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

Breastfeeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678716
• Other study ID #: AED ARTS/IFPRI-S-01
• Secondary ID: IFPRI-107033
• Status: Completed
• Phase: N/A
• First received: August 29, 2012
• Last updated: February 29, 2016
• Start date: April 2010
• Est. completion date: July 2014

Study information

• Verified date: February 2016
• Source: International Food Policy Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review CommitteeUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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:

1. 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).

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8800
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 60 Months

Eligibility

Inclusion Criteria:

• Child age < 60 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Breastfeeding
• Child Malnutrition
• Childhood Anemia
• Complementary Feeding
• Malnutrition

Intervention

Behavioral:
• EHC + BCC
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

Dietary Supplement:
• Micronutrient powders
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.

Behavioral:
• Mass media
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.

Locations

Country	Name	City	State
Bangladesh	International Food Policy Research Institute	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
International Food Policy Research Institute

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Anemia among children 6-23.9 months	Anemia will be measured using Hemocue	4 years after baseline	No
Secondary	Iron deficiency	Iron deficiency is measured using serum ferritin and serum tranferrin receptor. Assessments are done using capillary blood.	3 years	No

External Links

•   Manuscript describing rationale, approach and evaluation design for main study on impact of behavior change interventions