Child MalnutritionNCT02427945
Leveraging an Existing Large-scale Safe Water Program to Deliver Nutrition Messages at a Low Marginal Cost
A study testing Provision of information on safe water and Provision of information on safe water and child nutrition in people with Child Malnutrition, run by Marcos Vera Hernandez at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Ages Up to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Malnutrition
- What is being tested?
- Provision of information on safe water and Provision of information on safe water and child nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,671 participants
- Where
- 1 siteKenya
- Study dates
- May 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Child Malnutrition
- Being tested
- Provision of information on safe water, Provision of information on safe water and child nutrition
- Keywords
- Information provision
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provision of information on safe waterBehavioural
A promoter from Evidence Action will visit the household and provide information on safe water.
Provision of information on safe water and child nutritionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Provision of information on safe water Receives: 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. Receives: 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. Receives: Behavioral: Provision of information on safe water and child nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height-for-age z-score
Measured: Up to 18 months
Secondary outcomes (5)
Knowledge of child nutrition issues measured using a structured questionnaire
Measured using a structured questionnaire
Measured: Up to 18 months
Child nutritional intake measured using a 7 day Food Frequency Questionnaire
Measured using a 7 day Food Frequency Questionnaire
Measured: Up to 18 months
Child's age when breastfeeding stops measured using a structured questionnaire
Measured using a structured questionnaire
Measured: 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)
The composite index will include child's weight for age z-score, child's mid-upper arm circumference, and child's head circumference.
Measured: Up to 18 months
Probability that the child suffers from bipedal oedema
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,671 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcos Vera Hernandez
- Sponsor type
- University, hospital or other
- Collaborators
- Evidence Action, MaiMwana
- Responsible party
- Sponsor-investigator, Marcos Vera Hernandez, Institute for Fiscal Studies
- Investigators
- Marcos Vera-Hernandez, PhD, Principal investigator, Research Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427945
- Sponsor's protocol ID
- 1827/006
- Status last verified
- Mar 2019
- First submitted
- 14 Apr 2015
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging an Existing Large-scale Safe Water Program to Deliver Nutrition Messages at a Low Marginal Cost
- ClinicalTrials.gov ID
- NCT02427945
- Acronym / sponsor ID
- 1827/006
- Conditions
- Child Malnutrition
- Keywords
- Information provision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,671 participants (actual)
- Lead sponsor
- Marcos Vera HernandezUniversity, hospital or other
- Collaborators
- Evidence Action, MaiMwana
- Study start
- May 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: Provision of information on safe waterProvision of information on safe water |
| Treatment traditional | Experimental | Behavioral: Provision of information on safe water and child nutritionProvision 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. |
| Treatment couple | Experimental | Behavioral: Provision of information on safe water and child nutritionProvision 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. |
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provision of information on safe waterA promoter from Evidence Action will visit the household and provide information on safe water. | Behavioural | Control |
| Provision of information on safe water and child nutritionA 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. | Behavioural | Treatment couple, Treatment traditional |
Primary outcome
Height-for-age z-score
Time frame: Up to 18 months
5 secondary outcomes
Knowledge of child nutrition issues measured using a structured questionnaire
Time frame: Up to 18 months
Child nutritional intake measured using a 7 day Food Frequency Questionnaire
Time frame: Up to 18 months
Child's age when breastfeeding stops measured using a structured questionnaire
Time frame: 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
Probability that the child suffers from bipedal oedema
Time frame: Up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
Related trials for Child Malnutrition
Recruiting
Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition
Acute Malnutrition With no Complications
Recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
RecruitingPhase 4
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Malnutrition, Child, Malnutrition
Enrolling by invitation
Effectiveness of Positive Deviance/Hearth in Treating Uncomplicated Moderate Acute Malnutrition in Children 6-59 Months in Mymensingh Division, Bangladesh
Moderate Acute Malnutrition (MAM), Undernutrition
Not yet recruitingObservational study
Nutritional Assessment in Children With Cerebral Palsy
Malnutrition, Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcos Vera-Hernandez, PhD principal investigator
Research Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provision of information on safe water and Provision of information on safe water and child nutrition in people with Child Malnutrition, run by Marcos Vera Hernandez at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height-for-age z-score (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.