Exclusive BreastfeedingA&T-2 EthiopiaNCT02775552
Impact Evaluation of a Multi-Sectoral Community-Based Approach to Improving Infant and Young Child Feeding in Amhara, Ethiopia
A study testing A&T community-based interventions and Mass media in people with Exclusive Breastfeeding and Complementary Feeding, run by International Food Policy Research Institute at 1 site in Ethiopia.
Trial summary
Alive \& Thrive is an initiative that aims to scale up nutrition to save lives, prevent illness, and ensure healthy growth and development through improved infant young child feeding (IYCF) practices. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exclusive Breastfeeding, Complementary Feeding
- What is being tested?
- A&T community-based interventions and Mass media
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,120 participants
- Where
- 1 siteEthiopia
- Study dates
- Mar 2015to Apr 2017
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Gives informed consent
- Being aged from 15 to 49 years (women of reproductive age)
- Has at least one infant less than 24 months old who is currently alive and lives with her
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact Evaluation of Alive & Thrive's Multi-Sectoral Community-Based Approach to Improving Infant and Young Child Feeding in Amhara, Ethiopia
Alive \& Thrive is an initiative that aims to scale up nutrition to save lives, prevent illness, and ensure healthy growth and development through improved infant young child feeding (IYCF) practices. The purpose of this study is to evaluate whether the Alive \& Thrive intervention package, consisting of interpersonal communication, community mobilization activities, and radio campaign, can increase complementary feeding practices (minimum dietary diversity and minimum meal frequency) while sustaining exclusive breastfeeding rate among children less than two years of age. The impact evaluation uses a cluster-randomized design where 20 geographic clusters (woredas/districts) were randomized to two study arms - 10 intervention areas and 10 comparison areas. Repeated cross-sectional baseline and endline surveys will be used to assess program impact.
Read the detailed description
In Amhara, the median duration of exclusive breastfeeding (4.6 months) is the highest among all the other regions in the country, but complementary feeding indicators lag behind (2% minimum dietary diversity and 34% minimum meal frequency). As a result, A\&T's program emphasis will be placed on increasing mothers' knowledge and skills to improve complementary feeding practices without compromising exclusive breastfeeding. Given the short duration of implementation, the goal is to show that it is possible to achieve behavior change related to IYCF through a multi-sector approach. The purpose of this study is to evaluate whether the Alive \& Thrive intervention package, consisting of interpersonal communication, community mobilization activities, and radio campaign, can increase select complementary feeding practices (minimum dietary diversity and minimum meal frequency increased by 10 percentage points) while sustaining exclusive breastfeeding rate among children less than two years of age.
A cluster randomized design with repeated cross-sectional surveys at baseline (2015) and endline (2017) is used to assess impact of the A\&T interventions in three western zones of Amhara, Ethiopia. In the three zones, 20 woredas (districts) were randomly assigned as 10 intervention and 10 comparison/control areas. A\&T intervention areas are expected to receive intensive IYCF social and behavior change communication activities as well as exposure to a region-wide radio campaign. In accordance with program objectives, sample sizes for the household survey were estimated to detect changes in the three main impact indicators - sustained exclusive breastfeeding, improved minimum dietary diversity, and improved minimum meal frequency. The estimated household sample sizes are 400 children 0-5.9 months old for exclusive breastfeeding in the A\&T intervention areas only and 1350 children 6-23.9 months old per study arm for complementary feeding practices, for a total sample size of 3100 children 0-23.9 months of age. Infant feeding practices will be assessed using before- and after- intervention-comparison area group differences between the baseline survey (March-April 2015) and endline survey (March-April 2017). In addition, surveys of frontline workers will help document their awareness and knowledge about IYCF, training, supervision, and delivery of interventions to beneficiary households.
- Conditions
- Exclusive Breastfeeding, Complementary Feeding
- Being tested
- A&T community-based interventions, Mass media
- Keywords
- Child Nutrition, Breastfeeding, Complementary Feeding, Infant and Young Child Feeding, Social and Behavior Change Communication, Ethiopia
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A&T community-based interventionsBehavioural
- Interpersonal communication delivered by health workers and community volunteers at the health post and during home visits to:
- Increase mothers' knowledge about adequate child feeding practices
- Interpersonal communication delivered by agricultural extension workers to:
- Increase fathers' knowledge about nutrition-sensitive agriculture and child feeding
- Community mobilization activities to:
- Raise awareness of child feeding practices among community members, and increase support to mothers (enhanced community conversations)
- Increase mothers' knowledge about preparation of complementary foods (cooking demonstrations)
- Raise awareness of adequate child feeding during fasting among family and community members (church sermons)
- Enhanced training of government health and agricultural extension workers in infant and young child feeding to:
- Improve their ability to provide timely and appropriate information and support to mothers and families
Mass mediaBehavioural
Radio campaign - radio drama series, spots, and jingles
| Study group | Role | What they receive |
|---|---|---|
| A&T intervention areas | Experimental | Not described Receives: Behavioral: A&T community-based interventions; Behavioral: Mass media |
| Comparison areas | Active comparator | (Receive standard government services) Receives: Behavioral: Mass media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive breastfeeding among children aged 0-5.9 months in the intervention areas only
The proportion of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview.
