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Assessing the Feasibility of Integrating Maternal Nutrition Interventions Into an Existing MNCH Platform in Bangladesh

Primary Purpose

Poor Fetal Growth, Small-for-gestational Age, Premature Birth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Maternal Nutrition Behavior change
Sponsored by
International Food Policy Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poor Fetal Growth

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Recently delivered women with children <6 months of age
  • Pregnant women in second and third trimester and her husbands
  • Frontline health workers in the areas

Exclusion Criteria:

  • Age <18
  • Mental disorders that cannot understand and answer the questions

Sites / Locations

  • International Food Policy Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

A&T- intensive

A&T-non intensive

Arm Description

A&T-intensive arm receive standard MNCH services and intensified maternal nutrition behavior change intervention which focus on improving dietary practices, specifically improved diversity of foods and energy intakes of pregnant women, and improved intake of calcium and iron/folic acid (IFA) supplements.

A&T-non intensive aim only receive MNCH services

Outcomes

Primary Outcome Measures

Use of iron-folic acid supplements
Recall the total number of IFA tablets consumed throughout the last pregnancy
Use of calcium supplements
Recall the total number of calcium tablets consumed throughout the last pregnancy
Dietary diversity during pregnancy
Number of food groups women consumed
Dietary micronutrient intakes
Quantity of micronutrient intakes using 24-hour recall complemented by food weighing.
Coverage of maternal nutrition intervention
The proportion of pregnant and recently delivery women expose to and use of MNCH platform during the last 1 year

Secondary Outcome Measures

Early initiation of breastfeeding
The proportion of newborns aged less than 6 months who were breastfed within 1 hour of birth
Exclusive breastfeeding
The proportion of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview.

Full Information

First Posted
April 1, 2016
Last Updated
September 26, 2017
Sponsor
International Food Policy Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02745249
Brief Title
Assessing the Feasibility of Integrating Maternal Nutrition Interventions Into an Existing MNCH Platform in Bangladesh
Official Title
Assessing the Feasibility of Integrating Maternal Nutrition Interventions Into an Existing Maternal, Newborn, and Child Health Platform in Bangladesh: A Cluster-randomized Operational Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Food Policy Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Inadequate maternal nutrition is likely to undermine the potential impact of infant and young child feeding (IYCF) improvements made in the Alive & Thrive (A&T) first phase because it is linked to poor fetal growth leading to small-for-gestational age and pre-term newborns. These babies do not respond to growth promoting feeding practices as well as normal newborns do. In Phase 2, Alive & Thrive decided to focus on integrating a package of maternal nutrition interventions in a large-scale maternal, newborn and child health program (MNCH). This proposed evaluation aims to assess the feasibility of integrating maternal nutrition interventions into an existing MNCH platform in Bangladesh, using a cluster-randomized evaluation design.
Detailed Description
Inadequate maternal nutrition is likely to undermine the potential impact of IYCF improvements made in the Alive & Thrive (A&T) first phase because it is linked to poor fetal growth leading to small-for-gestational age and pre-term newborns. These babies do not respond to growth promoting feeding practices as well as normal newborns do (WHO Healthy Growth project). In a study of 16,290 singleton infants born in rural Bangladesh from 2004 to 2007, more than 50% were born with low birth-weight. Low birth-weight is a risk factor for neonatal deaths, estimated to be 37 per 1,000 live births in Bangladesh. Factors associated with low birth-weight include young maternal age, poor pre-pregnant nutritional status, short birth intervals, poor maternal dietary intake (quality, quantity, and diversity), and inadequate pregnancy weight gain. Better maternal nutrition will improve maternal and newborn outcomes and facilitate achievement of a continuum of good nutrition. In setting its country program goal for Bangladesh in phase 2, Alive & Thrive decided to focus on demonstrating the feasibility of integrating a package of maternal nutrition interventions in a large-scale MNCH program. Maternal nutrition should receive equal priority as child nutrition and the A&T program of BRAC already has developed an effective strategy though improving IYCF practices. MNCH programs offer the best opportunity for achieving large scale and sustainability. The GOB also promotes mainstreaming of nutrition intervention in health services. Considering the behavior change focus of the Alive & Thrive strategy, efforts will concentrate on improving dietary practices, specifically, improved diversity of foods and energy intakes of pregnant women, and improve the intake of calcium and iron/folic acid supplements. BRAC's supply system will be used to ensure access to calcium and iron/folic acid supplements. The current Government of Bangladesh guidelines of supplementing pregnant women with iron and folic acid and calcium, taken with food (to minimize adverse effects) would be a focus of behavior change interventions. The primary objectives of the proposed evaluation are to answer the following questions using a cluster-randomized evaluation design: Can the coverage and utilization of key maternal nutrition interventions be improved equitably by integrating nutrition-focused BCC and community mobilization into BRAC's rural MNCH program? What factors affect high quality integration of nutrition interventions into a well-established MNCH program platform? Secondary objectives are to examine the following question: • Can an intensive, formative-research based BCC intervention for maternal nutrition improve the quality of diets of pregnant women in rural Bangladesh and facilitate better early breastfeeding practices than via routine MNCH services?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poor Fetal Growth, Small-for-gestational Age, Premature Birth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A&T- intensive
Arm Type
Experimental
Arm Description
A&T-intensive arm receive standard MNCH services and intensified maternal nutrition behavior change intervention which focus on improving dietary practices, specifically improved diversity of foods and energy intakes of pregnant women, and improved intake of calcium and iron/folic acid (IFA) supplements.
Arm Title
A&T-non intensive
Arm Type
No Intervention
Arm Description
A&T-non intensive aim only receive MNCH services
Intervention Type
Behavioral
Intervention Name(s)
Maternal Nutrition Behavior change
Primary Outcome Measure Information:
Title
Use of iron-folic acid supplements
Description
Recall the total number of IFA tablets consumed throughout the last pregnancy
Time Frame
IFA tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016
Title
Use of calcium supplements
Description
Recall the total number of calcium tablets consumed throughout the last pregnancy
Time Frame
Calcium tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016
Title
Dietary diversity during pregnancy
Description
Number of food groups women consumed
Time Frame
Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016
Title
Dietary micronutrient intakes
Description
Quantity of micronutrient intakes using 24-hour recall complemented by food weighing.
Time Frame
Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016
Title
Coverage of maternal nutrition intervention
Description
The proportion of pregnant and recently delivery women expose to and use of MNCH platform during the last 1 year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Early initiation of breastfeeding
Description
The proportion of newborns aged less than 6 months who were breastfed within 1 hour of birth
Time Frame
Infants up to 6 months in a cross-sectional endline survey scheduled for June- August 2016
Title
Exclusive breastfeeding
Description
The proportion of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview.
Time Frame
Infants up to 6 months in a cross-sectional endline survey scheduled for June- August 2016

