NCT01678716

Brief Summary

This complex evaluation of a large-scale program uses a cluster-randomized design where 20 geographic clusters (subdistricts) were randomized to study two sets of interventions. For the evaluation of behavior change interventions only, the 20 clusters were randomized to 10 intensive and 10 non-intensive interventions areas. For a sub-study to evaluate a market-based model for delivering micronutrient powders (MNP) along with behavior change interventions, there was subsequent randomization to comparison area, MNP-only area, Behavior Change Communication (BCC)-only area and MNP+BCC areas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

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

April 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 5, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 2, 2016

Status Verified

February 1, 2016

Enrollment Period

4.3 years

First QC Date

August 29, 2012

Last Update Submit

February 29, 2016

Conditions

Child MalnutritionBreastfeedingComplementary FeedingChildhood Anemia

Keywords

AnemiaBreastfeedingComplementary feedingStuntingWastingUnderweightMicronutrient powderBehavior change counselingFrontline health worker

Outcome Measures

Primary Outcomes (4)

  • Exclusive breastfeeding (EBF) among children 0-6 months of age

    EBF is among the eight WHO-recommended core indicators for infant and young child feeding and will be measured using recall-based survey measures

    4 years after baseline

  • Child anthropometry (height, weight) among children 24-48 months of age

    Child height and weight will be measured among the repeated cross-sectional of children living in the study villages. These will be converted into z-scores based on the WHO growth reference standards.

    4 years after baseline

  • Complementary feeding among children 6-23.9 months of age

    Complementary feeding indicators that include timely introduction of complementary feeding (infants 6-8 months), dietary diversity, minimum dietary diversity, minimum dietary diversity, are among the eight WHO-recommended core indicators for infant and young child feeding and will be measured using recall-based survey measures in this age group.

    4 years after baseline

  • Anemia among children 6-23.9 months

    Anemia will be measured using Hemocue

    4 years after baseline

Secondary Outcomes (1)

  • Iron deficiency

    3 years

Study Arms (4)

Essential Health Care (EHC) only

ACTIVE COMPARATOR

This arm is the basic comparison arm, which will receive the standard package of health services offered through BRAC's essential health care (basic antenatal care, basic counseling on health and nutrition through health worker home visits. In addition, a nationwide mass media campaign on IYCF practices will ensure exposure to some messages about IYCF behaviors in this arm.

Behavioral: Mass media

EHC + Micronutrient Powders

EXPERIMENTAL

This arm will be based on the EHC platform but will also include EHC platform health workers promoting and selling the micronutrient powders.

Dietary Supplement: Micronutrient powdersBehavioral: Mass media

EHC + BCC

EXPERIMENTAL

This arm will have a behavior chance communications intervention to improve infant and young child feeding practices. The intervention will be delivered primarily by the frontline health workers who will visit mothers in their homes and counsel them on essential IYCF practices.

Behavioral: EHC + BCCBehavioral: Mass media

EHC + BCC + Micronutrient powders

EXPERIMENTAL

This arm will contain both the behavior change communication and the micronutrient powder sales intervention.

Behavioral: EHC + BCCDietary Supplement: Micronutrient powdersBehavioral: Mass media

Interventions

EHC + BCCBEHAVIORAL

This arm includes home visits to mothers with infants and young children. Frontline health workers will counsel and support mothers in relation to breastfeeding and complementary feeding practices

EHC + BCCEHC + BCC + Micronutrient powders
Micronutrient powdersDIETARY_SUPPLEMENT

In this intervention arm, frontline health workers will visit households and promote and sell micronutrient powders to them. The micronutrient powder is sold by the brand name "Pushtikona" in Bangladesh and contains 15 micronutrients including iron, zinc, vitamin A, vitamin C, and others.

EHC + BCC + Micronutrient powdersEHC + Micronutrient Powders
Mass mediaBEHAVIORAL

A nationwide mass media campaign of TV and radio spots on infant and young child feeding practices will be aired in 2011, 2012 and 2013. All intervention arms will be exposed to this campaign.

