Complementary FeedingNCT04835662
Engaging Fathers for Improving Dietary Diversity in Kaduna State
A study testing Complementary feeding promotion in people with Complementary Feeding, run by RTI International at 1 site in Nigeria.
Trial summary
The purpose of this study was to evaluate an intervention to engage fathers in supporting the dietary diversity and other complementary feeding practices of their young children. 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?
- Complementary feeding promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,168 participants
- Where
- 1 siteNigeria
- Study dates
- 31 May 2019to 25 Sep 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
Inclusion Criteria: For the surveys, men were eligible to participate in the surveys if they were 18 years of age or older, had a child aged 6 to 23 months, and were living in the same household as the child's mother. Women were eligible to participate if they were aged 18 to 49 years or aged 15 to 17 years and married, had a child aged 6 to 23 months, and were living in the same household as the child's father. For the qualitative component, mothers, fathers, community and religious leaders, and community health extension workers who participated in the intervention were eligible.
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Exclusion Criteria: Refusal to participate or provide consent.
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Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to evaluate an intervention to engage fathers in supporting the dietary diversity and other complementary feeding practices of their young children.
Read the detailed description
This was pre-post study designed to measure changes in complementary feeding practices and document the feasibility and acceptability of an intervention to engage fathers in supporting dietary diversity in Kaduna State, Nigeria. This study was conducted as part of the Alive \& Thrive Nigeria program, implemented by FHI 360 and partners. RTI led the design and implementation of the study, with Datametrics Associates Ltd. serving as the data collection partner in Nigeria. The study was carried out in 6 wards (2 urban, 4 rural) of Igabi local government area in Kaduna State. We collected survey data cross-sectionally from 495 cohabiting mothers and fathers of children 6-23 months at baseline and endline. Participants were randomly sampled within 99 clusters selected proportional to population size. The purpose of the surveys was to obtain data on children's complementary feeding, changes in fathers' and mothers' knowledge and attitudes related to complementary feeding, and fathers' support for complementary feeding, and to measure participants' exposure to the intervention components. To measure feasibility and acceptability of the intervention, we conducted 24 in-depth interviews at the end of the intervention with community and religious leaders and Community Health Extension Workers who were involved in implementing the intervention. In addition, we conducted separate focus group discussions with mothers and fathers (8 groups each) at the end of the intervention to learn about changes in social norms related to fathers' engagement in complementary feeding and their experiences with participating in the intervention.
- Conditions
- Complementary Feeding
- Being tested
- Complementary feeding promotion
- Keywords
- Minimum dietary diversity, Minimum meal frequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complementary feeding promotionBehavioural
The intervention engaged fathers through community meetings, religious services, and mobile phone text and voice messages. Mothers received home visits from community health extension workers (CHEWs), which fathers also could attend. Social behavior change communication materials included TV and radio messages, sermon guides, counseling cards, pamphlets, posters, and feeding bowls.
| Study group | Role | What they receive |
|---|---|---|
| Complementary feeding promotion | Other | Intervention Receives: Behavioral: Complementary feeding promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum dietary diversity
The proportion of children 6-23 months who consumed at least 4 food groups on the previous day (World Health Organization indicator definition)
Measured: 24 hours
Secondary outcomes (3)
Minimum feeding frequency
The proportion of children 6-23 months who consumed minimum number of meals by age group and breastfeeding status (WHO indicator definition)
Measured: 24 hours
Minimum acceptable diet
Proportion of children 6-23 months with both minimum dietary diversity and minimum meal frequency (WHO indicator definition)
Measured: 24 hours
Consumption of specific food group
Proportion of children 6-23 months who consumed each of the 7 food groups that make up the dietary diversity indicator
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start31 May 2019
- Primary completion25 Sep 2020
- Study completion25 Sep 2020
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,168 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- FHI 360
- Responsible party
- Sponsor
- Investigators
- Valerie Flax, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835662
- Sponsor's protocol ID
- 20575
- Status last verified
- Feb 2021
- First submitted
- 6 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be open
Publications
Allotey D, Flax VL, Ipadeola AF, Kwasu S, Adair LS, Valle CG, Bose S, Martin SL. Fathers' Complementary Feeding Support Strengthens the Association Between Mothers' Decision-Making Autonomy and Optimal Complementary Feeding in Nigeria. Curr Dev Nutr. 2022 Jun 2;6(7):nzac098. doi: 10.1093/cdn/nzac098. eCollection 2022 Jul.
