Fit Plus: Assessing the Impact of a School-based Intervention on Toilet Quality

March 9, 2018 updated by: London School of Hygiene and Tropical Medicine

A Randomised Control Trial of a Sanitation Operation and Management Intervention in Elementary Schools in the Philippines (Fit for School Plus)

This study will assess the impact of a school-based water, sanitation, and hygiene management intervention on toilet use and pupil handwashing in the Philippines.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8687

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Attending study school on day of observation

Exclusion Criteria:

  • No predefined exclusion criteria since individual-level data is not recorded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fit Plus
The experimental arm will receive the Fit For School expanded intervention, which addresses pupil handwashing, toothbrushing, and school sanitation maintenance. Interventions will begin in July 2017.
Other: FIT Plus
  • Group handwashing facilities
  • Daily group handwashing and toothbrushing activities
  • Sanitation operation and maintenance manuals for school officials
  • Toilet cleaning consumable
  • Toilet and handwashing station maintenance kits
  • Soap, toothbrushes, and toothpaste
Active Comparator: Comparator
This group will receive the Fit Plus intervention after the trial is complete (January 2017)
Other: Comparator arm
This is the same intervention as FIT Plus, but will be delivered to schools following endline data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toilet Usability Index
Time Frame: 5 months after intervention delivery
The Toilet Usability Index is a composite score based on toilet availability, accessibility, and privacy collected through direct observation of facilities.
5 months after intervention delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soap Use Ratio
Time Frame: 5 months after intervention delivery
The secondary outcome measure is the soap-use ratio per toilet, which will be calculated based on the weight of soap used in one day divided by the number of toileting events in the same day.
5 months after intervention delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

Academic Centre for Dentistry in Amsterdam
Deutsche Gesellshaft fur Internationale Zusammenarbeit (GIZ) GMBH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2017

Primary Completion (Actual)

November 30, 2017

Study Completion (Actual)

November 30, 2017

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

June 28, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 12238

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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