Complementary FeedingNCT02975063
Alive & Thrive Nigeria Impact Evaluation
A study testing A&T IYCF intervention in people with Complementary Feeding, run by RTI International at 2 sites in Nigeria.
Trial summary
Investigators will use a cluster-randomized design to evaluate the overall impact of the Alive \& Thrive infant and young child feeding communication strategies in Lagos and Kaduna States, Nigeria. Read more about this study
- Who is it for?
- Ages 15 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Complementary Feeding
- What is being tested?
- A&T IYCF intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,169 participants
- Where
- 2 sitesNigeria
- Study dates
- 19 Jan 2017to 2 Dec 2020
- 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
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For mother's survey:
- Women of reproductive age (15-49 years),
- Must be married if 15-17 years,
- Has a child 0-23 months
- For provider's survey:
- Male or female,
- 18 years or older
- Works in a government or private health facility or works as a community pharmacist, private patent medicine vendor, or traditional birth attendant
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
About this study
Investigators will use a cluster-randomized design to evaluate the overall impact of the Alive \& Thrive infant and young child feeding communication strategies in Lagos and Kaduna States, Nigeria. The impact in each state and in a subset of urban local government areas (LGAs) will also be tested.This is a mixed methods evaluation; the quantitative data will be complemented by qualitative data obtained from different groups targeted by or involved in the program.
Read the detailed description
Adequate nutrition during the first 1,000 days is necessary for children to grow and develop to their full potential. Alive \& Thrive (A\&T) contributes to better nutrition during the first 1,000 days by promoting improved infant and young child feeding (IYCF) practices. A\&T is expanding its efforts to Nigeria and will target Lagos and Kaduna States. In Nigeria, 33% of infants are breastfed within 1 hour of delivery, 60% are given other fluids in the first 3 days of life, and only 17% of children 0-5.9 months are exclusively breastfed. Approximately 60% of children 6 to 23 months achieve the minimum meal frequency for their age and 19% are fed four or more food groups per day. To address these gaps in optimal IYCF practices, A\&T will use an implementation framework for IYCF impact at scale that includes advocacy, interpersonal communication and community mobilization, mass communication, and strategic use of data. The A\&T intervention will be compared to mass media communication on IYCF, which will be provided throughout the two states. LGAs in Lagos and Kaduna will be randomly allocated such that two-thirds receive the A\&T intervention and one-third are assigned to the comparison group. The primary objectives of the evaluation are to measure the impact of the A\&T intervention on IYCF practices among mothers with children 0-23 months of age overall, in each state, and in a subset of urban LGAs. Secondary evaluation objectives are to document: the type, quantity, and timing of the implementation of A\&T program activities; coverage levels A\&T achieves with different program activities; extent to which A\&T increases knowledge and awareness of optimal IYCF practices among women with children 0 to 23 months and health providers; extent to which A\&T improves the capacity of health providers to counsel mothers on IYCF; and extent to which A\&T improves the capacity of stakeholders to implement community-based activities that support optimal IYCF practices.
- Conditions
- Complementary Feeding
- Being tested
- A&T IYCF intervention
- Keywords
- Exclusive breastfeeding
- 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 IYCF interventionBehavioural
(1) Interpersonal communication through frontline workers/volunteers to increase mothers' knowledge and practice of optimal infant and young child feeding (IYCF) behaviors. Interpersonal communication will involve multiple contacts with mothers and an array of IYCF messages; (2) Community mobilization activities to raise awareness of the benefits of optimal IYCF practices among opinion leaders and family members, and increase their support to mother for IYCF; (3) Training of facility and community-based health workers on IYCF to improve their ability to support mothers and provide timely information on IYCF; and (4) Mass media communication on IYCF.
| Study group | Role | What they receive |
|---|---|---|
| A&T IYCF intervention | Experimental | A\&T IYCF intervention is includes comprehensive IYCF counseling which includes intensive activity that aims to deliver one-on-one counseling at home or in a health facility. Receives: Behavioral: A&T IYCF intervention |
| Control | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive breastfeeding on the day preceding the interview.
The proportion of infants 0-5 months who were exclusively breastfed on the previous day.
Measured: 2 years
Secondary outcomes (6)
Exclusive breastfeeding from 0-5 months.
The proportion of children who were exclusively breastfed from 0-5 months.
Measured: 2 years
Breastfeeding within 1 hour of birth.
The proportion of children 0-23 months who were breastfed within 1 hour of birth.
Measured: 2 years
Minimum dietary diversity.
The proportion of children 6-23 months who were fed the minimum number of food groups on the previous day based on the WHO infant and young child feeding guidelines.
Measured: 2 years
Minimum meal frequency.
Description: The proportion of children 6-23 months who were fed the minimum number of meals on the previous day based on the World Health Organization infant and young child feeding guidelines.
Measured: 2 years
Mothers' accurate knowledge of optimal infant and young child feeding practices.
Mothers' accurate knowledge of:
- Optimal timing of breastfeeding initiation
- Optimal duration of exclusive breastfeeding
- Solution to common breastfeeding problems
- Optimal timing to introduce complementary foods
- Optimal dietary diversity and frequency of complementary feeding from 6-23 months
Measured: 2 years
Health providers' knowledge of optimal infant and young child feeding practices.
Providers' accurate knowledge of:
- Optimal timing of breastfeeding initiation
- Optimal duration of exclusive breastfeeding
- Solution to common breastfeeding problems
- Optimal timing to introduce complementary foods
- Optimal dietary diversity and frequency of complementary feeding from 6-23 months
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start19 Jan 2017
- Primary completion2 Dec 2020
- Study completion2 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complementary FeedingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15,169 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- FHI 360, University of North Carolina, Chapel Hill, TNS RMS Nigeria, Ltd.
