of measurement
Pittsburgh Sleep Quality Index
Intervention groups
1
Description
Intervention group: In the intervention group, nutrition education will be provided to overweight and obese children for 1 hour every week during the 8 months of intervention. These trainings will be with an emphasis on the consumption of alternative and low-calorie foods and the use of a healthy food plate. Students will be advised to do sports activities 3 times a week for one hour each time under the supervision of a sports coach. Educational pamphlets in the field of nutrition and following the food pyramid, as well as sports exercises, are provided to students and their parents at the beginning of the study.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Elementary and high schools
Full name of responsible person
Jalal Moludi
Street address
Kermanshah Province, Kermanshah City, Isar Square, next to Farabi Hospital, Faculty of Nutrition Sciences and Food Industry
City
Kermanshah
Province
Kermanshah
Postal code
6719851552
Phone
+98 83 3710 2003
Email
jmoludi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Cyrus Jalili
Street address
Kermanshah Province, Kermanshah City, Isar Square, next to Farabi Hospital, Faculty of Nutrition Sciences and Food Industry
City
Kermanshah
Province
Kermanshah
Postal code
6719851552
Phone
+98 83 3710 2003
Email
jmoludi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Jalal Moludi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kermanshah Province, Kermanshah City, Isar Square, next to Farabi Hospital, Faculty of Nutrition Sciences and Food Industry
City
Kermanshsh
Province
Kermanshah
Postal code
6719851552
Phone
+98 83 3710 2003
Email
jmoludi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Jalal Moludi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kermanshah Province, Kermanshah City, Isar Square, next to Farabi Hospital, Faculty of Nutrition Sciences and Food Industry
City
Kermanshah
Province
Kermanshah
Postal code
6719851552
Phone
+98 83 3710 2003
Email
jmoludi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Jalal Moludi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kermanshah Province, Kermanshah City, Isar Square, next to Farabi Hospital, Faculty of Nutrition Sciences and Food Industry
City
Kermanshah
Province
Kermanshah
Postal code
6719851552
Phone
+98 83 3710 2003
Email
jmoludi@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data collected for the primary outcomes will be shared
When the data will become available and for how long
Accessibility to data is possible 8 months after publication.
To whom data/document is available
The data will only be available for people working in academic institutions.
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers, for conducting Meta analysis
From where data/document is obtainable
Dr Jalal Moludi, Faculty of Nutrition Sciences and Food Technology, Kermanshah University of Medical Sciences, +989399516766, j.moloudi@yahoo.com
What processes are involved for a request to access data/document
Any one who request our data should provide a brief explanation of the purpose and method of their meta-analysis study. The applicant's request will be reviewed by the researchers and if all agree, the requested data will be sent to the applicant via email in the form of an Excel file. All these steps will not take more than 10 days.