Child MalnutritionNCT01678716
Impact of Behavior Change Communications and Market-based Approach to Delivering Micronutrient Powders on Stunting, Infant Feeding Practices and Anemia in Bangladesh
A study testing EHC + BCC, Micronutrient powders and Mass media in people with Child Malnutrition and Breastfeeding, run by International Food Policy Research Institute at 1 site in Bangladesh.
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… Read more about this study
- Who is it for?
- Ages Up to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Malnutrition, Breastfeeding, Complementary Feeding
- What is being tested?
- EHC + BCC, Micronutrient powders and Mass media
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,800 participants
- Where
- 1 siteBangladesh
- Study dates
- Apr 2010to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child age < 60 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Food Policy Research Institute
Dhaka, Dhaka Division, 1212
About this study
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
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.
Read the 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.
- Being tested
- EHC + BCC, Micronutrient powders, Mass media
- Keywords
- Anemia, Breastfeeding, Complementary feeding, Stunting, Wasting, Underweight, Micronutrient powder, Behavior change counseling, Frontline health worker
- Medical subject headings
- Child Nutrition Disorders, Breast Feeding, Anemia, Growth Disorders, Cachexia, Thinness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHC + BCCBehavioural
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
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.
Mass mediaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Micronutrient powders; Behavioral: 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. Receives: Behavioral: EHC + BCC; Behavioral: Mass media |
| EHC + BCC + Micronutrient powders | Experimental | This arm will contain both the behavior change communication and the micronutrient powder sales intervention. Receives: Behavioral: EHC + BCC; Dietary Supplement: Micronutrient powders; Behavioral: Mass media |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 4 years after baseline
Anemia among children 6-23.9 months
Anemia will be measured using Hemocue
Measured: 4 years after baseline
Secondary outcomes (1)
Iron deficiency
Iron deficiency is measured using serum ferritin and serum tranferrin receptor. Assessments are done using capillary blood.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startApr 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Child MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 8,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Purnima Menon, PhD, Principal investigator, International Food Policy Research InstituteRahul Rawat, PhD, Principal investigator, International Food Policy Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678716
- Sponsor's protocol ID
- AED ARTS/IFPRI-S-01
- Other IDs
- IFPRI-107033
- Status last verified
- Feb 2016
- First submitted
- 29 Aug 2012
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31976385Warren 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.
PubMed 31943055Nguyen 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.
PubMed 31346584Frongillo 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.
PubMed 28031374Menon 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.
PubMed 27780198Menon 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.
PubMed 27581575
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01678716
- Acronym / sponsor ID
- AED ARTS/IFPRI-S-01
- Keywords
- Anemia, Breastfeeding, Complementary feeding, Stunting, Wasting, Underweight, Micronutrient powder, Behavior change counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,800 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Essential Health Care (EHC) only | Active comparator | Behavioral: Mass mediaThis 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. |
| EHC + Micronutrient Powders | Experimental | Dietary Supplement: Micronutrient powders, Behavioral: Mass mediaThis arm will be based on the EHC platform but will also include EHC platform health workers promoting and selling the micronutrient powders. |
| EHC + BCC | Experimental | Behavioral: EHC + BCC, Behavioral: Mass mediaThis 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. |
| EHC + BCC + Micronutrient powders | Experimental | Behavioral: EHC + BCC, Dietary Supplement: Micronutrient powders, Behavioral: Mass mediaThis arm will contain both the behavior change communication and the micronutrient powder sales intervention. |
Who may qualify
- Ages
- Up to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child age < 60 months
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EHC + BCCThis 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 | Behavioural | EHC + BCC, EHC + BCC + Micronutrient powders |
| Micronutrient powdersIn 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. | Dietary supplement | EHC + BCC + Micronutrient powders, EHC + Micronutrient Powders |
| Mass mediaA 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. | Behavioural | EHC + BCC, EHC + BCC + Micronutrient powders, EHC + Micronutrient Powders, Essential Health Care (EHC) only |
Primary outcome
Exclusive breastfeeding (EBF) among children 0-6 months of age
Time frame: 4 years after baseline
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
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
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
Anemia will be measured using Hemocue
1 secondary outcome
Iron deficiency
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- Derived from this study: PubMed 31976385Kim 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.
- Derived from this study: PubMed 31943055Warren 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.
- Derived from this study: PubMed 31346584Nguyen 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.
- Derived from this study: PubMed 28031374Frongillo 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.
- Derived from this study: PubMed 27780198Menon 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.
- Derived from this study: PubMed 27581575Menon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Purnima Menon, PhD principal investigator
International Food Policy Research Institute
Rahul Rawat, PhD principal investigator
International Food Policy Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHC + BCC, Micronutrient powders and Mass media in people with Child Malnutrition and Breastfeeding, run by International Food Policy Research Institute at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive breastfeeding (EBF) among children 0-6 months of age (time frame: 4 years after baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01678716, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016.