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StuntingHFP MSNPNCT04185597

Bangladesh MSNP: Agricultural/Livelihood Mixed Methods Study

A study testing HFP Intervention: Delivered by Community Farmers and HFP Intervention: Delivered by agricultural Retailers in people with Stunting and Undernutrition, run by FHI 360 at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Stunting, Undernutrition
What is being tested?
HFP Intervention: Delivered by Community Farmers and HFP Intervention: Delivered by agricultural Retailers
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,067 participants
Where
1 siteBangladesh
Study dates
7 Jul 2018to 28 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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 or poor household, which is defined in Barishal as less than BDT 2056/month on household expenditures or in Khulna as less than BDT 2019/month on household expenditures
  • Note: study inclusion criteria is different from intervention enrollee criteria

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site
  • FHI 360

    Dhaka

Other trials in Bangladesh

About this study

Official title: Bangladesh Multi-Sectoral Nutrition Project: Agricultural/Livelihood 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. In particular, positive correlations between household production and consumption of nutritious food have been widely documented by development organizations in Bangladesh. However, information on how to optimize the delivery of household food production programs is needed.

Read more

The primary objective of this study is to compare the effectiveness of current standard practice with two multisectoral intervention packages focused on homestead food production:

  1. Homestead food production (HFP) supported by community farmers, Social and Behavior Change Communication (SBCC), strengthened health services, and referrals to health and other services
  2. HFP supported by retailers, SBCC, strengthened health services, and referrals to health and other services

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, report reviews and process documentation will be used to assess intervention strengths, weakness, and cost effectiveness.

Read the detailed description

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 to be studied by the Project focuses on integrated agricultural and livelihood activities, known as homestead food production (HFP). This protocol describes a cluster randomized controlled trial (cRCT) to compare two different HFP interventions to the current standard of practice. The two interventions:

  1. Homestead food production (HFP) supported by community farmers, Social and Behavior Change Communication (SBCC), strengthened health services, and referrals to health and other services
  2. HFP supported by retailers, SBCC, strengthened health services, and referrals to health and other services

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 45 unions in Khulna and Barishal Divisions of Bangladesh will be randomly allocated to one of the three study arms: Control (Current Practice), HFP intervention through community farmers (plus SBCC and strengthened health services), or HFP intervention through retailers (plus SBCC and strengthened health services) . 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 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 will be used to compare the study groups; the will be adjustment for clustering at the Union level. A logit link will be used for the primary outcome as it is a dichotomous outcome, while other link functions will be used for other outcomes as appropriate. The comparison of each intervention to the standard of practice is the primary evaluation focus, while the comparison between intervention groups secondary, as the interventions' effects are not expected to be very different from each other. Adjustment for multiple comparisons is not anticipated. The main analysis will use an intention-to-treat (ITT) approach, where study participants' outcomes are analyzed in the study arm the Union was randomized to, regardless of whether or how much they have been exposed to the intervention.

Being tested
HFP Intervention: Delivered by Community Farmers, HFP Intervention: Delivered by agricultural Retailers, Control
Keywords
Bangladesh, Nutrition, Multi-sectoral, Randomized, Household food production
Medical subject headings
Growth Disorders, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HFP Intervention: Delivered by Community FarmersOther

    Homestead food production (HFP) supported by community farmers, Social and Behavior Change Communication (SBCC), strengthened health services, and referrals to health and other services

  • HFP Intervention: Delivered by agricultural RetailersOther

    HFP supported by retailers, SBCC, strengthened health services, and referrals to health and other services

