Growth FailureNCT02136966
Joint Infant and Young Child Nutrition Program and Malnutrition Prevention
A study testing MNP + IYCN counseling + cooking demonstrations in people with Growth Failure and Good Infant and Young Child Feeding Practices, run by Institut de Recherche en Sciences de la Sante, Burkina Faso at 1 site in Burkina Faso.
Trial summary
Study title: Joint Infant and young children nutrition program in Burkina Faso: Impact evaluation Hypothesis: The fortification of complementary foods associated with a counseling on feeding practices for infants and young children prevents malnutrition in 6-23 months-old children. Read more about this study
- Who is it for?
- Ages 6 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Growth Failure, Good Infant and Young Child Feeding Practices
- What is being tested?
- MNP + IYCN counseling + cooking demonstrations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,212 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Nov 2014to Dec 2015
- 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 6 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mothers of 6 to 23 months old children
- Reside in the study area
- Accept to use MNP
Who cannot join
- Mothers of children aged less than 6 months or more than 23 months.
- Refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Joint Infant and Young Child Nutrition Program in Burkina Faso : Impact Evaluation
Study title: Joint Infant and young children nutrition program in Burkina Faso: Impact evaluation Hypothesis: The fortification of complementary foods associated with a counseling on feeding practices for infants and young children prevents malnutrition in 6-23 months-old children.
Objective: to assess the effectiveness of a promotional care package in preventing malnutrition among children aged 6-23 months.
Read the detailed description
The 'Institut de Recherche en Sciences de la Santé (IRSS)', in collaboration with Micronutrient Initiative (MI), the Institute of Tropical Medicine (ITM) Antwerp (Belgium), and the Health District of Tougan, will conduct a study to assess the effectiveness of a promotional package in the prevention and management of malnutrition among children aged 6-23 months.
This promotional package includes:
- A monthly follow-up sessions promoting growth in which detailed advice on feeding practices infant and young child feeding (IYCF) will be given to the mothers of children 6-23 months . These behavioral change informations be developed based on the rapid assessment of practices and foods available in the community and adaptation of the WHO manual.
- The distribution of micronutrient powders (MNP) (15 micronutrients) to mothers of children 6-23 months of age for home fortification of complementary foods
- Intensive counseling sessions and cooking demonstrations every two weeks for moderately malnourished children . Cooking demonstrations will include instructions on adding micronutrient powders and oil to meals .
- Being tested
- MNP + IYCN counseling + cooking demonstrations
- Medical subject headings
- Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNP + IYCN counseling + cooking demonstrationsOther
Growth monitoring and promotion sessions will take place every month at village level for all children 0-23 months of age and will serve as an entry point for all the interventions. During these sessions children under 24 months will be weighed monthly and screened for MAM and uncomplicated SAM for treatment in the community as well as complicated SAM for referral to health facility During the monthly sessions cooking demonstrations will take place in which the community Health workers will instruct the mother how to prepare a good complementary food for 6-23 months olds adding the MNP. These meals will be given to the child during the session. Mothers will be encouraged to prepare the same meal at home During the monthly sessions enhanced IYCN counseling will be given to the mothers of 6-23 months olds, using improved BCI messages developed based on the rapid assessment of practices and foods available in the community and adaptation of the WHO manual.
| Study group | Role | What they receive |
|---|---|---|
| Programme | Experimental | * Distribution of Micronutrients powders (MNP)
* Intensive counseling on Infant and Young Child Nutrition
* Cooking demonstrations Receives: Other: MNP + IYCN counseling + cooking demonstrations |
| Controle | No intervention | * Usual Infant growth monitoring and promotion activities * No distribution of micronutrients powders * No Intensive counseling * No cooking demonstrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children with Weight-for-height and/or Height-for-age ZScore <-2
Measured: 1 year
Secondary outcomes (1)
Proportion of mothers who can describe at least 3 best practices about IYCN
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche en Sciences de la Sante, Burkina Faso
- Sponsor type
- Other government
- Collaborators
- Micronutrient Initiative, Institute of Tropical Medicine, Belgium, Terre des Hommes
- Responsible party
- Principal investigator, Hermann Lanou, Institut de Recherche en Sciences de la Sante, Burkina Faso
- Investigators
- Hermann Lanou, MSc, Principal investigator, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, Burkina Faso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136966
- Sponsor's protocol ID
- IRSS0002
- Status last verified
- Apr 2016
- First submitted
- 6 May 2014
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lanou HB, Osendarp SJM, Argaw A, De Polnay K, Ouedraogo C, Kouanda S, Kolsteren P. Micronutrient powder supplements combined with nutrition education marginally improve growth amongst children aged 6-23 months in rural Burkina Faso: A cluster randomized controlled trial. Matern Child Nutr. 2019 Oct;15(4):e12820. doi: 10.1111/mcn.12820. Epub 2019 Jun 10.