- Responsible party
- Sponsor
- Investigators
- Valerie Flax, Principal investigator, RTI InternationalMariam Fagbemi, Principal investigator, TNS RMS Nigeria, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975063
- Sponsor's protocol ID
- 08100206
- Status last verified
- Aug 2020
- First submitted
- 19 Oct 2016
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Flax VL, Fagbemi M, Schnefke CH, Kawu AA, Edwards S, Unangst J, Bose S. Impacts of a social and behavior change communication program implemented at scale on infant and young feeding practices in Nigeria: Results of a cluster-randomized evaluation. PLoS One. 2022 Dec 8;17(12):e0277137. doi: 10.1371/journal.pone.0277137. eCollection 2022.
PubMed 36480569
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alive & Thrive Nigeria Impact Evaluation
- ClinicalTrials.gov ID
- NCT02975063
- Acronym / sponsor ID
- 08100206
- Conditions
- Complementary Feeding
- Keywords
- Exclusive breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,169 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- FHI 360, University of North Carolina, Chapel Hill, TNS RMS Nigeria, Ltd.
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 29 Nov 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.
Investigators will use a cluster-randomized design to evaluate the overall impact of the Alive \& Thrive infant and young child feeding communication strategies in Lagos and Kaduna States, Nigeria. The impact in each state and in a subset of urban local government areas (LGAs) will also be tested.This is a mixed methods evaluation; the quantitative data will be complemented by qualitative data obtained from different groups targeted by or involved in the program.
Detailed description
Adequate nutrition during the first 1,000 days is necessary for children to grow and develop to their full potential. Alive \& Thrive (A\&T) contributes to better nutrition during the first 1,000 days by promoting improved infant and young child feeding (IYCF) practices. A\&T is expanding its efforts to Nigeria and will target Lagos and Kaduna States. In Nigeria, 33% of infants are breastfed within 1 hour of delivery, 60% are given other fluids in the first 3 days of life, and only 17% of children 0-5.9 months are exclusively breastfed. Approximately 60% of children 6 to 23 months achieve the minimum meal frequency for their age and 19% are fed four or more food groups per day. To address these gaps in optimal IYCF practices, A\&T will use an implementation framework for IYCF impact at scale that includes advocacy, interpersonal communication and community mobilization, mass communication, and strategic use of data. The A\&T intervention will be compared to mass media communication on IYCF, which will be provided throughout the two states. LGAs in Lagos and Kaduna will be randomly allocated such that two-thirds receive the A\&T intervention and one-third are assigned to the comparison group. The primary objectives of the evaluation are to measure the impact of the A\&T intervention on IYCF practices among mothers with children 0-23 months of age overall, in each state, and in a subset of urban LGAs. Secondary evaluation objectives are to document: the type, quantity, and timing of the implementation of A\&T program activities; coverage levels A\&T achieves with different program activities; extent to which A\&T increases knowledge and awareness of optimal IYCF practices among women with children 0 to 23 months and health providers; extent to which A\&T improves the capacity of health providers to counsel mothers on IYCF; and extent to which A\&T improves the capacity of stakeholders to implement community-based activities that support optimal IYCF practices.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A&T IYCF intervention | Experimental | Behavioral: A&T IYCF interventionA\&T IYCF intervention is includes comprehensive IYCF counseling which includes intensive activity that aims to deliver one-on-one counseling at home or in a health facility. |
| Control | No intervention | –No intervention. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- For mother's survey:
- Women of reproductive age (15-49 years),
- Must be married if 15-17 years,
- Has a child 0-23 months
- For provider's survey:
Key exclusion criteria (1 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 IYCF intervention(1) Interpersonal communication through frontline workers/volunteers to increase mothers' knowledge and practice of optimal infant and young child feeding (IYCF) behaviors. Interpersonal communication will involve multiple contacts with mothers and an array of IYCF messages; (2) Community mobilization activities to raise awareness of the benefits of optimal IYCF practices among opinion leaders and family members, and increase their support to mother for IYCF; (3) Training of facility and community-based health workers on IYCF to improve their ability to support mothers and provide timely information on IYCF; and (4) Mass media communication on IYCF. | Behavioural | A&T IYCF intervention |
Primary outcome
Exclusive breastfeeding on the day preceding the interview.
Time frame: 2 years
The proportion of infants 0-5 months who were exclusively breastfed on the previous day.
6 secondary outcomes
Exclusive breastfeeding from 0-5 months.
Time frame: 2 years
Breastfeeding within 1 hour of birth.
Time frame: 2 years
Minimum dietary diversity.
Time frame: 2 years
Minimum meal frequency.
Time frame: 2 years
Mothers' accurate knowledge of optimal infant and young child feeding practices.
Time frame: 2 years
Health providers' knowledge of optimal infant and young child feeding practices.
Time frame: 2 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 14 Jan 2021.
- Derived from this study: PubMed 36480569Flax VL, Fagbemi M, Schnefke CH, Kawu AA, Edwards S, Unangst J, Bose S. Impacts of a social and behavior change communication program implemented at scale on infant and young feeding practices in Nigeria: Results of a cluster-randomized evaluation. PLoS One. 2022 Dec 8;17(12):e0277137. doi: 10.1371/journal.pone.0277137. eCollection 2022.
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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.
Valerie Flax principal investigator
RTI International
Mariam Fagbemi principal investigator
TNS RMS Nigeria, Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A&T IYCF intervention in people with Complementary Feeding, run by RTI International at 2 sites in Nigeria.
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 8 inclusion and 1 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 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nigeria. 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 on the day preceding the interview. (time frame: 2 years). 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 NCT02975063, which also lists 1 linked publication.
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 14 Jan 2021.