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The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Burkina Faso: a Cluster Randomized Intervention Study (PROMIS-BF)

Primary Purpose

Child Acute Malnutrition

Status
Completed
Phase
Phase 4
Locations
Burkina Faso
Study Type
Interventional
Intervention
LNS
Child's health and nutrition topics
National policy well-baby visits
Sponsored by
International Food Policy Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Child Acute Malnutrition focused on measuring child acute malnutrition, prevention, behavior change communication, lipid-based nutrient supplement, screening coverage

Eligibility Criteria

undefined - 17 Months (Child)All SexesAccepts Healthy Volunteers

Cross-sectional study (baseline and endline) (n=2,310)

Inclusion Criteria:

  • At least one index child 0-17 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 (n=2,180)

Inclusion Criteria:

  • child 0-1.4 months of age;
  • 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 area in the coming year
  • Children of 1.5 month of age or older at study inclusion
  • WHZ<-2 both at enrollment and at the first follow-up.

Sites / Locations

  • Gourcy Health District

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PROMIS intervention

control

Arm Description

Small group 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 well-baby visits for children 0-17 months of age Caregivers with children 0-17 months of age that attend the well-baby visit will be provided with a monthly dose of LNS (20g/day)

Monthly well-baby visits as prescribed by national policy This arm is the basic comparison arm. Caregivers are invited to frequent the health center once a month for well-baby visits. During these visits necessary vaccinations are administered, child growth and nutrition status is evaluated and preventive counseling on child nutrition and health is provided in large groups of caregivers.

Outcomes

Primary Outcome Measures

Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 0-17 months of age
Cross-sectional study To calculate WHZ scores the 2006 WHO growth reference will be used The MUAC criterion (125mm) is only used for children 6-17months of age
Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 0-17 months)
Cross-sectional study Longitudinal study
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
Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted)
Cross-sectional study Longitudinal study

Secondary Outcome Measures

Prevalence of child stunting defined by HAZ<-2 in children 0-17 months of age
To calculate HAZ scores the 2006 WHO growth reference will be used
Mean WHZ-score in children 0 -17 months of age
To calculate WHZ scores the 2006 WHO growth reference will be used
Mean HAZ-score in children 0-17 months of age
To calculate HAZ scores the 2006 WHO growth reference will be used
Mean mid-upper arm circumference in children 0-17 months of age
Mean hemoglobin concentration in children 3-17 months of age
Hemocues will be used to measure Hb concentration
Prevalence of child anemia (Hb concentration<10g/dL) in children 3 - 17 months of age
Prevalence of severe acute child malnutrition defined by a WHZ<-3 or bilateral pitting edema or a MUAC<115mm in children 0-17 months of age
The MUAC criterion (115mm) is only used for children 6-17months of age
Prevalence of severe stunting defined by a HAZ<-3 in children 0-17 months of age
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)
Incidence of child stunting defined by HAZ<-2 in children from 0 to 17 months
To calculate HAZ score the 2006 WHO growth reference will be used
Linear growth velocity (HAZ increment/month)
To calculate HAZ score the 2006 WHO growth reference will be used
Ponderal growth velocity (WHZ increment/month)
To calculate WHZ score the 2006 WHO growth reference will be used
Weight gain (weight increment/month)
Mid-upper arm circumference gain (MUAC increment/month)
Infant morbidity (acute respiratory infections, fever, malaria (RDT), vomiting, diarrhea)
Malaria will be tested in case of fever (or recalled fever over last 24hrs) use 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 total number of children treated)

Full Information

First Posted
September 16, 2014
Last Updated
March 8, 2018
Sponsor
International Food Policy Research Institute
Collaborators
Helen Keller International
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1. Study Identification

Unique Protocol Identification Number
NCT02245152
Brief Title
The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Burkina Faso: a Cluster Randomized Intervention Study
Acronym
PROMIS-BF
Official Title
The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Burkina Faso: a Cluster Randomized Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 6, 2014 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Food Policy Research Institute
Collaborators
Helen Keller International