  • ControlOther

    Current Standard of Practice

Study groups in NCT04185597
Study groupRoleWhat they receive
HFP Intervention: Delivery by Community FarmersExperimentalHFP- Delivered by community farmers, supported by the study and linked to eligible households to educate on growing nutritious food and poultry rearing or fish culture Strengthen referrals to health services- Improvements to referral networks will be implemented. Female community nutrition promoters (CNPs) will refer PLW to service delivery points; gradually this will be completed by peer leaders Improving quality of health services- Health-related service providers will be trained and supervised on nutrition best practices SBCC- Primary target is PLW. Delivered using traditional and digital channels. Voice messages will be sent to PLW twice per week. Family members (e.g. husband) will also be encouraged to sign up for different weekly messages. Mothers' groups consisting of ten or fewer will be established. Female CNPs will deliver SBCC during monthly mothers' group meetings, household visits, and in health facilities. CNP's role will later be replaced by peer leaders
Receives: Other: HFP Intervention: Delivered by Community Farmers
HFP Intervention: Delivery by agricultural RetailersExperimentalHFP- Delivered by agricultural Retailers, supported by the study and linked to eligible households to educate on growing nutritious food and either poultry raring or fish culture Strengthen referrals to health services- Improvements to referral networks will be implemented. Female CNPs will refer PLW to service delivery points; gradually this will be completed by peer leaders Improving quality of health services- Health-related service providers will be trained and supervised on nutrition best practices SBCC- Primary target is PLW. Delivered using traditional and digital channels. Voice messages will be sent to PLW twice per week. Family members (e.g. husband) will also be encouraged to sign up for different weekly messages. Mothers' groups consisting of ten or fewer will be established. Female CNPs will deliver SBCC during monthly mothers' group meetings, household visits, and in health facilities. CNP's role will be replaced by peer leaders
Receives: Other: HFP Intervention: Delivered by agricultural Retailers
Standard of PracticeActive comparatorThe 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.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in the proportion of children 6-23 months receiving Minimum Acceptable Diet based on mother/caregiver report

    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

    Measured: This outcome will be assessed not earlier than 22 months after the introduction of the interventions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2019
  2. Study start7 Jul 2018
  3. Primary completion28 Jun 2020
  4. Study completion28 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Single group
Model description
cluster-randomized controlled trial
Masking
None (open label)
Enrolment
4,067 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04185597
Sponsor's protocol ID
1234890-6
Other IDs
14165566
Acronym
HFP MSNP
Status last verified
Feb 2021
First submitted
2 Dec 2019
Last updated
4 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be shared in accordance with USAID's open data policy.

Publications

  • BNNC (2017). Second National Plan of Action on Nutrition. Dhaka. Bangladesh National Nutrition Council (BNNC), 2017

  • Ahmed AU, et al. Which Kinds of Social Safety Net Transfers Work Bets for the Ultra Poor in Bangladesh? Operation and Impacts of the Transfer Modality Research Initiative. Dhaka, IFPRI and WFP, 2016.

  • Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.

    PubMed 23746772
  • BBS (2017). Preliminary Report on Household Income and Expenditure Survey 2016. Dhaka, Bangladesh Bureau of Statistics (BBS), 2017.

  • Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.

    PubMed 18207566
  • FHI 360 (2016). SHIKHA Project Final Report. Dhaka, Bangladesh: FHI 360

  • Food and Nutrition Technical Assistance III Project (FANTA). 2017. Multisectoral Nutrition Programming: FANTA Achievements and Lessons Learned. Washington, DC: FHI 360/ FANTA.

  • GoB. Bangladesh 2nd National Plan of Action (NPAN2) 2016-2025. 2015. Dhaka, Government of Bangladesh.

  • Islam F. National Social Security Strategy (NSSS): Progress of Action Plan preparation. Presented at the Technical Symposium on Nutrition Sensitive Social Protection in Bangladesh, December 2017.

  • MI. (2009). Investing in the future: A united call to action on vitamin and mineral deficiencies: Micronutrient Initiative

  • National Institute of Population Research and Training (NIPORT), Mitra and Associates, and ICF International. 2016. Bangladesh Demographic and Health Survey 2014. Dhaka, Bangladesh, and Rockville, Maryland, USA: NIPORT, Mitra and Associates, and ICF International

  • Save the Children (2012). Nutrition in the First 1000 Days: State of the World's Mothers 2012 Save the Children

  • Essential Nutrition Actions: Improving Maternal, Newborn, Infant and Young Child Health and Nutrition. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK258736/

    PubMed 25473713
  • Arimond M, Daelmans B, Dewey K; Steering Team of the Working Group on Infant and Young Child Feeding Indicators. Indicators for feeding practices in children. Lancet. 2008 Feb 16;371(9612):541-2. doi: 10.1016/S0140-6736(08)60250-0. No abstract available.

    PubMed 18280315
  • WHO, UNICEF, and USAID. (2015). Improving Nutrition Outcomes with Better Water, Sanitation and Hygiene: Practical Solutions for Policies and Programmes. Switzerland: WHO

Questions about this trial

What is this clinical trial studying?

A study testing HFP Intervention: Delivered by Community Farmers and HFP Intervention: Delivered by agricultural Retailers in people with Stunting and Undernutrition, run by FHI 360 at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in the proportion of children 6-23 months receiving Minimum Acceptable Diet based on mother/caregiver report (time frame: This outcome will be assessed not earlier than 22 months after the introduction of the interventions). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04185597, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.

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