NCT02427945

Brief Summary

The investigators are seeking to overcome the dual challenges of under-nutrition and diarrhea using an existing safe water supply platform to deliver nutrition information to targeted groups in Western Kenya. Using a randomized evaluation, investigators will determine the impact on nutrition status and practices of delivering nutrition information. The evaluation results will enable Evidence Action to make strategic decisions regarding the potential scale-up of the combined program across Kenya.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,671

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

2.1 years

First QC Date

April 14, 2015

Last Update Submit

March 17, 2019

Conditions

Child Malnutrition

Keywords

Information provision

Outcome Measures

Primary Outcomes (1)

  • Height-for-age z-score

    Up to 18 months

Secondary Outcomes (5)

  • Knowledge of child nutrition issues measured using a structured questionnaire

    Up to 18 months

  • Child nutritional intake measured using a 7 day Food Frequency Questionnaire

    Up to 18 months

  • Child's age when breastfeeding stops measured using a structured questionnaire

    Up to 18 months

  • A composite index of other anthropometric indicators (includes child's weight for age z-score, child's mid-upper arm circumference, and child's head circumference)

    Up to 18 months

  • Probability that the child suffers from bipedal oedema

    Up to 18 months

Other Outcomes (9)

  • Household food consumption measured using a structured questionnaire

    Up to 18 months

  • Household consumption measured using a structured questionnaire

    Up to 18 months

  • Total Chlorine Residual score

    Up to 18 months

  • +6 more other outcomes

Study Arms (3)

Control

EXPERIMENTAL

Provision of information on safe water

Behavioral: Provision of information on safe water

Treatment traditional

EXPERIMENTAL

Provision of information on safe water and child nutrition. The information will be targeted to the mother of the child aged between 6 and 24 months old.

Behavioral: Provision of information on safe water and child nutrition

Treatment couple

EXPERIMENTAL

Provision of information on safe water and child nutrition. The information will be targeted to the mother of the child aged between 6 and 24 months old, and her husband.

Behavioral: Provision of information on safe water and child nutrition

Interventions

Provision of information on safe waterBEHAVIORAL

A promoter from Evidence Action will visit the household and provide information on safe water.

Control
Provision of information on safe water and child nutritionBEHAVIORAL

A promoter from Evidence Action will visit the household and provide information on safe water, as well as child nutrition (including hygiene on food preparation and storage). Households will be given a poster to hang in their dwellings with basic nutrition information. The poster might be smaller and in black and white, or larger and in color.

Treatment coupleTreatment traditional

Eligibility Criteria

AgeUp to 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children will be included if they are between 0 and 18 months at baseline and live within the catchment area of a water point in which Evidence Action installs a chlorine dispenser

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evidence Action

Busia, Busia County, Kenya

Location

MeSH Terms

Conditions

Child Nutrition Disorders

Interventions

Child Nutritional Physiological Phenomena

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Marcos Vera-Hernandez, PhD

    Research Fellow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 28, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

March 19, 2019

Record last verified: 2019-03

Locations

KE(1)