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The Safe Start Trial - Kisumu, Kenya

NCT03468114 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 880

Last updated 2019-08-21

No results posted yet for this study

Summary

This a cluster randomised controlled trial (cRCT) to evaluate the effect of a novel food hygiene intervention on infant health.

Conditions

Interventions

BEHAVIORAL

Safe Start

Participant households will receive four visits over a 10 week period from health extension workers promoting safe food preparation, storage and feeding, and will be provided with products to support these practices (a bowl, spoon, cup, hand washing station, liquid soap dispenser).

BEHAVIORAL

Active Control

Participant households will receive 4 visits by health extension workers delivering standard care

Sponsors & Collaborators

  • Great Lakes University Kisumu

    collaborator OTHER

  • University of Iowa

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Oliver Cumming, MSc · London School of Hygiene and Tropical Medicine

  • Jane Mumma, PhD · Great Lakes University Kisumu

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Weeks
Max Age
23 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-26
Primary Completion
2019-05-09
Completion
2019-06-22

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Diseases

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 NCT03468114 on ClinicalTrials.gov