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Trial record 1 of 1 for:    NCT02323815
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The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Mali: a Cluster Randomized Intervention Study (PROMIS-Mali)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Helen Keller International
Information provided by (Responsible Party):
International Food Policy Research Institute
ClinicalTrials.gov Identifier:
NCT02323815
First received: December 18, 2014
Last updated: March 21, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention Phase
Child Acute Malnutrition
Dietary Supplement: Small-Quantity Lipid-based nutrient supplement
Behavioral: Child's health and nutrition topics
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Mali: a Cluster Randomized Intervention Study

Resource links provided by NLM:


Further study details as provided by International Food Policy Research Institute:

Primary Outcome Measures:
  • 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 ]
    • Cross-sectional study
    • To calculate WHZ scores the 2006 WHO growth reference will be used

  • Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 6-23 months) [ Time Frame: monthly from study inclusion at 6 months to 23 months of age and at study endline ]
    • Cross-sectional study
    • Longitudinal study

  • Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm [ Time Frame: Monthly from study inclusion at 6 months to 23 months of age ]
    • Longitudinal study
    • To calculate WHZ scores the 2006 WHO growth reference will be used

  • Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted) [ Time Frame: monthly from study inclusion at 6 months to 23 months of age and at study endline ]
    • Cross-sectional study
    • Longitudinal study


Secondary Outcome Measures:
  • Prevalence of child stunting defined by HAZ<-2 in children 6-23 months of age [ Time Frame: After 24 months of program implementation ]
    To calculate HAZ scores the 2006 WHO growth reference will be used

  • Mean WHZ-score in children 6-23 months of age [ Time Frame: After 24 months of program implementation ]
    To calculate WHZ scores the 2006 WHO growth reference will be used

  • Mean HAZ-score in children 6-23 months of age [ Time Frame: After 24 months of program implementation ]
    To calculate HAZ scores the 2006 WHO growth reference will be used

  • Mean Mid-Upper Arm Circumference in children 6-23 months of age [ Time Frame: After 24 months of program implementation ]
  • Mean hemoglobin concentration at endline in children 6-23 months of age [ Time Frame: After 24 months of program implementation ]
  • Prevalence of child anemia (Hb concentration<11g.dL-1) at endline in children 6-23 months of age [ Time Frame: After 24 months of program implementation ]
  • Prevalence of Severe Acute Malnutrition defined by a WHZ<-3 or bilateral pitting edema or a MUAC<115mm [ Time Frame: After 24 months of program implementation ]
    To calculate WHZ scores the 2006 WHO growth reference will be used

  • Prevalence of severe stunting defined by a HAZ<-3 in children 6-23 months of age [ Time Frame: After 24 months of program implementation ]
    To calculate HAZ scores the 2006 WHO growth reference will be used

  • Caregiver's knowledge and practices related to Infant and Young Child Feeding (IYCF), Essential Nutrition Actions (ENA) and Water, Sanitation and Hygiene (WASH) [ Time Frame: After 24 months of program implementation ]
  • Incidence of child stunting defined by HAZ<-2 in children from 6 to 23 months of age [ Time Frame: monthly from inclusion at 6 months to 23 months of age ]
    To calculate HAZ scores the 2006 WHO growth reference will be used

  • Linear growth velocity (HAZ increment/month) [ Time Frame: monthly from inclusion at 6 months to 23 months ]
    To calculate HAZ scores the 2006 WHO growth reference will be used

  • Ponderal growth velocity (WHZ increment/month) [ Time Frame: monthly from inclusion at 6 months to 23 months ]
    To calculate WHZ scores the 2006 WHO growth reference will be used

  • Weight gain (weight increment/month) [ Time Frame: monthly from inclusion at 6 months to 23 months ]
  • Mid-Upper Arm Circumference gain (MUAC increment /month) [ Time Frame: monthly from inclusion at 6 months to 23 months ]
  • Infant morbidity (acute respiratory infections, fever, malaria (RDT), vomiting, diarrhea) [ Time Frame: monthly from inclusion at 6 months to 23 months ]
    Malaria will be tested in case of fever (or recalled fever over last 24 hrs) using rapid tests

  • 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 [ Time Frame: monthly from inclusion at 6 months to 23 months ]

Estimated Enrollment: 2304
Study Start Date: January 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
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
Behavioral: Child's health and nutrition topics
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.
Experimental: PROMIS intervention
  • 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)
Dietary Supplement: Small-Quantity Lipid-based nutrient supplement
A monthly dose of SQ-LNS (31 sachets of 20g) will be distributed to mothers attending counselling sessions
Other Name: SQ-LNS
Behavioral: Child's health and nutrition topics
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.

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.

  Eligibility

Ages Eligible for Study:   6 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Cross-sectional study (baseline and endline)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Index child should not present congenital deformations that hamper anthropometric measurements

Longitudinal study

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Congenital malformations that make anthropometric measurements impossible
  • Mother planning to leave the study are in the coming year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02323815

Locations
Mali
Bla and San Health Districts
Bla and San, Segou, Mali
Sponsors and Collaborators
International Food Policy Research Institute
Helen Keller International
Investigators
Study Director: Marie Ruel, PhD International Food Policy Research Institute
Principal Investigator: Harouna Konde, MD Helen Keller International - Mali
Principal Investigator: Lieven Huybregts, PhD International Food Policy Research Institute
Principal Investigator: Agnes Le Port International Food Policy Research Institute
  More Information

Responsible Party: International Food Policy Research Institute
ClinicalTrials.gov Identifier: NCT02323815     History of Changes
Other Study ID Numbers: IFPRI
Study First Received: December 18, 2014
Last Updated: March 21, 2017

Keywords provided by International Food Policy Research Institute:
child acute malnutrition prevention
behavior change communication
lipid-based nutrient supplement
screening coverage

Additional relevant MeSH terms:
Malnutrition
Child Nutrition Disorders
Nutrition Disorders

ClinicalTrials.gov processed this record on March 29, 2017