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Trial record 1 of 1 for:    NCT02245152
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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)

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:
NCT02245152
First received: September 16, 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 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.


Condition Intervention Phase
Child Acute Malnutrition Dietary Supplement: LNS Behavioral: Child's health and nutrition topics Behavioral: National policy well-baby visits 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 Burkina Faso: 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 0-17 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
    • 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) [ Time Frame: monthly from study inclusion at 0 months to 17 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 0 months to 17 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 0 months to 17 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 0-17 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 0 -17 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 0-17 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 0-17 months of age [ Time Frame: After 24 months of program implementation ]
  • Mean hemoglobin concentration in children 3-17 months of age [ Time Frame: After 24 months of program implementation ]
    Hemocues will be used to measure Hb concentration

  • Prevalence of child anemia (Hb concentration<10g/dL) in children 3 - 17 months of age [ Time Frame: After 24 months of program implementation ]
  • 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 [ Time Frame: After 24 months of program implementation ]
    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 [ 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 0 to 17 months [ Time Frame: monthly from inclusion at 0 months to 17 months of age ]
    To calculate HAZ score the 2006 WHO growth reference will be used

  • Linear growth velocity (HAZ increment/month) [ Time Frame: monthly from inclusion at 0 months to 17 months of age ]
    To calculate HAZ score the 2006 WHO growth reference will be used

  • Ponderal growth velocity (WHZ increment/month) [ Time Frame: monthly from inclusion at 0 months to 17 months of age ]
    To calculate WHZ score the 2006 WHO growth reference will be used

  • Weight gain (weight increment/month) [ Time Frame: monthly from inclusion at 0 months to 17 months of age ]
  • Mid-upper arm circumference gain (MUAC increment/month) [ Time Frame: monthly from inclusion at 0 months to 17 moths of age ]
  • Infant morbidity (acute respiratory infections, fever, malaria (RDT), vomiting, diarrhea) [ Time Frame: monthly from inclusion at 0 months to 17 moths of age ]
    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) [ Time Frame: monthly from inclusion at 0 months to 17 months of age ]

Estimated Enrollment: 2400
Study Start Date: October 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PROMIS intervention
  • 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)
Dietary Supplement: LNS
A monthly dose of LNS (31 sachets of 20g) will be distributed to mothers attending well-baby visits and participating in small group counseling
Other Name: Lipid-based nutrient supplement (LNS)
Behavioral: Child's health and nutrition topics

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.

Behavioral: National policy well-baby visits
Active Comparator: control
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.
Behavioral: National policy well-baby visits

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.

  Eligibility

Ages Eligible for Study:   up to 17 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  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: NCT02245152

Locations
Burkina Faso
Gourcy Health District
Gourcy, Région du Nord, Burkina Faso
Sponsors and Collaborators
International Food Policy Research Institute
Helen Keller International
Investigators
Principal Investigator: Marie Ruel, PhD International Food Policy Research Institute
Principal Investigator: Jean-Celestin Somda, MD Helen Keller International
  More Information

Responsible Party: International Food Policy Research Institute
ClinicalTrials.gov Identifier: NCT02245152     History of Changes
Other Study ID Numbers: IFPRI-2014-001
DFATD ( Other Grant/Funding Number: 52308/5252/0200 )
Study First Received: September 16, 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 June 26, 2017