EHC + BCCEHC + BCC + Micronutrient powdersEHC + Micronutrient PowdersEssential Health Care (EHC) only

Eligibility Criteria

AgeUp to 60 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child age \< 60 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Food Policy Research Institute

Dhaka, Dhaka Division, 1212, Bangladesh

Location

Related Publications (6)

  • Kim SS, Nguyen PH, Tran LM, Alayon S, Menon P, Frongillo EA. Different Combinations of Behavior Change Interventions and Frequencies of Interpersonal Contacts Are Associated with Infant and Young Child Feeding Practices in Bangladesh, Ethiopia, and Vietnam. Curr Dev Nutr. 2019 Dec 9;4(2):nzz140. doi: 10.1093/cdn/nzz140. eCollection 2020 Feb.

    PMID: 31976385DERIVED

  • Warren AM, Frongillo EA, Nguyen PH, Menon P. Nutrition Intervention Using Behavioral Change Communication without Additional Material Inputs Increased Expenditures on Key Food Groups in Bangladesh. J Nutr. 2020 May 1;150(5):1284-1290. doi: 10.1093/jn/nxz339.

    PMID: 31943055DERIVED

  • Nguyen PH, Kim SS, Tran LM, Menon P, Frongillo EA. Intervention Design Elements Are Associated with Frontline Health Workers' Performance to Deliver Infant and Young Child Nutrition Services in Bangladesh and Vietnam. Curr Dev Nutr. 2019 Jul 10;3(8):nzz070. doi: 10.1093/cdn/nzz070. eCollection 2019 Aug.

    PMID: 31346584DERIVED

  • Frongillo EA, Nguyen PH, Saha KK, Sanghvi T, Afsana K, Haque R, Baker J, Ruel MT, Rawat R, Menon P. Large-Scale Behavior-Change Initiative for Infant and Young Child Feeding Advanced Language and Motor Development in a Cluster-Randomized Program Evaluation in Bangladesh. J Nutr. 2017 Feb;147(2):256-263. doi: 10.3945/jn.116.240861. Epub 2016 Dec 28.

    PMID: 28031374DERIVED

  • Menon P, Nguyen PH, Saha KK, Khaled A, Kennedy A, Tran LM, Sanghvi T, Hajeebhoy N, Baker J, Alayon S, Afsana K, Haque R, Frongillo EA, Ruel MT, Rawat R. Impacts on Breastfeeding Practices of At-Scale Strategies That Combine Intensive Interpersonal Counseling, Mass Media, and Community Mobilization: Results of Cluster-Randomized Program Evaluations in Bangladesh and Viet Nam. PLoS Med. 2016 Oct 25;13(10):e1002159. doi: 10.1371/journal.pmed.1002159. eCollection 2016 Oct.

    PMID: 27780198DERIVED

  • Menon P, Nguyen PH, Saha KK, Khaled A, Sanghvi T, Baker J, Afsana K, Haque R, Frongillo EA, Ruel MT, Rawat R. Combining Intensive Counseling by Frontline Workers with a Nationwide Mass Media Campaign Has Large Differential Impacts on Complementary Feeding Practices but Not on Child Growth: Results of a Cluster-Randomized Program Evaluation in Bangladesh. J Nutr. 2016 Oct;146(10):2075-2084. doi: 10.3945/jn.116.232314. Epub 2016 Aug 31.

    PMID: 27581575DERIVED

MeSH Terms

Conditions

Child Nutrition DisordersBreast FeedingAnemiaGrowth DisordersCachexiaThinness

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesFeeding BehaviorBehaviorHematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightSigns and Symptoms

Study Officials

  • Purnima Menon, PhD

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR

  • Rahul Rawat, PhD

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 29, 2012

First Posted

September 5, 2012

Study Start

April 1, 2010

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

March 2, 2016

Record last verified: 2016-02

Locations

BA(1)