BreastfeedingNCT02740842
A Follow-up Study on the Sustained Impact of Alive & Thrive Interventions on Infant and Young Child Feeding Practices
A study testing Interpersonal behavioral change communication and Mass media in people with Breastfeeding and Complementary Feeding, run by International Food Policy Research Institute at 1 site in United States.
Trial summary
Alive \& Thrive (A\&T) is a multi-year initiative to improve infant and young child feeding (IYCF) practices. During Phase 1 (A\&T-1, 2009-2014), funded by the Bill \& Melinda Gates Foundation, A\&T aimed to reduce undernutrition and death caused by suboptimal IYCF practices in three countries - Bangladesh, Ethiopia… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breastfeeding, Complementary Feeding
- What is being tested?
- Interpersonal behavioral change communication and Mass media
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Nov 2016
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with children <24 months of age
Who cannot join
- Age <18
- Mental disorders that cannot understand and answer the questions
Trial locations and contacts
1 site in 1 country.
United States1 site
International Food Policy Research Institute
Washington D.C., District of Columbia, 20006
About this study
Official title: A Follow-up Study on the Sustained Impact of Alive & Thrive Behavior Change Communication Interventions on Infant and Young Child Feeding Practices in Bangladesh
Alive \& Thrive (A\&T) is a multi-year initiative to improve infant and young child feeding (IYCF) practices. During Phase 1 (A\&T-1, 2009-2014), funded by the Bill \& Melinda Gates Foundation, A\&T aimed to reduce undernutrition and death caused by suboptimal IYCF practices in three countries - Bangladesh, Ethiopia, and Viet Nam.
In 2014, IFPRI in collaboration with DATA conducted the endline survey in Bangladesh. The overall findings of the evaluation indicate that A\&T's work in Bangladesh is a remarkable success story of scaling up what has been challenging to date in the field of nutrition: complex, high intensity and at-scale behavior change communications interventions.
In 2016, a follow up study will be conducted to determine the sustained impacts on IYCF practices, expansion of operations and promoted practices into new areas, and diffusion of IYCF information, two years after the termination of external project support.
Read the detailed description
Alive \& Thrive (A\&T) is a multi-year initiative to improve infant and young child feeding (IYCF) practices. During Phase 1 (A\&T-1, 2009-2014), funded by the Bill \& Melinda Gates Foundation, A\&T aimed to reduce undernutrition and death caused by suboptimal IYCF practices in three countries - Bangladesh, Ethiopia, and Viet Nam.
A\&T-1 strategies in Bangladesh were designed to support improvements in IYCF in three key ways: 1) improving policy and regulatory environments (advocacy); 2) shaping IYCF demand and practice (community-based interventions); and 3) increasing supply, demand, and use of high quality complementary foods (private sector engagement). In addition, a communications component was integrated into each of these focus areas to support their activities.
In 2014, IFPRI in collaboration with DATA conducted the endline survey. The overall findings of the evaluation indicate that A\&T's work in Bangladesh is a remarkable success story of scaling up what has been challenging to date in the field of nutrition: complex, high intensity and at-scale behavior change communications interventions. This is demonstrated by a series of findings on reach of the interpersonal counseling interventions and the mass media, as well as attributable improvements in several critical indicators. During the intervention period, A\&T facilitated the training of over 75,000 frontline workers and health providers across the country. The program model reached large scale with an estimated 1.7 million mothers of children under 2 years in 50 sub-districts. The mass media intervention operated at a national level and through national television channels. Compared to the 2010 baseline survey, improvements were seen in several key IYCF practices that are attributable to A\&T intensive package of interventions. Specifically, large significant impacts were seen on two key breastfeeding indicators: EBF (DID impact estimates: 36.9 percentage point-pp) and early initiation of BF (DID 19.4 pp). Similarly, large significant impact were seen in minimum dietary diversity (DID 16.3 pp), minimum meal frequency (DID 14.7 pp), minimum acceptable diet (DID 22.0 pp), and consumption of iron rich food (DID 24.6 pp).
In 2016, a follow up study will be conducted to determine the sustained impacts on IYCF practices, expansion of operations and promoted practices into new areas, and diffusion of IYCF information, two years after the termination of external project support. Because achievements related to service delivery and outcomes are intended to be sustained in the intervention areas and even expanded to other areas where BRAC's Essential Health Care program operates, including the comparison areas, this study aims to examine elements in both the original intervention and comparison areas.
This study focuses on the follow-up survey of the BRAC community-based model. The study research questions include:
Sustained impacts
- To what extent are IYCF knowledge and practices sustained in the intervention areas?
- To what extent is exposure to IYCF and nutrition behavior change communications sustained in the intervention areas?
Expanded operations and reach 1) To what extent has exposure to IYCF and nutrition behavior change communications been expanded (i.e. in comparison areas)?
