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

NCT ID: NCT02245152

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-06
• Study Completion Date: 2017-05-01

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.

Conditions

Child Acute Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

LNS

Intervention Type: DIETARY_SUPPLEMENT

A monthly dose of LNS (31 sachets of 20g) will be distributed to mothers attending well-baby visits and participating in small group counseling

Child's health and nutrition topics

Intervention Type: BEHAVIORAL

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.

National policy well-baby visits

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

National policy well-baby visits

Intervention Type: BEHAVIORAL

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: BEHAVIORAL

National policy well-baby visits

Intervention Type: BEHAVIORAL

Other Intervention Names

Lipid-based nutrient supplement (LNS)

Eligibility Criteria

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

• 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

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

Longitudinal study (n=2,180)

• 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.

• Maximum Eligible Age: 17 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Helen Keller International

OTHER

Sponsor Role: collaborator

International Food Policy Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie Ruel, PhD

Role: PRINCIPAL_INVESTIGATOR

International Food Policy Research Institute

Jean-Celestin Somda, MD

Role: PRINCIPAL_INVESTIGATOR

Helen Keller International

Locations

Gourcy Health District

Gourcy, Région Du Nord, Burkina Faso

Countries

Burkina Faso

References

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.

Reference Type: DERIVED

PMID: 31454347 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28274214 (View on PubMed)

Other Identifiers

DFATD

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IFPRI-2014-001

Identifier Type: -

Identifier Source: org_study_id