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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02427945
Other study ID # 1827/006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2015
Est. completion date June 2017

Study information

Verified date March 2019
Source Institute for Fiscal Studies
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Evidence Action's Dispensers for Safe Water program currently provides access to safe water for two million people. The program would be able to leverage the existence of this service delivery platform to provide promoters with training on proper nutrition and methods for delivering these messages to target groups.

The intervention is a home visiting program that will provide nutrition advice on complementary feeding to households with children aged 6-24 months. Two types of home visits will be evaluated, a 'traditional visit mode' in which the child's mother receives the visit; and a 'couples visit mode' in which the promoter attempts to involve both the father and mother.

Households in the control group will also receive home visits by promoters but the content of the visit will be restricted to safe water. The same information on safe water will also be provided to households in the treatment group. Hence, the evaluation will measure the additional effect of providing nutrition information on top of information on safe water.

Promoters will provide advice on nutrition and food hygiene to target households, according to criteria established by Evidence Action. Following the Guiding Principles for Complementary Feeding of the Breastfed Child (PAHO/WHO 2003), the intervention will include information on the maintenance of breastfeeding, safe/hygienic preparation and storage of complementary foods, amount of complementary food needed, food consistency, meal frequency and energy density, nutrient content of complementary foods, and feeding after illness. The home visits will be modelled on the MaiMwana Infant Feeding intervention (http://www.maimwana.malawi.net/MaiMwana/Home.html) that has been taking place in Mchinji (Malawi) since 2005.

Households within the treatment group will be provided by a poster to hang in their dwellings with some basic information on nutrition. A random subset of households will be given a small poster in black and white, and the other subset of households will be give a larger color poster.


Recruitment information / eligibility

Status Completed
Enrollment 1671
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Months
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

Study Design


Intervention

Behavioral:
Provision of information on safe water
A promoter from Evidence Action will visit the household and provide information on safe water.
Provision of information on safe water and child nutrition
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.

Locations

Country Name City State
Kenya Evidence Action Busia Busia County

Sponsors (3)

Lead Sponsor Collaborator
Marcos Vera Hernandez Evidence Action, MaiMwana

Country where clinical trial is conducted

Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Other Household food consumption measured using a structured questionnaire Measured using a structured questionnaire Up to 18 months
Other Household consumption measured using a structured questionnaire Measured using a structured questionnaire Up to 18 months
Other Total Chlorine Residual score Up to 18 months
Other Labor supply measured using a structured questionnaire Measured using a structured questionnaire Up to 18 months
Other Time cooking on the day prior to the interview measured using a structured questionnaire Measured using a structured questionnaire Up to 18 months
Other Women's empowerment measured using a structured questionnaire Measured using a structured questionnaire Up to 18 months
Other Probability of having a chat with a friend or acquaintance about food or nutrition measured using a structured questionnaire Measured using a structured questionnaire. Having a chat in the last 3 days prior to the survey interview. Up to 18 months
Other Probability of child suffering from diarrhea measured using a structured questionnaire Measured using a structured questionnaire. Suffering from diarrhea in the last 7 days prior to the survey. Diarrhea is defined as having 3 loose stools in any one day and/or having blood in the stools at least once. Up to 18 months
Other Hygiene practices measured using a structured questionnaire Measured using a structured questionnaire Up to 18 months
Primary Height-for-age z-score Up to 18 months
Secondary Knowledge of child nutrition issues measured using a structured questionnaire Measured using a structured questionnaire Up to 18 months
Secondary Child nutritional intake measured using a 7 day Food Frequency Questionnaire Measured using a 7 day Food Frequency Questionnaire Up to 18 months
Secondary Child's age when breastfeeding stops measured using a structured questionnaire Measured using a structured questionnaire Up to 18 months
Secondary 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) The composite index will include child's weight for age z-score, child's mid-upper arm circumference, and child's head circumference. Up to 18 months
Secondary Probability that the child suffers from bipedal oedema Up to 18 months
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