Diffusion of information
- To what extent is IYCF information diffused through social networks or by other sources (i.e. other than BRAC frontline workers)?
- Conditions
- Breastfeeding, Complementary Feeding
- Being tested
- Interpersonal behavioral change communication, Mass media
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal behavioral change communicationBehavioural
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
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 |
|---|---|---|
| Non-intensive group | 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. Receives: Behavioral: Mass media |
| Intensive group | Experimental | Interpersonal behavioral change communication This arm will have a behavior change 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.
In addition, a nationwide mass media campaign on IYCF practices will ensure exposure to some messages about IYCF behaviors in this arm. Receives: Behavioral: Interpersonal behavioral change communication; 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
The proportion of infants less than 6 months who have been exclusively breastfed on the day preceding the interview
Measured: 2 years after endline
Early initiation of breastfeeding
The proportion of newborns aged less than 24 months who were breastfed within 1 hour of birth.
Measured: 2 years after endline
Complementary feeding among children 6-23.9 months of age
Complementary feeding indicators that include timely introduction of complementary foods (infants 6-8 months), dietary diversity (consumed at least 4 food groups), minimum meal frequency, will be measured using questionnaire.
Measured: 2 years after endline
Secondary outcomes (3)
Extension of exposure to IYCF and nutrition behavioral change communication
Proportion of mothers with children <2 years exposed to IYCF and nutrition messages
Measured: 2 years after endline
Diffusion of IYCF information though social network
Number of sources that provide IYCF information or messages
Measured: 2 years after endline
Knowledge of infant and young child feeding
Proportion of mothers report correct knowledge on breastfeeding and complementary feeding based on questionnaire
Measured: 2 years after endline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- FHI 360
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740842
- Sponsor's protocol ID
- IFPRI_1
- Status last verified
- Feb 2017
- First submitted
- 7 Apr 2016
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Nguyen PH, Frongillo EA, Kim SS, Zongrone AA, Jilani A, Tran LM, Sanghvi T, Menon P. Information Diffusion and Social Norms Are Associated with Infant and Young Child Feeding Practices in Bangladesh. J Nutr. 2019 Nov 1;149(11):2034-2045. doi: 10.1093/jn/nxz167.
PubMed 31396621Kim SS, Nguyen PH, Tran LM, Sanghvi T, Mahmud Z, Haque MR, Afsana K, Frongillo EA, Ruel MT, Menon P. Large-Scale Social and Behavior Change Communication Interventions Have Sustained Impacts on Infant and Young Child Feeding Knowledge and Practices: Results of a 2-Year Follow-Up Study in Bangladesh. J Nutr. 2018 Oct 1;148(10):1605-1614. doi: 10.1093/jn/nxy147.
PubMed 30169665
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-up Study on the Sustained Impact of Alive & Thrive Behavior Change Communication Interventions on Infant and Young Child Feeding Practices in Bangladesh
- ClinicalTrials.gov ID
- NCT02740842
- Acronym / sponsor ID
- IFPRI_1
- Conditions
- Breastfeeding, Complementary Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- FHI 360
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 15 Apr 2016 (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.
Alive \& Thrive (A\&T) is a multi-year initiative to improve infant and young child feeding (IYCF) practices. During Phase 1 (A\&T-1, 2009-2014), funded by the Bill \& Melinda Gates Foundation, A\&T aimed to reduce undernutrition and death caused by suboptimal IYCF practices in three countries - Bangladesh, Ethiopia, and Viet Nam.
In 2014, IFPRI in collaboration with DATA conducted the endline survey in Bangladesh. The overall findings of the evaluation indicate that A\&T's work in Bangladesh is a remarkable success story of scaling up what has been challenging to date in the field of nutrition: complex, high intensity and at-scale behavior change communications interventions.
In 2016, a follow up study will be conducted to determine the sustained impacts on IYCF practices, expansion of operations and promoted practices into new areas, and diffusion of IYCF information, two years after the termination of external project support.
Detailed description
Alive \& Thrive (A\&T) is a multi-year initiative to improve infant and young child feeding (IYCF) practices. During Phase 1 (A\&T-1, 2009-2014), funded by the Bill \& Melinda Gates Foundation, A\&T aimed to reduce undernutrition and death caused by suboptimal IYCF practices in three countries - Bangladesh, Ethiopia, and Viet Nam.
A\&T-1 strategies in Bangladesh were designed to support improvements in IYCF in three key ways: 1) improving policy and regulatory environments (advocacy); 2) shaping IYCF demand and practice (community-based interventions); and 3) increasing supply, demand, and use of high quality complementary foods (private sector engagement). In addition, a communications component was integrated into each of these focus areas to support their activities.
