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Trial record 3 of 10 for:    strength | ( Map: Bangladesh )

Bangladesh MSNP: Social Protection Mixed Methods Study

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ClinicalTrials.gov Identifier: NCT04166370
Recruitment Status : Recruiting
First Posted : November 18, 2019
Last Update Posted : November 18, 2019
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
FHI 360

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Stunting Undernutrition Other: Control Other: Strengthened (Services and SBCC) Other: Strengthened (Services and SBCC) + CCT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6536 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: cluster-randomized, controlled trial (cRCT)
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Bangladesh Multisectoral Nutrition Project: Social Protection Mixed Methods Study
Actual Study Start Date : September 7, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Active Comparator: Standard of Practice
Current Standard of Practice
Other: Control
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.

Experimental: Strengthened Services and Social Behavioral Change (SBCC)
Increase referrals to health services, strengthen health services, and provide enhanced social and behavior change communication (SBCC)
Other: Strengthened (Services and 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.


Experimental: 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.
Other: Strengthened (Services and SBCC) + CCT
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.




Primary Outcome Measures :
  1. Change 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04166370


Contacts
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Contact: Gwyneth Austin, Mph 504-441-8050 gvance@fhi360.org
Contact: Theresa Hoke, PhD 919-544-7040 thoke@fhi360.org

Locations
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Bangladesh
FHI 360 Recruiting
Dhaka, Bangladesh
Contact: Taufique Jorder, DrPH    880248811336-7    tjorher@fhi360.org   
Contact: Jennifer Crum    8801709391592    jcrum@fhi360.org   
Sponsors and Collaborators
FHI 360
United States Agency for International Development (USAID)
Investigators
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Principal Investigator: Theresa Hoke, PhD FHI 360
Principal Investigator: Taufique Jorder, DrPH FHI 360
Additional Information:
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.
BBS (2017). Preliminary Report on Household Income and Expenditure Survey 2016. Dhaka, Bangladesh Bureau of Statistics (BBS), 2017.
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
WHO (2008). Indicators for assessing infant and young child feeding practices, part 1: definitions
WHO (2013). Essential Nutrition Actions: improving maternal, newborn, infant and young child health and nutrition. Geneva, World Health Organization, 2013.
WHO, UNICEF, and USAID. (2015). Improving Nutrition Outcomes with Better Water, Sanitation and Hygiene: Practical Solutions for Policies and Programmes. Switzerland: WHO

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Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT04166370    
Other Study ID Numbers: 1236187
1432173 ( Other Identifier: FHI 360 )
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared in accordance with USAID's open data policy.
Time Frame: Approximately January 2022.
Access Criteria: Data will be made available upon request, submitted with a brief concept describing intended use of data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by FHI 360:
Bangladesh
Multisectoral
Cash Transfer
Randomized
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders