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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Food Policy Research Institute
ClinicalTrials.gov Identifier:
NCT01678716
First received: August 29, 2012
Last updated: February 29, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention
Child Malnutrition
Breastfeeding
Complementary Feeding
Childhood Anemia
Behavioral: EHC + BCC
Dietary Supplement: Micronutrient powders
Behavioral: Mass media

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

Resource links provided by NLM:


Further study details as provided by International Food Policy Research Institute:

Primary Outcome Measures:
  • Exclusive breastfeeding (EBF) among children 0-6 months of age [ Time Frame: 4 years after baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 years after baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 years after baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 years after baseline ] [ Designated as safety issue: No ]
    Anemia will be measured using Hemocue


Secondary Outcome Measures:
  • Iron deficiency [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Iron deficiency is measured using serum ferritin and serum tranferrin receptor. Assessments are done using capillary blood.


Enrollment: 8800
Study Start Date: April 2010
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Essential Health Care (EHC) only
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
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.
Experimental: EHC + Micronutrient Powders
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 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.
Experimental: EHC + BCC
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 + 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
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.
Experimental: EHC + BCC + Micronutrient powders
This arm will contain both the behavior change communication and the micronutrient powder sales 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.

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:

  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.

  Eligibility

Ages Eligible for Study:   up to 60 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Child age < 60 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678716

Locations
Bangladesh
International Food Policy Research Institute
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Food Policy Research Institute
Investigators
Principal Investigator: Purnima Menon, PhD International Food Policy Research Institute
Principal Investigator: Rahul Rawat, PhD International Food Policy Research Institute
  More Information

Additional Information:
Responsible Party: International Food Policy Research Institute
ClinicalTrials.gov Identifier: NCT01678716     History of Changes
Other Study ID Numbers: AED ARTS/IFPRI-S-01  IFPRI-107033 
Study First Received: August 29, 2012
Last Updated: February 29, 2016
Health Authority: Bangladesh: Ethical Review Committee
United States: Institutional Review Board

Keywords provided by International Food Policy Research Institute:
Anemia
Breastfeeding
Complementary feeding
Stunting
Wasting
Underweight
Micronutrient powder
Behavior change counseling
Frontline health worker

Additional relevant MeSH terms:
Anemia
Malnutrition
Hematologic Diseases
Nutrition Disorders
Micronutrients
Trace Elements
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 03, 2016