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Recently delivered women with children <6 months of age Pregnant women in second and third trimester and her husbands Frontline health workers in the areas Exclusion Criteria: Age <18 Mental disorders that cannot understand and answer the questions
Facility Information:
Facility Name
International Food Policy Research Institute
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20006
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32258987
Citation
Nguyen PH, Martin-Prevel Y, Moursi M, Tran LM, Menon P, Ruel MT, Arimond M. Assessing Dietary Diversity in Pregnant Women: Relative Validity of the List-Based and Open Recall Methods. Curr Dev Nutr. 2019 Nov 18;4(1):nzz134. doi: 10.1093/cdn/nzz134. eCollection 2020 Jan.
Results Reference
derived
PubMed Identifier
30649523
Citation
Frongillo EA, Nguyen PH, Sanghvi T, Mahmud Z, Aktar B, Alayon S, Menon P. Nutrition Interventions Integrated into an Existing Maternal, Neonatal, and Child Health Program Reduce Food Insecurity Among Recently Delivered and Pregnant Women in Bangladesh. J Nutr. 2019 Jan 1;149(1):159-166. doi: 10.1093/jn/nxy249.
Results Reference
derived
PubMed Identifier
29931108
Citation
Nguyen PH, Frongillo EA, Sanghvi T, Wable G, Mahmud Z, Tran LM, Aktar B, Afsana K, Alayon S, Ruel MT, Menon P. Engagement of Husbands in a Maternal Nutrition Program Substantially Contributed to Greater Intake of Micronutrient Supplements and Dietary Diversity during Pregnancy: Results of a Cluster-Randomized Program Evaluation in Bangladesh. J Nutr. 2018 Aug 1;148(8):1352-1363. doi: 10.1093/jn/nxy090.
Results Reference
derived
PubMed Identifier
29021370
Citation
Nguyen PH, Kim SS, Sanghvi T, Mahmud Z, Tran LM, Shabnam S, Aktar B, Haque R, Afsana K, Frongillo EA, Ruel MT, Menon P. Integrating Nutrition Interventions into an Existing Maternal, Neonatal, and Child Health Program Increased Maternal Dietary Diversity, Micronutrient Intake, and Exclusive Breastfeeding Practices in Bangladesh: Results of a Cluster-Randomized Program Evaluation. J Nutr. 2017 Dec;147(12):2326-2337. doi: 10.3945/jn.117.257303. Epub 2017 Oct 11.
Results Reference
derived

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Assessing the Feasibility of Integrating Maternal Nutrition Interventions Into an Existing MNCH Platform in Bangladesh

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