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Bangladesh MSNP: Social Protection Mixed Methods Study

2 février 2021 mis à jour par: FHI 360

Bangladesh Multisectoral Nutrition Project: Social Protection Mixed Methods Study

Despite progress in reducing high levels of undernutrition in Bangladesh, gaps in progress persist. They are particularly acute between rural and urban areas, and between the lowest wealth quintile and highest. According to the 2016 Bangladesh DHS report, 38% of rural children under five were stunted compared to 31% of urban children. Forty-nine percent of children in the lowest wealth quintile were stunted compared to 19% in the highest.

To address these discrepancies and lower the overall level of stunting, research is being conducted to assist the government of Bangladesh (GoB) in determining the most effective ways to reduce levels of stunting. The primary objective of this research is to compare the effectiveness of two multisectoral nutrition intervention packages--one with and without a conditional cash transfer (CCT) component--to the current standard of practice. A cluster-randomized controlled trial using mixed methods will be used to evaluate effectiveness. The two intervention arms are as follows;

  • Strengthened: Referrals to health services, strengthened health services, and enhanced social and behavior change communication (SBCC)
  • Strengthened + CCT: Referrals to health services, strengthened health services, enhanced SBCC and cash transfers conditional on a mother attending antenatal care (ANC) and monthly nutrition education SBCC group sessions.

The study's primary outcome is the percentage of children 6-23 months old receiving a minimum acceptable diet (MAD), as a proximate determinant for stunting. MAD is defined as the proportion of children 6-23 months old who receive both the minimum feeding frequency and minimum dietary diversity for their age group and breastfeeding status. It will be assessed based on the mother/caregiver report. Secondary outcomes include assessing the knowledge, attitudes, and practices around breastfeeding, complementary feeding, water sanitation and hygiene, health services and gender norms. Quantitative surveys, in depth interviews, focus group discussions, and detailed program monitoring data will be used to assess intervention strengths, weakness, and cost effectiveness.

Aperçu de l'étude

Description détaillée

According to the 2014 Bangladesh Demographic and Health Survey (BDHS), 36% of children under the age of five were stunted, 14% were wasted and 33% were underweight. These results reflect positive trends in stunting and underweight since 2004, though the rate of decline in undernutrition slowed from 2011 to 2014. And, despite positive trends, there remain gaps in key indicators between rural and urban areas and between those in the highest and lowest wealth quintiles. For instance, according to the BDHS, 38% of rural children under five were stunted compared to 31% of urban children. The wealth discrepancies are even greater; 49% of children under five in the lowest wealth quintile were stunted compared to 19% in the highest quintile.

In 2017, the GoB approved the second National Plan of Action for Nutrition (NPAN 2) 2016-2025. The plan aims to improve nutrition and eliminate malnutrition, with a focus on children, adolescent girls, and pregnant and lactating women. Specific targets of NPAN 2 include reducing stunting to 25% among children under 5; reducing wasting to less than 8% and reducing underweight to less than 15%. A significant acceleration in the annual rate of reduction to 3.3% needs to occur in order to achieve the ambitious Targets by 2025. This acceleration requires high-level political commitment, a strong policy framework, effective coordinating mechanisms, adequate resourcing, strong involvement of local civil society groups, and high impact, cost-effective, multisectoral nutrition interventions.

In 2017, USAID awarded FHI 360 the Strengthening Multisectoral Nutrition Programming through Implementation Science Activity (hereafter referred to as "the Project") to test and refine multisectoral nutrition approaches in high stunting areas of Bangladesh. Under the Project, research is being conducted to assess the effect of different multisectoral nutrition intervention packages aimed at improving nutrition outcomes that are known to contribute to overall healthy nutritional status of children under two in Bangladesh. One of the intervention packages studied by the Project focuses on conditional cash transfers (CCT) for social protection. The primary objective of this study is to compare the effectiveness of the current standard of practice with two multisectoral intervention packages--one with and without a CCT intervention. The two intervention arms are as follows:

  • Strengthened: Referrals to health services, strengthened health services, and enhanced social and behavior change communication (SBCC)
  • Strengthened + CCT: Referrals to health services, strengthened health services, enhanced SBCC and cash transfers conditional on a mother attending antenatal care (ANC) and monthly nutrition education SBCC group sessions.

A cluster-randomized, controlled trial (cRCT) design will be used to evaluate effectiveness. The interventions will be delivered at the level of the union, which is a geo-political unit with an average population of 25,000 people. A total of 60 unions in Khulna and Barishal Divisions of Bangladesh will be randomly allocated to one of the three study arms: Control (Current Practice), Strengthened Intervention, or Strengthened + CCT Intervention. Outcome data will be collected through face-to-face interviews using structured questionnaires with independently selected random samples of mothers/caregivers of children ages 6 to 23 months at baseline (pre-intervention) and again at endline. At both timepoints, participants will be chosen from a sub-sample of the general population who meet the eligibility criteria. Baseline data will be conducted prior to initiation of study activities. Endline data collection will be conducted after two years.

