Protocol summary

Study aim
Goal and objectives: Local community readiness promotion for childhood obesity prevention in late primary school children 1. Promotion of the community efforts 2. Raising awareness of the community about available efforts and childhood obesity issue 3. Increase the level of active participation of the community leaders 4. Strengthen the community climate for childhood obesity prevention 5. Promotion of the available resources for childhood obesity prevention
Design
Four schools with the same level of preparedness for obesity prevention programs are selected, and the appropriate intervention pattern is designed based on the level of readiness of these schools and runs for six months in these schools. Four schools are controls. Then the impact of the intervention on increasing the readiness level of the four intervention schools is evaluated and compared with the control schools.
Settings and conduct
A controlled community-based intervention program in elementary schools in districts 2 and 16 of Tehran
Participants/Inclusion and exclusion criteria
Eight public elementary schools in districts 2 and 16 of the Tehran Office of Education and related municipal neighborhood houses and public health care centers are the participants of this intervention
Intervention groups
Four elementary schools in districts 2 and 16 of the Office Education of Tehran constitute intervention groups. In intervention schools, 8 key strategies (Engagement, sensitization, Encouragement, Education, Informing, Create supportive environments, Modeling, and Incentive) are implemented by the School Food and Nutrition committee in the school environment. Four schools are also in the control group and no receive any intervention.
Main outcome variables
The number of local community programs and efforts, the level of local community awareness, the involvement of local community leaders, the number of resources available

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191006044997N1
Registration date: 2019-11-11, 1398/08/20
Registration timing: registered_while_recruiting

Last update: 2019-11-11, 1398/08/20
Update count: 0
Registration date
2019-11-11, 1398/08/20
Registrant information
Name
Mahdieh Niknam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7483
Email address
ma_niknam@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-26, 1398/08/04
Expected recruitment end date
2020-04-23, 1399/02/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intervention program to promote local community readiness for childhood obesity prevention in late primary school children
Public title
Promotion of local community readiness for childhood obesity prevention in late primary school children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All public primary schools in districts 2 and 16 of Tehran Office Education that have the second course (fourth, fifth and sixth grades)
Exclusion criteria:
School staff are reluctant to participate in the intervention Students are reluctant to participate in the intervention Parents are reluctant to participate in the intervention
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 8
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, we have four intervention groups (four intervention schools) that receive the same interventions. Also, we have four control groups (4 control schools) that receive no intervention

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Nutrition and Food Technology Research Institute (NNFTRI) ethical committee
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2018-07-18, 1397/04/27
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1397.012

Health conditions studied

1

Description of health condition studied
Childhood obesity prevention
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
The number of local community's programs and efforts, the level of the local community's awareness, the involvement of local community leaders, the number of resources available
Timepoint
After determining the stage of local community readiness for childhood obesity prevention programs in selected primary schools in Tehran (before beginning the intervention), 6 months later, the stage of local community readiness for childhood obesity prevention programs is again reassessed.
Method of measurement
Semi-structured qualitative valid questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Four boys' and girls' elementary schools in districts 2 and 16 of Tehran with public health care center and municipal neighborhood house near the school constitute a local community that will be affected by 6 months intervention including 8 main strategies (Engagement, sensitization, Encouragement, Education, Informing, Create supportive environments, Modeling, and Incentive).
Category
Prevention

2

Description
Control group: Four schools (2 girls 'and boys' schools from each district) are in the control group and no recieve any intervention. Then the impact of the intervention on increasing the readiness level of the four intervention schools is evaluated and compared with the control schools.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Elemenary schools in districts 2 and 16 of Tehran Office of Education
Full name of responsible person
Mahdieh Niknam
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
ma_niknam@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Morteza Abdollahi
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
nutrition@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
50
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

2

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Zade Vakili
Street address
No. 24, Beginning of Parvaneh Ave., Yemen Street, Velenjak, Shaheed Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2569
Fax
+98 21 2241 6264
Email
info@endocrine.ac.ir
Web page address
http://endocrine.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
50
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahdieh Niknam
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Fax
Email
ma_niknam@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahdieh Niknam
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Fax
Email
ma_niknam@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahdieh Niknam
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Fax
Email
ma_niknam@sbmu.ac.ir

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
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The score of each school's readiness level (anonymously) will present at the beginning and end of the intervention
When the data will become available and for how long
Data access will begin 6 months after the publication of the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Only for systematic review and metaanalysis studies
From where data/document is obtainable
The corresponding author's email (ma-nikanam@sbmu.ac. ir)the corresponding author's phone (0098 09171393460)
What processes are involved for a request to access data/document
The data will be sent by email within a week after the request
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