PubMed 30941887
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Infant and Young Child Nutrition Program in Burkina Faso : Impact Evaluation
- ClinicalTrials.gov ID
- NCT02136966
- Acronym / sponsor ID
- IRSS0002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,212 participants (actual)
- Lead sponsor
- Institut de Recherche en Sciences de la Sante, Burkina FasoOther government
- Collaborators
- Micronutrient Initiative, Institute of Tropical Medicine, Belgium, Terre des Hommes
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 May 2014 (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.
Study title: Joint Infant and young children nutrition program in Burkina Faso: Impact evaluation Hypothesis: The fortification of complementary foods associated with a counseling on feeding practices for infants and young children prevents malnutrition in 6-23 months-old children.
Objective: to assess the effectiveness of a promotional care package in preventing malnutrition among children aged 6-23 months.
Detailed description
The 'Institut de Recherche en Sciences de la Santé (IRSS)', in collaboration with Micronutrient Initiative (MI), the Institute of Tropical Medicine (ITM) Antwerp (Belgium), and the Health District of Tougan, will conduct a study to assess the effectiveness of a promotional package in the prevention and management of malnutrition among children aged 6-23 months.
This promotional package includes:
- A monthly follow-up sessions promoting growth in which detailed advice on feeding practices infant and young child feeding (IYCF) will be given to the mothers of children 6-23 months . These behavioral change informations be developed based on the rapid assessment of practices and foods available in the community and adaptation of the WHO manual.
- The distribution of micronutrient powders (MNP) (15 micronutrients) to mothers of children 6-23 months of age for home fortification of complementary foods
- Intensive counseling sessions and cooking demonstrations every two weeks for moderately malnourished children . Cooking demonstrations will include instructions on adding micronutrient powders and oil to meals .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Programme | Experimental | Other: MNP + IYCN counseling + cooking demonstrations* Distribution of Micronutrients powders (MNP) * Intensive counseling on Infant and Young Child Nutrition * Cooking demonstrations |
| Controle | No intervention | –* Usual Infant growth monitoring and promotion activities * No distribution of micronutrients powders * No Intensive counseling * No cooking demonstrations |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Mothers of 6 to 23 months old children
- Reside in the study area
- Accept to use MNP
Key exclusion criteria (2 listed)
- Mothers of children aged less than 6 months or more than 23 months.
- Refusal
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 |
|---|---|---|
| MNP + IYCN counseling + cooking demonstrationsGrowth monitoring and promotion sessions will take place every month at village level for all children 0-23 months of age and will serve as an entry point for all the interventions. During these sessions children under 24 months will be weighed monthly and screened for MAM and uncomplicated SAM for treatment in the community as well as complicated SAM for referral to health facility During the monthly sessions cooking demonstrations will take place in which the community Health workers will instruct the mother how to prepare a good complementary food for 6-23 months olds adding the MNP. These meals will be given to the child during the session. Mothers will be encouraged to prepare the same meal at home During the monthly sessions enhanced IYCN counseling will be given to the mothers of 6-23 months olds, using improved BCI messages developed based on the rapid assessment of practices and foods available in the community and adaptation of the WHO manual. | Other | Programme |
Primary outcome
Proportion of children with Weight-for-height and/or Height-for-age ZScore <-2
Time frame: 1 year
1 secondary outcome
Proportion of mothers who can describe at least 3 best practices about IYCN
Time frame: 3, 6 and 12 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 14 Apr 2016.
- Derived from this study: PubMed 30941887Lanou HB, Osendarp SJM, Argaw A, De Polnay K, Ouedraogo C, Kouanda S, Kolsteren P. Micronutrient powder supplements combined with nutrition education marginally improve growth amongst children aged 6-23 months in rural Burkina Faso: A cluster randomized controlled trial. Matern Child Nutr. 2019 Oct;15(4):e12820. doi: 10.1111/mcn.12820. Epub 2019 Jun 10.
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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.
Hermann Lanou, MSc principal investigator
Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, Burkina Faso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MNP + IYCN counseling + cooking demonstrations in people with Growth Failure and Good Infant and Young Child Feeding Practices, run by Institut de Recherche en Sciences de la Sante, Burkina Faso at 1 site in Burkina Faso.
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 3 inclusion and 2 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 14 Apr 2016. 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 Burkina Faso. 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?
Proportion of children with Weight-for-height and/or Height-for-age ZScore <-2 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02136966, which also lists 1 linked publication.
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 14 Apr 2016.