Breastfeeding, ExclusiveLAUNCHNCT05111899
Leading Advancements in the Uptake of Newborn Community Health
A study testing Newborn Health Education in people with Breastfeeding, Exclusive and Immunization; Infection, run by University of Washington at 1 site in Ethiopia.
Trial summary
The primary objective of the study is to determine the impact of a behavior change intervention that partners Orthodox priests with members of the Health Development Army (HDA) and train them to conduct newborn health outreach to increase rates of early initiation of and exclusive breastfeeding through 6 months and… Read more about this study
- Who is it for?
- Ages 14 to 49 years, women only
- Conditions the study is for
- Breastfeeding, Exclusive, Immunization; Infection, Growth; Stunting, Nutritional
- What is being tested?
- Newborn Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteEthiopia
- Study dates
- 11 Jul 2022to 1 Apr 2024
- 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 14 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newborn-mother pairs visited by the study staff (Enrolled women and newborns)
- The following inclusion criteria will be used during recruitment:
- Newborns should be those delivered at least one month after the start of the intervention period
- Newborn-mother pairs should be EOC parishioners
- Newborn's family should have a soul father (a spiritual advisor assigned to the family in the Ethiopian Orthodox tradition)
- Mother must have lived in the study area for at least 6 months
Show all 15Show fewer
- Mothers must give written informed consent for themselves and their newborn
- Formative focus group discussion and key informant interview participants (FGD and KII participants)
- The following inclusion criteria will be used during recruitment:
- Mothers of newborns <6 months old
- Fathers of newborn children <6 months
- Ethiopian Orthodox priests from the North Gondar region
- Healthcare workers from government Health Centers (unit of primary care)
- All participants must have established residency in the region for >6 months
- All participant must give verbal informed consent
Who cannot join
- Newborn-mother pairs visited by the study staff (Enrolled women and newborns)
- The following exclusion criteria will be used during recruitment:
- Newborns with gross developmental abnormalities that would make anthropometric measurements and interpretations difficult
- Newborns identified by the study team as in distress and in need of immediate, emergency care during the enrollment visit
- Newborn whose mother is not a member of an EOC parish
- Newborns whose mothers have died by the time of recruitment
Show all 11Show fewer
- Newborn whose family plans to re-locate away from the study site in less than 6 months
- Newborns who were part of a multiple birth but are not the first born should be excluded
- Formative focus group discussion and key informant interview participants (FGD and KII participants)
- The following exclusion criteria will be used during recruitment:
- Newly established residence in the Woreda (<6 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leading Advancements in the Uptake of Newborn Community Health (LAUNCH)
The primary objective of the study is to determine the impact of a behavior change intervention that partners Orthodox priests with members of the Health Development Army (HDA) and train them to conduct newborn health outreach to increase rates of early initiation of and exclusive breastfeeding through 6 months and vaccination coverage at six months.
Secondary objectives include:
- Determine the impact of the intervention on infant growth at six months, observed and self-reported changes in nutrition and feeding practices of mother and infants, and early identification of newborn illness.
- Design a culturally relevant, scalable intervention for community-based newborn and infant health in Gondar in partnership with local partners, the Federal Ministry of Health, and the Gondar Regional Health Bureau.
Read the detailed description
The study will test a model the leverages existing community networks to improve the health of newborns in Gondar, Ethiopia. The intervention will be implemented at the community level by pairs of trained Ethiopian Orthodox priests and members of the Heath Development Army (HDA). A list of priests serving at the EOC churches in the intervention arm will be obtained through the woreda diocese and their respective churches. All the priests will be contacted through the church leadership and asked to participate in the study intervention. The intervention will be implemented in collaboration with HDA members recruited by HEWs under the health centers in the catchment areas of the intervention churches.
An initial 5 day training will be given to priests and HDA members. The training will focus on newborn health topics including early initiation of and exclusive breastfeeding, maternal nutrition, immunization, childhood illnesses, child health care services, etc. At the end of the training action plans will be prepared by the training organizers, priests, and HDA. Priest will be asked to integrate health messages and education into their routine family visits around the birth of a child in structured intervals as culturally appropriate.
The trained priests and HDA members will be dispatched to their respective communities to begin the intervention. Their primary activities will be identification of near-term pregnant and newly delivered women, providing health education to their families, follow-up visits to enable newborn-mother pairs to access child health care services, and to provide health education at religious and community gatherings. Specifically, pre-planned visits of parishioners' families will be done by the respective priests and the partnering HDA members during the last month of pregnancy, immediately after the delivery of the baby and around the time of baptism for the newborn. These visits will be used to educate pregnant and postpartum women and their families on newborn health topics including initiation of breastfeeding, duration of breastfeeding/ exclusive breastfeeding, vaccination, cord care, and utilization of available newborn health care services. These community based activities will be monitored through regular follow-up visits by the UoG study team and discussions with priests and HDA members.