PubMed 35854939Flax VL, Ipadeola A, Schnefke CH, Kwasu S, Mikail AA, Bose S, Brower AO, Edwards S. Complementary Feeding Social and Behavior Change Communication for Fathers and Mothers Improves Children's Consumption of Fish and Eggs and Minimum Meal Frequency in Kaduna State, Nigeria. Curr Dev Nutr. 2022 Apr 8;6(5):nzac075. doi: 10.1093/cdn/nzac075. eCollection 2022 May.
PubMed 35669047
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Fathers for Improving Dietary Diversity in Kaduna State
- ClinicalTrials.gov ID
- NCT04835662
- Acronym / sponsor ID
- 20575
- Conditions
- Complementary Feeding
- Keywords
- Minimum dietary diversity, Minimum meal frequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,168 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- FHI 360
- Study start
- 31 May 2019 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 8 Apr 2021 (actual)
- 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.
The purpose of this study was to evaluate an intervention to engage fathers in supporting the dietary diversity and other complementary feeding practices of their young children.
Detailed description
This was pre-post study designed to measure changes in complementary feeding practices and document the feasibility and acceptability of an intervention to engage fathers in supporting dietary diversity in Kaduna State, Nigeria. This study was conducted as part of the Alive \& Thrive Nigeria program, implemented by FHI 360 and partners. RTI led the design and implementation of the study, with Datametrics Associates Ltd. serving as the data collection partner in Nigeria. The study was carried out in 6 wards (2 urban, 4 rural) of Igabi local government area in Kaduna State. We collected survey data cross-sectionally from 495 cohabiting mothers and fathers of children 6-23 months at baseline and endline. Participants were randomly sampled within 99 clusters selected proportional to population size. The purpose of the surveys was to obtain data on children's complementary feeding, changes in fathers' and mothers' knowledge and attitudes related to complementary feeding, and fathers' support for complementary feeding, and to measure participants' exposure to the intervention components. To measure feasibility and acceptability of the intervention, we conducted 24 in-depth interviews at the end of the intervention with community and religious leaders and Community Health Extension Workers who were involved in implementing the intervention. In addition, we conducted separate focus group discussions with mothers and fathers (8 groups each) at the end of the intervention to learn about changes in social norms related to fathers' engagement in complementary feeding and their experiences with participating in the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complementary feeding promotion | Other | Behavioral: Complementary feeding promotionIntervention |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Complementary feeding promotionThe intervention engaged fathers through community meetings, religious services, and mobile phone text and voice messages. Mothers received home visits from community health extension workers (CHEWs), which fathers also could attend. Social behavior change communication materials included TV and radio messages, sermon guides, counseling cards, pamphlets, posters, and feeding bowls. | Behavioural | Complementary feeding promotion |
Primary outcome
Minimum dietary diversity
Time frame: 24 hours
The proportion of children 6-23 months who consumed at least 4 food groups on the previous day (World Health Organization indicator definition)
3 secondary outcomes
Minimum feeding frequency
Time frame: 24 hours
Minimum acceptable diet
Time frame: 24 hours
Consumption of specific food group
Time frame: 24 hours
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 8 Apr 2021.
- Derived from this study: PubMed 35854939Allotey D, Flax VL, Ipadeola AF, Kwasu S, Adair LS, Valle CG, Bose S, Martin SL. Fathers' Complementary Feeding Support Strengthens the Association Between Mothers' Decision-Making Autonomy and Optimal Complementary Feeding in Nigeria. Curr Dev Nutr. 2022 Jun 2;6(7):nzac098. doi: 10.1093/cdn/nzac098. eCollection 2022 Jul.
- Derived from this study: PubMed 35669047Flax VL, Ipadeola A, Schnefke CH, Kwasu S, Mikail AA, Bose S, Brower AO, Edwards S. Complementary Feeding Social and Behavior Change Communication for Fathers and Mothers Improves Children's Consumption of Fish and Eggs and Minimum Meal Frequency in Kaduna State, Nigeria. Curr Dev Nutr. 2022 Apr 8;6(5):nzac075. doi: 10.1093/cdn/nzac075. eCollection 2022 May.
- Individual participant dataSharing planned: Yes. The data will be open
Related trials for Complementary Feeding
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Feasibility Studies, Microbiome Composition
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GDM
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The Relationship Between Maternal Perinatal Depression and Feeding Behavior Among Primiparas
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complementary feeding promotion in people with Complementary Feeding, run by RTI International at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Apr 2021. 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 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?
Minimum dietary diversity (time frame: 24 hours). 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 NCT04835662, 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 8 Apr 2021.