Clinical trial NCT01678716: 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
Overall status: COMPLETED
Phase: NA
Conditions: Child Malnutrition
Breastfeeding
Complementary Feeding
Childhood Anemia
Keywords: Anemia
Breastfeeding
Complementary feeding
Stunting
Wasting
Underweight
Micronutrient powder
Behavior change counseling
Frontline health worker
Lead sponsor: International Food Policy Research Institute
Sponsor class: OTHER
First posted: 2012-09-05
Enrollment: 8800
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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:

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 criteria: Inclusion Criteria:

* Child age \< 60 months

Primary outcomes:
measure: Exclusive breastfeeding (EBF) among children 0-6 months of age
timeFrame: 4 years after baseline
measure: Child anthropometry (height, weight) among children 24-48 months of age
timeFrame: 4 years after baseline
measure: Complementary feeding among children 6-23.9 months of age
timeFrame: 4 years after baseline
measure: Anemia among children 6-23.9 months
timeFrame: 4 years after baseline
Secondary outcomes:
measure: Iron deficiency
timeFrame: 3 years
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Food Policy Research Institute
Study officials:
affiliation: International Food Policy Research Institute
name: Purnima Menon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Food Policy Research Institute
name: Rahul Rawat, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.