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Child Acute MalnutritionPhase 4PROMIS-MaliNCT02323815

The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Mali: a Cluster Randomized Intervention Study

A Phase 4 study testing Small-Quantity Lipid-based nutrient supplement and Child's health and nutrition topics in people with Child Acute Malnutrition, run by International Food Policy Research Institute at 1 site in Mali.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Globally, child undernutrition is the underlying cause for 3.1 million deaths of children younger than 5 years. 18.7 million children under five years of age suffer from severe acute malnutrition (SAM) and an additional 33 million children suffer from moderate acute malnutrition, and are at risk of developing SAM In… Read more about this study

Who is it for?
Ages 6 to 23 monthsHealthy volunteers can take part
Conditions the study is for
Child Acute Malnutrition
What is being tested?
Small-Quantity Lipid-based nutrient supplement and Child's health and nutrition topics
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,304 participants
Where
1 siteMali
Study dates
1 Feb 2015to 1 Sep 2017
Phase
Phase 4
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

  • At least one index child 6-23 months of age in the household
  • Mother should be living in the study area since the index child's delivery
  • Singleton infants
  • Child 6-6.9 months of age;
  • Child with WHZ>-2 and MUAC>125 mm and no bilateral pitting edema
  • Mother should be living in the study area since the index child's delivery
  • Singleton infants

Who cannot join

  • Index child should not present congenital deformations that hamper anthropometric measurements
  • Longitudinal study
  • Congenital malformations that make anthropometric measurements impossible
  • Mother planning to leave the study are in the coming year

Trial locations and contacts

1 site in 1 country.

Mali1 site

  • Bla and San Health Districts

    Bla and San, Ségou

Other trials in Mali

About this study

Globally, child undernutrition is the underlying cause for 3.1 million deaths of children younger than 5 years. 18.7 million children under five years of age suffer from severe acute malnutrition (SAM) and an additional 33 million children suffer from moderate acute malnutrition, and are at risk of developing SAM

In Sub-Saharan Africa, there is often poor integration between programs to treat child acute malnutrition and programs that focus on the prevention of acute and chronic undernutrition - resulting in many missed opportunities for using prevention platforms to screen and refer SAM children, or for using screening and referral platforms to provide prevention services.

This project will address two critical gaps related to the integration of preventive and treatment programs: 1) screening and treatment of MAM/SAM have not yet been systematically integrated into routine health-center visits or mainstreamed into community outreach programs; and 2) screening programs do not offer any preventive services for those children found not to be suffering from MAM/SAM at the time of screening; mothers of children identified as non-MAM/SAM case are usually sent home without receiving any health or nutrition inputs and as a result, may fail to come back for screening because they do not see any tangible benefit associated with their participation in the screening. This project will specifically address these gaps by assessing the effect of an integrated approach consisting of higher screening coverage and preventive Behavior Change Communication (BCC) + Small-Quantity Lipid-based Nutrient supplementation (SQ-LNS) on both prevention and treatment of child undernutrition.

Read the detailed description

Because of the intended dual role of BCC/SQ-LNS on child undernutrition in this study - e.g. to help prevent child undernutrition and enhance the coverage of screening, referral and treatment of SAM/MAM, it is necessary to combine two study designs to rigorously evaluate the impact of the proposed intervention and to tease out the contribution of prevention and enhanced coverage/treatment to the overall impact on child malnutrition.

The proposed study will therefore use two types of study designs. The first one is a repeated cross-sectional design that will compare select study outcomes between intervention and control groups at endline, after 24 months of program implementation. These cross-sectional surveys among children 6-23 months, at baseline and after 24 months (on different children) will be used to assess the impact of the intervention on the prevalence of several outcomes, including the prevalence of MAM/SAM and stunting, the coverage of MAM/SAM screening and maternal ENA/IYCF/WASH knowledge and practices. The second study design entails a longitudinal design whereby individual children will be recruited at 6 months of age and followed-up monthly until they reach 24 months of age.This design will allow us to assess the intervention's effects on the incidence, recovery and recurrence rates of MAM/SAM.

Being tested
Small-Quantity Lipid-based nutrient supplement, Child's health and nutrition topics
Keywords
child acute malnutrition prevention, behavior change communication, lipid-based nutrient supplement, screening coverage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Small-Quantity Lipid-based nutrient supplementDietary supplement

    Also called SQ-LNS

    A monthly dose of SQ-LNS (31 sachets of 20g) will be distributed to mothers attending counselling sessions

  • Child's health and nutrition topicsBehavioural

    Monthly group counselling meetings organized at village level. Caregivers of participating children are invited to attend monthly counselling meetings that treat topics on child nutrition, health, hygiene and good sanitary practices. During these visits children are also screened for acute malnutrition measuring arm circumference.