A process evaluation will be completed between baseline and endline to understand how well the interventions were implemented, their costs, and ways they may be improved.

The final evaluation analysis of the cRCT to be done at endline, and will focus on comparing the effect of the intervention on the study outcomes. The study's primary outcome is the percentage of children 6-23 months old receiving a minimum acceptable diet (MAD), as a proximate determinant for stunting. MAD is defined as the proportion of children 6-23 months old who receive both the minimum feeding frequency and minimum dietary diversity for their age group and breastfeeding status. It will be assessed based on the mother/caregiver report. Secondary outcomes include assessing the knowledge, attitudes, and practices around breastfeeding, complementary feeding, water sanitation and hygiene, health services and gender norms.

It is anticipated an analysis of covariance (ANCOVA) approach will be used for a post-only comparison of study arms with possible adjustment for baseline levels in an aggregate manner (note: aggregation for baseline adjustment will be needed given the independent samples selected at each time point). Generalized mixed models to compare the study groups and adjust for clustering at the union level will be used. A logit link will be used for the primary outcome (i.e., minimum acceptable diet) as it is a dichotomous outcome, while other link functions will be used for other outcomes as appropriate. It is hypothesized that the intervention arm with the enhanced SBCC will be superior to standard practice. It is further hypothesized that adding CCT along with the enhanced SBCC will produce an even greater effect. These pairwise comparisons will be tested using the model parameter estimates.

Type d'étude

Interventionnel

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • mother/caregiver of child 6-23 months of age
  • Child 6-23 months is mothers 1st or second (living) child
  • resides in an extreme poor household, which is defined in Barishal as less than BDT 1778/month on household expenditures or in Khulna as less than BDT 1677/month on household expenditures

Note: study inclusion criteria is different from intervention enrollee criteria

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Standard of Practice
Current Standard of Practice
The standard of care includes nutrition and health services provided to all pregnant women and mothers of children under-2 as provided by the GoB and their supporting partners. Services that should be provided include clinic-level infant and young child feeding (IYCF) counseling, growth monitoring and promotion, immunization, iron and folic acid distribution for pregnant women, ANC, safe delivery at community and referral for complications, vitamin-A supplements for postpartum women and children, deworming and management of common childhood illness.
Expérimental: Strengthened Services and Social Behavioral Change (SBCC)
Increase referrals to health services, strengthen health services, and provide enhanced social and behavior change communication (SBCC)

Strengthening referrals to health services- Needed improvements to existing health referral networks will be assessed, identified and implemented. Peer leaders will refer PLW to nearby service delivery points.

Improving quality of health/nutrition services- Health-related service providers will be trained and supervised on nutrition best practices.

SBCC- Primarily target PLW. Delivered using traditional and digital channels. Text/voice messages will be sent to PLW twice per week. Family members (e.g. husband) will also be encouraged to sign up for these messages. Female community nutrition promoters will also be deployed; delivering SBCC during group meetings and in health facilities. Mothers' groups will be established, and will be led by peer leaders, mentored in the delivery of messages on nutrition behavior.

Expérimental: Strengthened Services and SBCC plus Conditional Cash Transfer
Increase referrals to health services, strengthenhealth services, provide enhanced SBCC, as well as cash transfers that are conditional on a mother attending antenatal care (ANC) and monthly nutrition education SBCC group sessions.
Will include all components of the strengthened intervention and participants will receive monthly cash transfers, which is about 25% of monthly consumption expenditure among poor rural households in Bangladesh. Cash transfers will begin when a woman enrolls (at any time during her pregnancy or until 2 months after giving birth). The monthly transfer will continue until a child is 12 months of age, thereby supporting mothers during the critical period of complementary food introduction. The transfer is contingent on having had a minimum of 4 ANC visits and monthly participation in mother's group SBCC sessions.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in the proportion of Children 6-23 months receiving Minimum Acceptable Diet based on mother/caregiver report
Délai: This outcome will be assessed not earlier than 22 months after the introduction of the interventions
Minimum Acceptable Diet (MAD) is defined as children by WHO as the proportion of children 6-23 months of age who receive both the minimum feeding frequency and minimum dietary diversity for their age group and breastfeeding status
This outcome will be assessed not earlier than 22 months after the introduction of the interventions

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Theresa Hoke, PhD, FHI 360
  • Chercheur principal: Taufique Jorder, DrPH, FHI 360

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

26 juillet 2018

Achèvement primaire (Réel)

28 juin 2020

Achèvement de l'étude (Réel)

28 juin 2020

Dates d'inscription aux études

Première soumission

15 octobre 2019

Première soumission répondant aux critères de contrôle qualité

14 novembre 2019

Première publication (Réel)

18 novembre 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 février 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 février 2021

Dernière vérification

1 février 2021

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 1236187
  • 1432173 (Autre identifiant: FHI 360)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified data will be shared in accordance with USAID's open data policy.

Délai de partage IPD

Approximately January 2022.

Critères d'accès au partage IPD

Data will be made available upon request, submitted with a brief concept describing intended use of data.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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