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.
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.
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:
- 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 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:
- 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 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.
- Conditions
- Stunting, Undernutrition
- 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 group | Role | What they receive |
|---|---|---|
| HFP Intervention: Delivery by Community Farmers | Experimental | HFP- 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 Retailers | Experimental | HFP- 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 Practice | Active comparator | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted4 Dec 2019
- Study start7 Jul 2018
- Primary completion28 Jun 2020
- Study completion28 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for StuntingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Theresa Hoke, PhD, Principal investigator, FHI 360Taufique Jorder, DrPH, Principal investigator, FHI 360
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 23746772BBS (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 18207566FHI 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 25473713Arimond 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 18280315WHO, UNICEF, and USAID. (2015). Improving Nutrition Outcomes with Better Water, Sanitation and Hygiene: Practical Solutions for Policies and Programmes. Switzerland: WHO
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bangladesh Multi-Sectoral Nutrition Project: Agricultural/Livelihood Mixed Methods Study
- ClinicalTrials.gov ID
- NCT04185597
- Acronym / sponsor ID
- HFP MSNP / 1234890-6
- Conditions
- Stunting, Undernutrition
- Keywords
- Bangladesh, Nutrition, Multi-sectoral, Randomized, Household food production
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,067 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- 7 Jul 2018 (actual)
- Primary completion
- 28 Jun 2020 (actual)
- Study completion
- 28 Jun 2020 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 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.
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:
- 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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- cluster-randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| HFP Intervention: Delivery by Community Farmers | Experimental | Other: HFP Intervention: Delivered by Community FarmersHFP- 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 |
| HFP Intervention: Delivery by agricultural Retailers | Experimental | Other: HFP Intervention: Delivered by agricultural RetailersHFP- 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 |
| Standard of Practice | Active comparator | Other: ControlThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFP Intervention: Delivered by Community FarmersHomestead food production (HFP) supported by community farmers, Social and Behavior Change Communication (SBCC), strengthened health services, and referrals to health and other services | Other | HFP Intervention: Delivery by Community Farmers |
| HFP Intervention: Delivered by agricultural RetailersHFP supported by retailers, SBCC, strengthened health services, and referrals to health and other services | Other | HFP Intervention: Delivery by agricultural Retailers |
| ControlCurrent Standard of Practice | Other | Standard of Practice |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- BackgroundBNNC (2017). Second National Plan of Action on Nutrition. Dhaka. Bangladesh National Nutrition Council (BNNC), 2017
- BackgroundAhmed 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.
- Background: PubMed 23746772Black 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.
- BackgroundBBS (2017). Preliminary Report on Household Income and Expenditure Survey 2016. Dhaka, Bangladesh Bureau of Statistics (BBS), 2017.
- Background: PubMed 18207566Black 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.
- BackgroundFHI 360 (2016). SHIKHA Project Final Report. Dhaka, Bangladesh: FHI 360
- BackgroundFood and Nutrition Technical Assistance III Project (FANTA). 2017. Multisectoral Nutrition Programming: FANTA Achievements and Lessons Learned. Washington, DC: FHI 360/ FANTA.
- BackgroundGoB. Bangladesh 2nd National Plan of Action (NPAN2) 2016-2025. 2015. Dhaka, Government of Bangladesh.
- BackgroundIslam 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.
- BackgroundMI. (2009). Investing in the future: A united call to action on vitamin and mineral deficiencies: Micronutrient Initiative
- BackgroundNational 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
- BackgroundSave the Children (2012). Nutrition in the First 1000 Days: State of the World's Mothers 2012 Save the Children
- Individual participant dataSharing planned: Yes. De-identified data will be shared in accordance with USAID's open data policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa Hoke, PhD principal investigator
FHI 360
Taufique Jorder, DrPH principal investigator
FHI 360
1 site in 1 country: see every site and its status.
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.