Measured: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Minimum dietary diversity among children aged 6-23.9 months
The proportion of children aged 6-23.9 months months who received foods from 4 or more food groups on the day preceding the interview.
Measured: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Minimum meal frequency of (semi) solid or soft foods among children aged 6-23.9 months
The proportion of children aged 6-23.9 months who received (semi) solid or soft foods the minimum number of times or more on the day preceding the interview.
Measured: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Secondary outcomes (8)
Early initiation of breastfeeding among children aged 0-5.9 months in the intervention areas only and among children aged 6-23.9 months in intervention and comparison areas
The proportion of children aged less than 24 months who were breastfed within 1 hour of birth.
Measured: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Continued breastfeeding at 1 year among children aged 12-15.9 months
The proportion of children aged 12-15.9 months who were breastfed on the day preceding the interview.
Measured: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Timely introduction of (semi) solid or soft foods among children aged 6-8.9 months
The proportion of infants aged 6-8.9 months who received (semi) solid or soft foods on the day preceding the interview.
Measured: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Minimum acceptable diet among children aged 6-23.9 months
The proportion of children aged 6-23.9 months who received a minimum acceptable diet (minimum dietary diversity and minimum meal frequency) on the day preceding the interview.
Measured: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Consumption of iron-rich foods among children aged 6-23.9 months
The proportion of children aged 6-23.9 months who received an iron-rich or iron-fortified food on the day preceding the interview.
Measured: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Mother's accurate knowledge of adequate child feeding practices
Proportion of mothers who report correct knowledge about breastfeeding and complementary feeding practices based on questionnaire
Measured: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Mother's beliefs, self-efficacy, and perceptions of social norms about child feeding during fasting
Proportion of mothers who report positive beliefs, self-efficacy, and perceptions of social norms about feeding animal source foods to children and feeding as often as usual during fasting based on questionnaire
Measured: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Nutritional status of children 6-23 months of age
Prevalence of stunting, underweight and wasting among children 6-23 months
Measured: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startMar 2015
- Primary completionApr 2017
- Study completionApr 2017
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 Exclusive 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,120 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- FHI 360, Save the Children
- Responsible party
- Sponsor
- Investigators
- Purnima Menon, PhD, Principal investigator, International Food Policy Research InstituteSunny S. Kim, PhD, Principal investigator, International Food Policy Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775552
- Sponsor's protocol ID
- 601011
- Acronym
- A&T-2 Ethiopia
- Status last verified
- Feb 2018
- First submitted
- 12 May 2016
- Last updated
- 27 Feb 2018
- 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 31976385Kim SS, Nguyen PH, Yohannes Y, Abebe Y, Tharaney M, Drummond E, Frongillo EA, Ruel MT, Menon P. Behavior Change Interventions Delivered through Interpersonal Communication, Agricultural Activities, Community Mobilization, and Mass Media Increase Complementary Feeding Practices and Reduce Child Stunting in Ethiopia. J Nutr. 2019 Aug 1;149(8):1470-1481. doi: 10.1093/jn/nxz087.
PubMed 31165869
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of Alive & Thrive's Multi-Sectoral Community-Based Approach to Improving Infant and Young Child Feeding in Amhara, Ethiopia
- ClinicalTrials.gov ID
- NCT02775552
- Acronym / sponsor ID
- A&T-2 Ethiopia / 601011
- Conditions
- Exclusive Breastfeeding, Complementary Feeding
- Keywords
- Child Nutrition, Breastfeeding, Complementary Feeding, Infant and Young Child Feeding, Social and Behavior Change Communication, Ethiopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,120 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- FHI 360, Save the Children
- Study start
- Mar 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 17 May 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 is an initiative that aims to scale up nutrition to save lives, prevent illness, and ensure healthy growth and development through improved infant young child feeding (IYCF) practices. The purpose of this study is to evaluate whether the Alive \& Thrive intervention package, consisting of interpersonal communication, community mobilization activities, and radio campaign, can increase complementary feeding practices (minimum dietary diversity and minimum meal frequency) while sustaining exclusive breastfeeding rate among children less than two years of age. The impact evaluation uses a cluster-randomized design where 20 geographic clusters (woredas/districts) were randomized to two study arms - 10 intervention areas and 10 comparison areas. Repeated cross-sectional baseline and endline surveys will be used to assess program impact.
Detailed description
In Amhara, the median duration of exclusive breastfeeding (4.6 months) is the highest among all the other regions in the country, but complementary feeding indicators lag behind (2% minimum dietary diversity and 34% minimum meal frequency). As a result, A\&T's program emphasis will be placed on increasing mothers' knowledge and skills to improve complementary feeding practices without compromising exclusive breastfeeding. Given the short duration of implementation, the goal is to show that it is possible to achieve behavior change related to IYCF through a multi-sector approach. The purpose of this study is to evaluate whether the Alive \& Thrive intervention package, consisting of interpersonal communication, community mobilization activities, and radio campaign, can increase select complementary feeding practices (minimum dietary diversity and minimum meal frequency increased by 10 percentage points) while sustaining exclusive breastfeeding rate among children less than two years of age.