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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 often 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.
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. A repeated cross-sectional study design among children 0-17 months, at baseline and at study endline (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 proposed study design entails a longitudinal design whereby individual children will be recruited at birth and followed-up monthly until they reach 18 months of age. We anticipate needing approximately 5 months to recruit the required number of children (estimated at 2,040- 1,020 in the control group and 1,020 in the intervention group). This design will allow us to assess the intervention's effects on the incidence, recovery and recurrence rates of MAM/SAM.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Acute Malnutrition
Keywords
child acute malnutrition, prevention, behavior change communication, lipid-based nutrient supplement, screening coverage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PROMIS intervention
Arm Type
Experimental
Arm Description
Small group 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 well-baby visits for children 0-17 months of age Caregivers with children 0-17 months of age that attend the well-baby visit will be provided with a monthly dose of LNS (20g/day)
Arm Title
control
Arm Type
Active Comparator
Arm Description
Monthly well-baby visits as prescribed by national policy This arm is the basic comparison arm. Caregivers are invited to frequent the health center once a month for well-baby visits. During these visits necessary vaccinations are administered, child growth and nutrition status is evaluated and preventive counseling on child nutrition and health is provided in large groups of caregivers.
Intervention Type
Dietary Supplement
Intervention Name(s)
LNS
Other Intervention Name(s)
Lipid-based nutrient supplement (LNS)
Intervention Description
A monthly dose of LNS (31 sachets of 20g) will be distributed to mothers attending well-baby visits and participating in small group counseling
Intervention Type
Behavioral
Intervention Name(s)
Child's health and nutrition topics
Intervention Description
After the well-baby visit. Caregivers will be invited to participate in a small group counseling or BCC (2-3 caregivers at a time). Every month a set of topics related to child's health and nutrition will be treated. These BCC sessions will be organized in an interactive way centering around the condition of the participating children.
Intervention Type
Behavioral
Intervention Name(s)
National policy well-baby visits
Primary Outcome Measure Information:
Title
Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 0-17 months of age
Description
Cross-sectional study To calculate WHZ scores the 2006 WHO growth reference will be used The MUAC criterion (125mm) is only used for children 6-17months of age
Time Frame
After 24 months of program implementation
Title
Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 0-17 months)
Description
Cross-sectional study Longitudinal study
Time Frame
monthly from study inclusion at 0 months to 17 months of age and at study endline
Title
Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm
Description
Longitudinal study To calculate WHZ scores the 2006 WHO growth reference will be used
Time Frame
monthly from study inclusion at 0 months to 17 months of age
Title
Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted)
Description
Cross-sectional study Longitudinal study
Time Frame
monthly from study inclusion at 0 months to 17 months of age and at study endline
Secondary Outcome Measure Information:
Title
Prevalence of child stunting defined by HAZ<-2 in children 0-17 months of age
Description
To calculate HAZ scores the 2006 WHO growth reference will be used
Time Frame
After 24 months of program implementation
Title
Mean WHZ-score in children 0 -17 months of age
Description
To calculate WHZ scores the 2006 WHO growth reference will be used
Time Frame
After 24 months of program implementation
Title
Mean HAZ-score in children 0-17 months of age
Description
To calculate HAZ scores the 2006 WHO growth reference will be used
Time Frame
After 24 months of program implementation
Title
Mean mid-upper arm circumference in children 0-17 months of age
Time Frame
After 24 months of program implementation
Title
Mean hemoglobin concentration in children 3-17 months of age
Description
Hemocues will be used to measure Hb concentration
Time Frame
After 24 months of program implementation
Title
Prevalence of child anemia (Hb concentration<10g/dL) in children 3 - 17 months of age
Time Frame
After 24 months of program implementation
Title
Prevalence of severe acute child malnutrition defined by a WHZ<-3 or bilateral pitting edema or a MUAC<115mm in children 0-17 months of age
Description
The MUAC criterion (115mm) is only used for children 6-17months of age
Time Frame
After 24 months of program implementation
Title
Prevalence of severe stunting defined by a HAZ<-3 in children 0-17 months of age
Description
To calculate HAZ scores the 2006 WHO growth reference will be used
Time Frame
After 24 months of program implementation
Title
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
Title
Incidence of child stunting defined by HAZ<-2 in children from 0 to 17 months
Description
To calculate HAZ score the 2006 WHO growth reference will be used
Time Frame
monthly from inclusion at 0 months to 17 months of age
Title
Linear growth velocity (HAZ increment/month)
Description
To calculate HAZ score the 2006 WHO growth reference will be used
Time Frame
monthly from inclusion at 0 months to 17 months of age
Title
Ponderal growth velocity (WHZ increment/month)
Description
To calculate WHZ score the 2006 WHO growth reference will be used
Time Frame
monthly from inclusion at 0 months to 17 months of age
Title
Weight gain (weight increment/month)
Time Frame
monthly from inclusion at 0 months to 17 months of age
Title
Mid-upper arm circumference gain (MUAC increment/month)
Time Frame
monthly from inclusion at 0 months to 17 moths of age
Title
Infant morbidity (acute respiratory infections, fever, malaria (RDT), vomiting, diarrhea)
Description
Malaria will be tested in case of fever (or recalled fever over last 24hrs) use rapid tests
Time Frame
monthly from inclusion at 0 months to 17 moths of age
Title
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 total number of children treated)
Time Frame
monthly from inclusion at 0 months to 17 months of age

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Cross-sectional study (baseline and endline) (n=2,310) Inclusion Criteria: At least one index child 0-17 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 (n=2,180) Inclusion Criteria: child 0-1.4 months of age; 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 area in the coming year Children of 1.5 month of age or older at study inclusion WHZ<-2 both at enrollment and at the first follow-up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Ruel, PhD
Organizational Affiliation
International Food Policy Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Celestin Somda, MD
Organizational Affiliation
Helen Keller International
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gourcy Health District
City
Gourcy
State/Province
Région Du Nord
Country
Burkina Faso

12. IPD Sharing Statement

Citations:
PubMed Identifier
31454347
Citation
Becquey E, Huybregts L, Zongrone A, Le Port A, Leroy JL, Rawat R, Toure M, Ruel MT. Impact on child acute malnutrition of integrating a preventive nutrition package into facility-based screening for acute malnutrition during well-baby consultation: A cluster-randomized controlled trial in Burkina Faso. PLoS Med. 2019 Aug 27;16(8):e1002877. doi: 10.1371/journal.pmed.1002877. eCollection 2019 Aug.
Results Reference
derived
PubMed Identifier
28274214
Citation
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.
Results Reference
derived

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

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