Newborn-mother pairs will be recruited within the first 10 days after delivery as reported to the study team by Health Extension Workers (HEWs) engaged in the study. Recruitment will start one month following the start of the intervention and all reported newborn-mother pairs who meet the screening criteria will be included in the study until the calculated sample sizes are reached. HEW's routine registers of new deliveries will be used to trace, recruit and screen study participants. Newborn-mother pairs who fulfill an initial screening criteria will be reported to the study team at the University of Gondar (UoG) who will travel to the study site regularly for recruitment of study participants and data collection. Newborn-mother pairs will be reported to the UoG study team both through phone calls made by HEWs and in-person at the time of regular onsite visits by the team.
Newborn-mother pairs will be recruited within the first 10 days after delivery as reported to the study team by Health Extension Workers (HEWs) engaged in the study. Recruitment will start one month following the start of the intervention and all reported newborn-mother pairs who meet the screening criteria will be included in the study until the calculated sample sizes are reached. HEW's routine registers of new deliveries will be used to trace, recruit and screen study participants. Newborn-mother pairs who fulfill an initial screening criteria will be reported to the study team at the University of Gondar (UoG) who will travel to the study site regularly for recruitment of study participants and data collection. Newborn-mother pairs will be reported to the UoG study team both through phone calls made by HEWs and in-person at the time of regular onsite visits by the team.
Eligible newborn-mother pairs will be visited by a member of the study team at their home or at an appointed meeting location in their community to complete the verbal informed consent process. Those pairs who attend church at a parish that received the intervention will be assigned to the intervention arm, and those from the parishes where no intervention was conducted will be assigned to the control arm. Initial baseline data will then be collected and follow-up visit schedules arranged with the study team.
- Being tested
- Newborn Health Education
- Keywords
- Community health worker
- Medical subject headings
- Breast Feeding, Infections, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newborn Health EducationBehavioural
Community influencers will receive training and give community education to women and their families regarding newborn health.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Newborn Health Education |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid-upper arm circumference
Anthropometric Measurement using MUAC tapes
Measured: Up to six months
Proportion of mothers exclusive breastfeeding
Self-reported breastfeeding behavior
Measured: Up to six months
Secondary outcomes (3)
Immunization status
Collected from vaccination cards
Measured: Up to six months
Frequency of acute illness
Self reported
Measured: Up to six months
Frequency of hospitalization status
Self reported
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start11 Jul 2022
- Primary completion22 Aug 2023
- Study completion1 Apr 2024 (estimated)
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 Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Frankel Family Foundation, Stewardship Foundation
- Responsible party
- Principal investigator, Brandon Guthrie, University of Washington
- Investigators
- Brandon Guthrie, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111899
- Sponsor's protocol ID
- STUDY00006942
- Acronym
- LAUNCH
- Status last verified
- Mar 2024
- First submitted
- 26 Jul 2021
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alemie GA, Walson J, Rankin KC, Wild LM, Tesema GA, Belay DG, Hakizimana D, Guthrie BL. Newborn community health advancements among Ethiopian Orthodox Christian women in North Gondar, Ethiopia: community-based randomised trial protocol. BMJ Open. 2024 Sep 13;14(9):e081330. doi: 10.1136/bmjopen-2023-081330.
PubMed 39277203
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leading Advancements in the Uptake of Newborn Community Health (LAUNCH)
- ClinicalTrials.gov ID
- NCT05111899
- Acronym / sponsor ID
- LAUNCH / STUDY00006942
- Keywords
- Community health worker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 316 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Frankel Family Foundation, Stewardship Foundation
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 8 Nov 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 primary objective of the study is to determine the impact of a behavior change intervention that partners Orthodox priests with members of the Health Development Army (HDA) and train them to conduct newborn health outreach to increase rates of early initiation of and exclusive breastfeeding through 6 months and vaccination coverage at six months.
Secondary objectives include:
- Determine the impact of the intervention on infant growth at six months, observed and self-reported changes in nutrition and feeding practices of mother and infants, and early identification of newborn illness.
- Design a culturally relevant, scalable intervention for community-based newborn and infant health in Gondar in partnership with local partners, the Federal Ministry of Health, and the Gondar Regional Health Bureau.
Detailed description
The study will test a model the leverages existing community networks to improve the health of newborns in Gondar, Ethiopia. The intervention will be implemented at the community level by pairs of trained Ethiopian Orthodox priests and members of the Heath Development Army (HDA). A list of priests serving at the EOC churches in the intervention arm will be obtained through the woreda diocese and their respective churches. All the priests will be contacted through the church leadership and asked to participate in the study intervention. The intervention will be implemented in collaboration with HDA members recruited by HEWs under the health centers in the catchment areas of the intervention churches.
An initial 5 day training will be given to priests and HDA members. The training will focus on newborn health topics including early initiation of and exclusive breastfeeding, maternal nutrition, immunization, childhood illnesses, child health care services, etc. At the end of the training action plans will be prepared by the training organizers, priests, and HDA. Priest will be asked to integrate health messages and education into their routine family visits around the birth of a child in structured intervals as culturally appropriate.