Study groups in NCT02323815
Study groupRoleWhat they receive
ControlActive comparatorBehavior change communication (BCC) on Essential Nutrition Actions (ENA), Infant and Young Child Feeding (IYCF) and Water, sanitation and hygiene (WASH) is provided during monthly meetings for children 6-23 months of age
Receives: Behavioral: Child's health and nutrition topics
PROMIS interventionExperimental* Behavior change communication (BCC) on Essential Nutrition Actions (ENA), Infant and Young Child Feeding (IYCF) and Water, sanitation and hygiene (WASH) is provided during monthly meetings for children 6-23 months of age * Caregivers with children 6-23 months of age that attend Counselling meetings will be provided with a monthly dose of SQ-LNS (20g/day)
Receives: Dietary Supplement: Small-Quantity Lipid-based nutrient supplement; Behavioral: Child's health and nutrition topics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 6-23 months of age

    • Cross-sectional study
    • To calculate WHZ scores the 2006 WHO growth reference will be used

    Measured: After 24 months of program implementation

  2. Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 6-23 months)

    • Cross-sectional study
    • Longitudinal study

    Measured: monthly from study inclusion at 6 months to 23 months of age and at study endline

  3. Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm

    • Longitudinal study
    • To calculate WHZ scores the 2006 WHO growth reference will be used

    Measured: Monthly from study inclusion at 6 months to 23 months of age

  4. Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted)

    • Cross-sectional study
    • Longitudinal study

    Measured: monthly from study inclusion at 6 months to 23 months of age and at study endline

Secondary outcomes (17)

  1. Prevalence of child stunting defined by HAZ<-2 in children 6-23 months of age

    To calculate HAZ scores the 2006 WHO growth reference will be used

    Measured: After 24 months of program implementation

  2. Mean WHZ-score in children 6-23 months of age

    To calculate WHZ scores the 2006 WHO growth reference will be used

    Measured: After 24 months of program implementation

  3. Mean HAZ-score in children 6-23 months of age

    To calculate HAZ scores the 2006 WHO growth reference will be used

    Measured: After 24 months of program implementation

  4. Mean Mid-Upper Arm Circumference in children 6-23 months of age

    Measured: After 24 months of program implementation

  5. Mean hemoglobin concentration at endline in children 6-23 months of age

    Measured: After 24 months of program implementation

  6. Prevalence of child anemia (Hb concentration<11g.dL-1) at endline in children 6-23 months of age

    Measured: After 24 months of program implementation

  7. Prevalence of Severe Acute Malnutrition defined by a WHZ<-3 or bilateral pitting edema or a MUAC<115mm

    To calculate WHZ scores the 2006 WHO growth reference will be used

    Measured: After 24 months of program implementation

  8. Prevalence of severe stunting defined by a HAZ<-3 in children 6-23 months of age

    To calculate HAZ scores the 2006 WHO growth reference will be used

    Measured: After 24 months of program implementation

  9. Caregiver's knowledge and practices related to Infant and Young Child Feeding (IYCF), Essential Nutrition Actions (ENA) and Water, Sanitation and Hygiene (WASH)

    Measured: After 24 months of program implementation

  10. Incidence of child stunting defined by HAZ<-2 in children from 6 to 23 months of age

    To calculate HAZ scores the 2006 WHO growth reference will be used

    Measured: monthly from inclusion at 6 months to 23 months of age

  11. Linear growth velocity (HAZ increment/month)

    To calculate HAZ scores the 2006 WHO growth reference will be used

    Measured: monthly from inclusion at 6 months to 23 months

  12. Ponderal growth velocity (WHZ increment/month)

    To calculate WHZ scores the 2006 WHO growth reference will be used

    Measured: monthly from inclusion at 6 months to 23 months

  13. Weight gain (weight increment/month)

    Measured: monthly from inclusion at 6 months to 23 months

  14. Mid-Upper Arm Circumference gain (MUAC increment /month)

    Measured: monthly from inclusion at 6 months to 23 months

  15. Infant morbidity (acute respiratory infections, fever, malaria (RDT), vomiting, diarrhea)

    Malaria will be tested in case of fever (or recalled fever over last 24 hrs) using rapid tests

    Measured: monthly from inclusion at 6 months to 23 months

  16. Relapse rate after treatment of MAM/SAM (proportion WHZ<-2 or MUAC<125mm or bilateral pitting edema after discharge from MAM or SAM treatment program over a total number of children treated

    Measured: monthly from inclusion at 6 months to 23 months

  17. Child development (motor, language and personal-social development)

    Determined by DMC-II

    Measured: After 24 months of program implementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2014 (estimated)
  2. Study start1 Feb 2015
  3. Primary completion5 May 2017
  4. Study completion1 Sep 2017

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,304 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02323815
Sponsor's protocol ID
IFPRI
Acronym
PROMIS-Mali
Status last verified
Mar 2018
First submitted
18 Dec 2014
Last updated
9 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • Huybregts L, Le Port A, Becquey E, Zongrone A, Barba FM, Rawat R, Leroy JL, Ruel MT. Impact on child acute malnutrition of integrating small-quantity lipid-based nutrient supplements into community-level screening for acute malnutrition: A cluster-randomized controlled trial in Mali. PLoS Med. 2019 Aug 27;16(8):e1002892. doi: 10.1371/journal.pmed.1002892. eCollection 2019 Aug.

    PubMed 31454356

  • Huybregts L, Becquey E, Zongrone A, Le Port A, Khassanova R, Coulibaly L, Leroy JL, Rawat R, Ruel MT. The impact of integrated prevention and treatment on child malnutrition and health: the PROMIS project, a randomized control trial in Burkina Faso and Mali. BMC Public Health. 2017 Mar 9;17(1):237. doi: 10.1186/s12889-017-4146-6.

    PubMed 28274214

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Small-Quantity Lipid-based nutrient supplement and Child's health and nutrition topics in people with Child Acute Malnutrition, run by International Food Policy Research Institute at 1 site in Mali.

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 7 inclusion and 4 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 9 Mar 2018. 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 Mali. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 6-23 months of age (time frame: After 24 months of program implementation). The study lists 4 primary outcomes in all. 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 NCT02323815, which also lists 2 linked publications.

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 9 Mar 2018.

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