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Impact of Behavior Change Communications and Market-based Approach to Delivering Micronutrient Powders on Stunting, Infant Feeding Practices and Anemia in Bangladesh

Primary Purpose

Child Malnutrition, Breastfeeding, Complementary Feeding

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
EHC + BCC
Micronutrient powders
Mass media
Sponsored by
International Food Policy Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Child Malnutrition focused on measuring Anemia, Breastfeeding, Complementary feeding, Stunting, Wasting, Underweight, Micronutrient powder, Behavior change counseling, Frontline health worker

Eligibility Criteria

undefined - 60 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Child age < 60 months

Sites / Locations

  • International Food Policy Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Essential Health Care (EHC) only

EHC + Micronutrient Powders

EHC + BCC

EHC + BCC + Micronutrient powders

Arm Description

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.

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

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.

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

Outcomes

Primary Outcome Measures

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
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.
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.
Anemia among children 6-23.9 months
Anemia will be measured using Hemocue

Secondary Outcome Measures

Iron deficiency
Iron deficiency is measured using serum ferritin and serum tranferrin receptor. Assessments are done using capillary blood.

Full Information

First Posted
August 29, 2012
Last Updated
February 29, 2016
Sponsor
International Food Policy Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01678716
Brief Title
Impact of Behavior Change Communications and Market-based Approach to Delivering Micronutrient Powders on Stunting, Infant Feeding Practices and Anemia in Bangladesh
Official Title
1) Impact Evaluation of Behavior Change Communication and Micronutrient Supplementation Interventions on Infant and Young Child Feeding (IYCF) Practices and on Childhood Stunting and Anaemia 2) Evaluation of the Public Health Impact of a Market-based Approach to Improving Diet Quality of Infants and Young Children Through the Use of Sprinkles in Bangladesh
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (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
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.
Detailed Description
The design uses a repeated cross-sectional design, with multiple age-group samples for multiple outcomes [since each set of outcomes can only be assessed in the relevant age group for the outcome; e.g., exclusive breastfeeding is only assessed in children 0-6 months of age]. These include: For the evaluation of behavior change intervention only: 0-6 months for breastfeeding outcomes 6-23.9 months for complementary feeding outcomes (in the behavior change intervention evaluation) 24-48 months for child anthropometric outcomes (related to the behavior change interventions). for the substudy on behavior change and micronutrient powder interventions combined - 6-23.9 months for anemia and anthropometric outcomes A community-based random sample of children 0-6 months, 6-23.9 months, 24-48 months old was surveyed at baseline (April-June 2010). The original anemia sub-study design had proposed surveying children 6.23.9 months of age for the MNP intervention in April-June 2013 and for the behavior change intervention in April-June 2014. Based on program implementation timelines, the endline survey dates were extended by one year such that the above age groups were then sampled and surveyed in community-based surveys in April-June 2014. Infant feeding practices will be assessed using before-after intervention-comparison area group differences between 2010, and 2013 and 2014. Specifically, breast feeding will be assessed in children 0-6 months of age (sampled separately) and complementary feeding will be assessed in children 6-23.9 months of age (sampled separately). Stunting will be assessed in the sample of children 24-48 months of age using before-after intervention-comparison group differences between 2010 and 2014. In addition, the investigators will evaluate the processes through which the programs roll out using a mix of qualitative and quantitative research methods. Qualitative research methods will help to understand drivers of promotion and sales of MNPs by frontline health workers, as well as household level determinants and dynamics related to enabling purchase and use of the MNP and adhering to behavioral recommendations. Quantitative surveys of frontline health workers will help document their awareness about IYCF, MNPs, training, and sales, while quantitative surveys of the households will help document household level awareness, purchase and use of MNPs and awareness and adherence to IYCF practices for children in the target age range.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Malnutrition, Breastfeeding, Complementary Feeding, Childhood Anemia
Keywords
Anemia, Breastfeeding, Complementary feeding, Stunting, Wasting, Underweight, Micronutrient powder, Behavior change counseling, Frontline health worker

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Essential Health Care (EHC) only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
EHC + Micronutrient Powders
Arm Type
Experimental
Arm Description
This arm will be based on the EHC platform but will also include EHC platform health workers promoting and selling the micronutrient powders.
Arm Title
EHC + BCC
Arm Type
Experimental
Arm Description
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.
Arm Title
EHC + BCC + Micronutrient powders
Arm Type
Experimental
Arm Description
This arm will contain both the behavior change communication and the micronutrient powder sales intervention.
Intervention Type
Behavioral
Intervention Name(s)
EHC + BCC
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Micronutrient powders
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mass media
Intervention Description
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.
Primary Outcome Measure Information:
Title
Exclusive breastfeeding (EBF) among children 0-6 months of age
Description
EBF is among the eight WHO-recommended core indicators for infant and young child feeding and will be measured using recall-based survey measures
Time Frame
4 years after baseline
Title
Child anthropometry (height, weight) among children 24-48 months of age
Description
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.
Time Frame
4 years after baseline
Title
Complementary feeding among children 6-23.9 months of age
Description
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.
Time Frame
4 years after baseline
Title
Anemia among children 6-23.9 months
Description
Anemia will be measured using Hemocue
Time Frame
4 years after baseline
Secondary Outcome Measure Information:
Title
Iron deficiency
Description
Iron deficiency is measured using serum ferritin and serum tranferrin receptor. Assessments are done using capillary blood.
Time Frame
3 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Child age < 60 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Purnima Menon, PhD
Organizational Affiliation
International Food Policy Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rahul Rawat, PhD
Organizational Affiliation
International Food Policy Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Food Policy Research Institute
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh

12. IPD Sharing Statement

Citations:
PubMed Identifier
31976385
Citation
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.
Results Reference
derived
PubMed Identifier
31943055
Citation
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.
Results Reference
derived
PubMed Identifier
31346584
Citation
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.
Results Reference
derived
PubMed Identifier
28031374
Citation
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.
Results Reference
derived
PubMed Identifier
27780198
Citation
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.
Results Reference
derived
PubMed Identifier
27581575
Citation
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.
Results Reference
derived

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Impact of Behavior Change Communications and Market-based Approach to Delivering Micronutrient Powders on Stunting, Infant Feeding Practices and Anemia in Bangladesh

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