NCT03468114

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
880

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

March 26, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

1.1 years

First QC Date

March 5, 2018

Last Update Submit

August 20, 2019

Conditions

Enteric InfectionsDiarrhea

Outcome Measures

Primary Outcomes (2)

  • Enteric infection prevalence

    Enteric infections are defined as the presence of enteric pathogens in stool as indicated by 1 or more of these 23 genetic sequences: Shigella/EIEC virulence plasmid, EAEC\_aaic, EAEC\_aata, EPEC\_eae, EPEC\_bfpa, ETEC\_LT, ETEC\_STp\_STh, EHEC Escherichia coli 0157, Aeromonas, Vibrio cholerae, Campylobacter jejuni/C. coli, Clostridium difficile, and Salmonella enterica), Adenovirus 40/41, Adenovirus Hexon, Norovirus GI, Norovirus GII, and Rotavirus and broad reactive Cryptosporidium\_18s, C. hominus, C. parvum, and Giardia assemblages A \& B.

    At 37 weeks of age (+/- 1 week)

  • Diarrhoeal disease longitudinal prevalence

    Longitudinal prevalence is defined by days with diarrhoea during follow-up with diarrhoea defined according to WHO definition (3 or more loose or liquid stools passed within 24 hours)

    Between 22 and 37 weeks of age (+/- 1 week)

Other Outcomes (1)

  • All-cause mortality incidence

    Between 22 and 37 weeks of age (+/- 1 week)

Study Arms (2)

Intervention

EXPERIMENTAL

Participant households will receive 4 visits by health extension workers delivering intervention

Behavioral: Safe Start

Control

ACTIVE COMPARATOR

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

Behavioral: Active Control

Interventions

Safe StartBEHAVIORAL

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).

Intervention
Active ControlBEHAVIORAL

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

Control

Eligibility Criteria

Age21 Weeks - 23 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infant is 21-23 weeks of age at enrolment
  • Infant's mother residing within catchment of participating health extension worker at time of enrolment and intends to stay in current dwelling at least until infant reaches 37 weeks of age

You may not qualify if:

  • Infant with any medical, psychiatric or social condition which, in the opinion of the research team, impedes the participant's ability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Great Lakes University Kisumu

Kisumu, Kenya

Location

Related Publications (2)

  • Baker KK, Mumma JAO, Simiyu S, Sewell D, Tsai K, Anderson JD, MacDougall A, Dreibelbis R, Cumming O. Environmental and behavioural exposure pathways associated with diarrhoea and enteric pathogen detection in 5-month-old, periurban Kenyan infants: a cross-sectional study. BMJ Open. 2022 Oct 31;12(10):e059878. doi: 10.1136/bmjopen-2021-059878.

    PMID: 36316067DERIVED

  • Mumma J, Simiyu S, Aseyo E, Anderson J, Czerniewska A, Allen E, Dreibelbis R, Baker KK, Cumming O. The Safe Start trial to assess the effect of an infant hygiene intervention on enteric infections and diarrhoea in low-income informal neighbourhoods of Kisumu, Kenya: a study protocol for a cluster randomized controlled trial. BMC Infect Dis. 2019 Dec 19;19(1):1066. doi: 10.1186/s12879-019-4657-0.

    PMID: 31856747DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Oliver Cumming, MSc

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

  • Jane Mumma, PhD

    Great Lakes University Kisumu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Outcome assessors are not informed of allocation but would likely infer this from the presence of highly visible domestic products that are part of the intervention. Lab technicians and data analysts are masked to allocation status.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 16, 2018

Study Start

March 26, 2018

Primary Completion

May 9, 2019

Study Completion

June 22, 2019

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations

KE(1)