The trained priests and HDA members will be dispatched to their respective communities to begin the intervention. Their primary activities will be identification of near-term pregnant and newly delivered women, providing health education to their families, follow-up visits to enable newborn-mother pairs to access child health care services, and to provide health education at religious and community gatherings. Specifically, pre-planned visits of parishioners' families will be done by the respective priests and the partnering HDA members during the last month of pregnancy, immediately after the delivery of the baby and around the time of baptism for the newborn. These visits will be used to educate pregnant and postpartum women and their families on newborn health topics including initiation of breastfeeding, duration of breastfeeding/ exclusive breastfeeding, vaccination, cord care, and utilization of available newborn health care services. These community based activities will be monitored through regular follow-up visits by the UoG study team and discussions with priests and HDA members.
Newborn-mother pairs will be recruited within the first 10 days after delivery as reported to the study team by Health Extension Workers (HEWs) engaged in the study. Recruitment will start one month following the start of the intervention and all reported newborn-mother pairs who meet the screening criteria will be included in the study until the calculated sample sizes are reached. HEW's routine registers of new deliveries will be used to trace, recruit and screen study participants. Newborn-mother pairs who fulfill an initial screening criteria will be reported to the study team at the University of Gondar (UoG) who will travel to the study site regularly for recruitment of study participants and data collection. Newborn-mother pairs will be reported to the UoG study team both through phone calls made by HEWs and in-person at the time of regular onsite visits by the team.
Newborn-mother pairs will be recruited within the first 10 days after delivery as reported to the study team by Health Extension Workers (HEWs) engaged in the study. Recruitment will start one month following the start of the intervention and all reported newborn-mother pairs who meet the screening criteria will be included in the study until the calculated sample sizes are reached. HEW's routine registers of new deliveries will be used to trace, recruit and screen study participants. Newborn-mother pairs who fulfill an initial screening criteria will be reported to the study team at the University of Gondar (UoG) who will travel to the study site regularly for recruitment of study participants and data collection. Newborn-mother pairs will be reported to the UoG study team both through phone calls made by HEWs and in-person at the time of regular onsite visits by the team.
Eligible newborn-mother pairs will be visited by a member of the study team at their home or at an appointed meeting location in their community to complete the verbal informed consent process. Those pairs who attend church at a parish that received the intervention will be assigned to the intervention arm, and those from the parishes where no intervention was conducted will be assigned to the control arm. Initial baseline data will then be collected and follow-up visit schedules arranged with the study team.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Newborn Health Education |
| Control | No intervention | – |
Who may qualify
- Ages
- 14 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- Newborn-mother pairs visited by the study staff (Enrolled women and newborns)
- Newborns should be those delivered at least one month after the start of the intervention period
- Newborn-mother pairs should be EOC parishioners
- Newborn's family should have a soul father (a spiritual advisor assigned to the family in the Ethiopian Orthodox tradition)
- Mother must have lived in the study area for at least 6 months
Key exclusion criteria (11 listed)
- Newborn-mother pairs visited by the study staff (Enrolled women and newborns)
- Newborns with gross developmental abnormalities that would make anthropometric measurements and interpretations difficult
- Newborns identified by the study team as in distress and in need of immediate, emergency care during the enrollment visit
- Newborn whose mother is not a member of an EOC parish
- Newborns whose mothers have died by the time of recruitment
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 |
|---|---|---|
| Newborn Health EducationCommunity influencers will receive training and give community education to women and their families regarding newborn health. | Behavioural | Intervention |
Primary outcome
Mid-upper arm circumference
Time frame: Up to six months
Anthropometric Measurement using MUAC tapes
Proportion of mothers exclusive breastfeeding
Time frame: Up to six months
Self-reported breastfeeding behavior
3 secondary outcomes
Immunization status
Time frame: Up to six months
Frequency of acute illness
Time frame: Up to six months
Frequency of hospitalization status
Time frame: Up to six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Derived from this study: PubMed 39277203Alemie GA, Walson J, Rankin KC, Wild LM, Tesema GA, Belay DG, Hakizimana D, Guthrie BL. Newborn community health advancements among Ethiopian Orthodox Christian women in North Gondar, Ethiopia: community-based randomised trial protocol. BMJ Open. 2024 Sep 13;14(9):e081330. doi: 10.1136/bmjopen-2023-081330.
- Individual participant dataSharing planned: Undecided
Related trials for Breastfeeding, Exclusive
Not yet recruiting
Effect of a Breastfeeding Chatbot on Mothers' Breastfeeding Attitudes, Behaviors, and Self-Efficacy
Breastfeeding, Breastfeeding Attitudes
Not yet recruiting
Healthy Habits During and After Gestational Diabetes
GDM
Recruiting
Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center
Growth & Development, Breastfeeding Satisfaction
RecruitingObservational study
Evaluation of a Health Mediation Program in the Maternity Ward.
Breast Feeding, Exclusive
Recruiting
Hybrid Breastfeeding Education in Late Pregnancy: Effects on Antenatal Attachment and Breastfeeding
Breast Feeding, Exclusive Breast Feeding
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.
Brandon Guthrie, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Newborn Health Education in people with Breastfeeding, Exclusive and Immunization; Infection, run by University of Washington 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 15 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 Mar 2024. 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?
Results are not available in the source record.
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?
Mid-upper arm circumference (time frame: Up to six months). The study lists 2 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 NCT05111899, 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 20 Mar 2024.