UMIN-CTR Clinical Trial

Basic information
Public title	Sanitation, Health and Civic Participation of Children & Youth in Urban Slums: An action research study in Lusaka, Zambia
Acronym	Sanitation, Health and Civic Participation of Children & Youth in Urban Slum
Scientific Title	Sanitation, Health and Civic Participation of Children & Youth in Urban Slums: An action research study in Lusaka, Zambia
Scientific Title:Acronym	Sanitation, Health and Civic Participation of Children & Youth in Urban Slum
Region	Africa

Condition
Condition	health education
Classification by specialty	Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Measure the benefit of civic participation of children and youth to quality of life in the slum in Lusaka, Zambia
Basic objectives2	Others
Basic objectives -Others	Develop a means to involve children and youth in community development and behavior change
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improved health and well-being in children and youth. Awareness on community sanitation.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Give lessons on sanitation, health, civic participation, ethics and leadership
Interventions/Control_2
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	11 years-old <=
Age-upper limit	24 years-old >=
Gender	Male and Female
Key inclusion criteria	residents in 2 selected slum areas in Lusaka, Zambia
Key exclusion criteria	non-residents in the selected slum areas
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Taro Middle name Last name Yamauchi
Organization	Hokkaido University
Division name	Faculty of Health Sciences
Zip code	060-0812
Address	N12, W5, Kita-ku, Sapporo
TEL	011-706-3379
Email	taroy@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Taro Middle name Last name Yamauchi
Organization	Hokkaido University
Division name	Faculty of Health Sciences
Zip code	060-0812
Address	N12, W5, Kita-ku, Sapporo
TEL	011-706-3379
Homepage URL
Email	taroy@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University
Institute
Department

Funding Source
Organization	Research Institute for Humanity and Nature
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Faculty of Health Sciences, Hokkaido University
Address	Sapporo
Tel	0117063379
Email	shomu@hs.hokudai.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	2017 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications	https://chikyu.repo.nii.ac.jp/?action=pages_view_main&active_action=repository_view_main_item_detail
Number of participants that the trial has enrolled	150
Results	A research report based on a preliminary assessment of the research area focused on water, sanitation and hygiene
Results date posted	2019 Year 08 Month 05 Day
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	2016 Year 12 Month 14 Day
Date of IRB	2017 Year 02 Month 14 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2020 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	2017 Year 02 Month 01 Day
Last modified on	2021 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029830