UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043772
Receipt number R000049967
Scientific Title Follow-up study of school teachers related to risk factors for non-communicable diseases, Kabul, Afghanistan
Date of disclosure of the study information 2021/04/01
Last modified on 2023/03/31 21:37:35

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Basic information

Public title

Effectiveness of school-based approach in prevention and control of non-communicable diseases, Kabul, Afghanistan

Acronym

Effectiveness of school-based approach in prevention and control of non-communicable diseases, Kabul, Afghanistan

Scientific Title

Follow-up study of school teachers related to risk factors for non-communicable diseases, Kabul, Afghanistan

Scientific Title:Acronym

Follow-up study of school teachers related to risk factors for non-communicable diseases, Kabul, Afghanistan

Region

Asia(except Japan)


Condition

Condition

Non-communicable diseases

Classification by specialty

Medicine in general Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate prevalence of NCDs; knowledge, practice and attitudes towards NCDs; and efficacy of health education program among school teachers in Afghanistan.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

blood pressure
Body mass index
Knowledge related to NCDs
lifestyles

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

3-days training related to NCDs

Interventions/Control_2

Individual counseling for health education for 2 months

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

60 years-old >

Gender

Male and Female

Key inclusion criteria

School teachers at elementary or junior-high schools in Kabul, Afghanistan
Responsible for health education at school or teaching biology or chemistry

Key exclusion criteria

Unable to communicate with local language
Unable to access to places for health examination, survey, and training

Target sample size

600


Research contact person

Name of lead principal investigator

1st name KEIKO
Middle name Nakamura
Last name NAKAMURA

Organization

Tokyo Medical and Dental University

Division name

Department of Global Health Entrepreneurship

Zip code

113-8519

Address

Yushima 1-5-45, Bunkyo-ku, Tokyo

TEL

03-5803-4048

Email

nakamura.ith@tmd.ac.jp


Public contact

Name of contact person

1st name KEIKO
Middle name Nakamura
Last name NAKAMURA

Organization

Tokyo Medical and Dental University

Division name

Department of Global Health Entrepreneurship

Zip code

113-8519

Address

Yushima 1-5-45, Bunkyo-ku, Tokyo

TEL

03-5803-4048

Homepage URL


Email

nakamura.ith@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Ministry of Public Health, Afghanistan

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Medical and Dental University, Faculty of Medicine, IRB

Address

Yushima 1-5-45, Bunkyo-ku, Tokyo

Tel

03-3813-6111

Email

syomu1.adm@tmd.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

482

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 03 Month 28 Day

Date of IRB

2021 Year 06 Month 25 Day

Anticipated trial start date

2021 Year 07 Month 15 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 03 Month 29 Day

Last modified on

2023 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049967


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name