Evaluating Impact of Improved Floors on Health

NCT05914363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2200

Last updated 2025-01-30

No results posted yet for this study

Summary

The goal of this intervention study is to learn about the impact of household flooring on health in rural Kenya, and test whether providing an improved (cement stabilised, washable) floor improves the health of children and their care providers.

The main questions the study aims to answer are:

* What is the effect of providing a sealed, washable floor on the prevalence of infections that cause diarrhoea, intestinal worms and sand flea infections?
* To what extent does the intervention reduce contamination of floors with pathogens within the home?
* What is its effect of the intervention on the wellbeing of caregivers and children?
* Over the course of a year, do the new floors remain undamaged, with no cracks?
* Do participants living with the new floors, and the masons that helped to install the floors, like them and feel they are practical and affordable?

The study will involve a trial, where half of the recruited households will be randomly chosen to receive the new floor in addition to some support on how to care for the floor and keep it clean. The other half of households will not receive anything at first, but at the end of the research project will also receive a new floor.

Before the new floors are installed, the investigators will make several assessments in all study households. These will include a survey to measure household characteristics; a stool survey, to measure how many people are infected with diarrhoea-causing microorganisms and parasitic worms; a jigger flea examination among children; wellbeing assessments among children and caregivers; and soil sampling to identify microorganisms on the floor of the household.

When households receive the new floor, participants will have to move out of their house for up to 7 days during installation. Participants will also be asked to attend some group meetings to discuss ways of taking care of the floor and keeping it clean.

Assessments will be repeated 12 months after the floor has been delivered, and additional interviews will be held with a small number of randomly selected participants. Throughout the 12 months following delivery of the intervention, investigators will make unannounced visits to households to check the condition of the floor. Participants will also be offered treatment for parasitic worm infections after assessments have been completed at the start and end of the project.

Conditions

  • Diarrhoeal Disease
  • Hookworm Infection
  • Ascaris Lumbricoides Infection
  • Trichuris Infection
  • Tungiasis

Interventions

OTHER

Sealed washable floor plus behaviour change

Replacement of rudimentary floors with a cement stabilised floor in all rooms in the dwelling

BEHAVIORAL

Behaviour change intervention

Support for behaviour change through 'floor clubs' and the provision of printed guides

DRUG

Routine deworming

Treatment of all household members for STH infections (400 mg albendazole in those aged 24 months and above; 200 mg albendazole in those aged 12-23 months)

PROCEDURE

treatment for tungiasis

Treatment of tungiasis in those affected by heavy infections (at 0 and 12 months) according to county Department of Health recommendations

Sponsors & Collaborators

  • Kenya Medical Research Institute

    collaborator OTHER
  • Jomo Kenyatta University of Agriculture and Technology

    collaborator OTHER
  • International Centre of Insect Physiology and Ecology (ICIPE)

    collaborator OTHER
  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Rachel Pullan, PhD · London School of Hygiene and Tropical Medicine

  • Ulrike Fillinger, PhD · icipe

  • Charles Mwandawiro, PhD · Kenya Medical Research Institute

  • James Wambua KALULI, PhD · JKUAT

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-12
Primary Completion
2024-08-31
Completion
2024-09-30

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05914363 on ClinicalTrials.gov