A cluster randomized design with repeated cross-sectional surveys at baseline (2015) and endline (2017) is used to assess impact of the A\&T interventions in three western zones of Amhara, Ethiopia. In the three zones, 20 woredas (districts) were randomly assigned as 10 intervention and 10 comparison/control areas. A\&T intervention areas are expected to receive intensive IYCF social and behavior change communication activities as well as exposure to a region-wide radio campaign. In accordance with program objectives, sample sizes for the household survey were estimated to detect changes in the three main impact indicators - sustained exclusive breastfeeding, improved minimum dietary diversity, and improved minimum meal frequency. The estimated household sample sizes are 400 children 0-5.9 months old for exclusive breastfeeding in the A\&T intervention areas only and 1350 children 6-23.9 months old per study arm for complementary feeding practices, for a total sample size of 3100 children 0-23.9 months of age. Infant feeding practices will be assessed using before- and after- intervention-comparison area group differences between the baseline survey (March-April 2015) and endline survey (March-April 2017). In addition, surveys of frontline workers will help document their awareness and knowledge about IYCF, training, supervision, and delivery of interventions to beneficiary households.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A&T intervention areas | Experimental | Behavioral: A&T community-based interventions, Behavioral: Mass media |
| Comparison areas | Active comparator | Behavioral: Mass media(Receive standard government services) |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Gives informed consent
- Being aged from 15 to 49 years (women of reproductive age)
- Has at least one infant less than 24 months old who is currently alive and lives with her
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 |
|---|---|---|
| A&T community-based interventions1. Interpersonal communication delivered by health workers and community volunteers at the health post and during home visits to: - Increase mothers' knowledge about adequate child feeding practices 2. Interpersonal communication delivered by agricultural extension workers to: - Increase fathers' knowledge about nutrition-sensitive agriculture and child feeding 3. Community mobilization activities to: * Raise awareness of child feeding practices among community members, and increase support to mothers (enhanced community conversations) * Increase mothers' knowledge about preparation of complementary foods (cooking demonstrations) * Raise awareness of adequate child feeding during fasting among family and community members (church sermons) 4. Enhanced training of government health and agricultural extension workers in infant and young child feeding to: * Improve their ability to provide timely and appropriate information and support to mothers and families | Behavioural | A&T intervention areas |
| Mass mediaRadio campaign - radio drama series, spots, and jingles | Behavioural | A&T intervention areas, Comparison areas |
Primary outcome
Exclusive breastfeeding among children aged 0-5.9 months in the intervention areas only
Time frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
The proportion of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview.
Minimum dietary diversity among children aged 6-23.9 months
Time frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
The proportion of children aged 6-23.9 months months who received foods from 4 or more food groups on the day preceding the interview.
Minimum meal frequency of (semi) solid or soft foods among children aged 6-23.9 months
Time frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
The proportion of children aged 6-23.9 months who received (semi) solid or soft foods the minimum number of times or more on the day preceding the interview.
8 secondary outcomes
Early initiation of breastfeeding among children aged 0-5.9 months in the intervention areas only and among children aged 6-23.9 months in intervention and comparison areas
Time frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Continued breastfeeding at 1 year among children aged 12-15.9 months
Time frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Timely introduction of (semi) solid or soft foods among children aged 6-8.9 months
Time frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Minimum acceptable diet among children aged 6-23.9 months
Time frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Consumption of iron-rich foods among children aged 6-23.9 months
Time frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Mother's accurate knowledge of adequate child feeding practices
Time frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Mother's beliefs, self-efficacy, and perceptions of social norms about child feeding during fasting
Time frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
Nutritional status of children 6-23 months of age
Time frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017
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 27 Feb 2018.
- 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 31165869Kim SS, Nguyen PH, Yohannes Y, Abebe Y, Tharaney M, Drummond E, Frongillo EA, Ruel MT, Menon P. Behavior Change Interventions Delivered through Interpersonal Communication, Agricultural Activities, Community Mobilization, and Mass Media Increase Complementary Feeding Practices and Reduce Child Stunting in Ethiopia. J Nutr. 2019 Aug 1;149(8):1470-1481. doi: 10.1093/jn/nxz087.
- Alive \& Thrive initiative websiteLink provided by the sponsor.
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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
Sunny S. Kim, 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 A&T community-based interventions and Mass media in people with Exclusive Breastfeeding and Complementary Feeding, run by International Food Policy Research Institute at 1 site in Ethiopia.
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 3 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 27 Feb 2018. 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 Ethiopia. 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 among children aged 0-5.9 months in the intervention areas only (time frame: 2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017). 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 NCT02775552, 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 27 Feb 2018.