NCT02745249

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 27, 2017

Status Verified

September 1, 2017

Enrollment Period

1.3 years

First QC Date

April 1, 2016

Last Update Submit

September 26, 2017

Conditions

Outcome Measures

Primary Outcomes (5)

  • Use of iron-folic acid supplements

    Recall the total number of IFA tablets consumed throughout the last pregnancy

    IFA tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016

  • Use of calcium supplements

    Recall the total number of calcium tablets consumed throughout the last pregnancy

    Calcium tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016

  • Dietary diversity during pregnancy

    Number of food groups women consumed

    Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016

  • Dietary micronutrient intakes

    Quantity of micronutrient intakes using 24-hour recall complemented by food weighing.

    Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016

  • 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

    1 year

Secondary Outcomes (2)

  • Early initiation of breastfeeding

    Infants up to 6 months in a cross-sectional endline survey scheduled for June- August 2016

  • Exclusive breastfeeding

    Infants up to 6 months in a cross-sectional endline survey scheduled for June- August 2016

Study Arms (2)

A&T- intensive

EXPERIMENTAL

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.

Behavioral: Maternal Nutrition Behavior change

A&T-non intensive

NO INTERVENTION

A\&T-non intensive aim only receive MNCH services

Interventions

A&T- intensive

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Food Policy Research Institute

Washington D.C., District of Columbia, 20006, United States

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Fetal Growth RetardationPremature Birth

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor Complications

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 20, 2016

Study Start

July 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

September 27, 2017

Record last verified: 2017-09

Locations