In 2014, IFPRI in collaboration with DATA conducted the endline survey. The overall findings of the evaluation indicate that A\&T's work in Bangladesh is a remarkable success story of scaling up what has been challenging to date in the field of nutrition: complex, high intensity and at-scale behavior change communications interventions. This is demonstrated by a series of findings on reach of the interpersonal counseling interventions and the mass media, as well as attributable improvements in several critical indicators. During the intervention period, A\&T facilitated the training of over 75,000 frontline workers and health providers across the country. The program model reached large scale with an estimated 1.7 million mothers of children under 2 years in 50 sub-districts. The mass media intervention operated at a national level and through national television channels. Compared to the 2010 baseline survey, improvements were seen in several key IYCF practices that are attributable to A\&T intensive package of interventions. Specifically, large significant impacts were seen on two key breastfeeding indicators: EBF (DID impact estimates: 36.9 percentage point-pp) and early initiation of BF (DID 19.4 pp). Similarly, large significant impact were seen in minimum dietary diversity (DID 16.3 pp), minimum meal frequency (DID 14.7 pp), minimum acceptable diet (DID 22.0 pp), and consumption of iron rich food (DID 24.6 pp).
In 2016, a follow up study will be conducted to determine the sustained impacts on IYCF practices, expansion of operations and promoted practices into new areas, and diffusion of IYCF information, two years after the termination of external project support. Because achievements related to service delivery and outcomes are intended to be sustained in the intervention areas and even expanded to other areas where BRAC's Essential Health Care program operates, including the comparison areas, this study aims to examine elements in both the original intervention and comparison areas.
This study focuses on the follow-up survey of the BRAC community-based model. The study research questions include:
Sustained impacts
- To what extent are IYCF knowledge and practices sustained in the intervention areas?
- To what extent is exposure to IYCF and nutrition behavior change communications sustained in the intervention areas?
Expanded operations and reach 1) To what extent has exposure to IYCF and nutrition behavior change communications been expanded (i.e. in comparison areas)?
Diffusion of information
- To what extent is IYCF information diffused through social networks or by other sources (i.e. other than BRAC frontline workers)?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-intensive group | Active comparator | Behavioral: Mass mediaEssential 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. |
| Intensive group | Experimental | Behavioral: Interpersonal behavioral change communication, Behavioral: Mass mediaInterpersonal behavioral change communication This arm will have a behavior change 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. In addition, a nationwide mass media campaign on IYCF practices will ensure exposure to some messages about IYCF behaviors in this arm. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with children <24 months of age
Key exclusion criteria (2 listed)
- Age <18
- Mental disorders that cannot understand and answer the questions
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 |
|---|---|---|
| Interpersonal behavioral change communicationThis 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 | Intensive group |
| 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 | Intensive group, Non-intensive group |
Primary outcome
Exclusive breastfeeding (EBF) among children 0-6 months of age
Time frame: 2 years after endline
The proportion of infants less than 6 months who have been exclusively breastfed on the day preceding the interview
Early initiation of breastfeeding
Time frame: 2 years after endline
The proportion of newborns aged less than 24 months who were breastfed within 1 hour of birth.
Complementary feeding among children 6-23.9 months of age
Time frame: 2 years after endline
Complementary feeding indicators that include timely introduction of complementary foods (infants 6-8 months), dietary diversity (consumed at least 4 food groups), minimum meal frequency, will be measured using questionnaire.
3 secondary outcomes
Extension of exposure to IYCF and nutrition behavioral change communication
Time frame: 2 years after endline
Diffusion of IYCF information though social network
Time frame: 2 years after endline
Knowledge of infant and young child feeding
Time frame: 2 years after endline
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 16 Oct 2019.
- Derived from this study: PubMed 31396621Nguyen PH, Frongillo EA, Kim SS, Zongrone AA, Jilani A, Tran LM, Sanghvi T, Menon P. Information Diffusion and Social Norms Are Associated with Infant and Young Child Feeding Practices in Bangladesh. J Nutr. 2019 Nov 1;149(11):2034-2045. doi: 10.1093/jn/nxz167.
- Derived from this study: PubMed 30169665Kim SS, Nguyen PH, Tran LM, Sanghvi T, Mahmud Z, Haque MR, Afsana K, Frongillo EA, Ruel MT, Menon P. Large-Scale Social and Behavior Change Communication Interventions Have Sustained Impacts on Infant and Young Child Feeding Knowledge and Practices: Results of a 2-Year Follow-Up Study in Bangladesh. J Nutr. 2018 Oct 1;148(10):1605-1614. doi: 10.1093/jn/nxy147.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal behavioral change communication and Mass media in people with Breastfeeding and Complementary Feeding, run by International Food Policy Research Institute at 1 site in United States.
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 2 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 16 Oct 2019. 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 United States. 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: 2 years after endline). The study lists 3 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 NCT02740842, which also lists 2 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 16 Oct 2019.