- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02427945
Leveraging an Existing Large-scale Safe Water Program to Deliver Nutrition Messages at a Low Marginal Cost
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Busia County
-
Busia, Busia County, Kenya
- Evidence Action
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control
Provision of information on safe water
|
A promoter from Evidence Action will visit the household and provide information on safe water.
|
|
Experimental: Treatment traditional
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.
|
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.
|
|
Experimental: Treatment couple
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Height-for-age z-score
Time Frame: Up to 18 months
|
Up to 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge of child nutrition issues measured using a structured questionnaire
Time Frame: Up to 18 months
|
Measured using a structured questionnaire
|
Up to 18 months
|
|
Child nutritional intake measured using a 7 day Food Frequency Questionnaire
Time Frame: Up to 18 months
|
Measured using a 7 day Food Frequency Questionnaire
|
Up to 18 months
|
|
Child's age when breastfeeding stops measured using a structured questionnaire
Time Frame: Up to 18 months
|
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)
Time Frame: Up to 18 months
|
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
|
|
Probability that the child suffers from bipedal oedema
Time Frame: Up to 18 months
|
Up to 18 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Household food consumption measured using a structured questionnaire
Time Frame: Up to 18 months
|
Measured using a structured questionnaire
|
Up to 18 months
|
|
Household consumption measured using a structured questionnaire
Time Frame: Up to 18 months
|
Measured using a structured questionnaire
|
Up to 18 months
|
|
Total Chlorine Residual score
Time Frame: Up to 18 months
|
Up to 18 months
|
|
|
Labor supply measured using a structured questionnaire
Time Frame: Up to 18 months
|
Measured using a structured questionnaire
|
Up to 18 months
|
|
Time cooking on the day prior to the interview measured using a structured questionnaire
Time Frame: Up to 18 months
|
Measured using a structured questionnaire
|
Up to 18 months
|
|
Women's empowerment measured using a structured questionnaire
Time Frame: Up to 18 months
|
Measured using a structured questionnaire
|
Up to 18 months
|
|
Probability of having a chat with a friend or acquaintance about food or nutrition measured using a structured questionnaire
Time Frame: Up to 18 months
|
Measured using a structured questionnaire.
Having a chat in the last 3 days prior to the survey interview.
|
Up to 18 months
|
|
Probability of child suffering from diarrhea measured using a structured questionnaire
Time Frame: Up to 18 months
|
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
|
|
Hygiene practices measured using a structured questionnaire
Time Frame: Up to 18 months
|
Measured using a structured questionnaire
|
Up to 18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marcos Vera-Hernandez, PhD, research fellow
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1827/006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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