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| Name | Class |
|---|---|
| Frankel Family Foundation | UNKNOWN |
| Stewardship Foundation | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Newborn Health Education | Behavioral | Community influencers will receive training and give community education to women and their families regarding newborn health. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mid-upper arm circumference | Anthropometric Measurement using MUAC tapes | Up to six months |
| Proportion of mothers exclusive breastfeeding | Self-reported breastfeeding behavior | Up to six months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunization status | Collected from vaccination cards | Up to six months |
| Frequency of acute illness | Self reported | Up to six months |
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Inclusion Criteria:
Newborn-mother pairs visited by the study staff (Enrolled women and newborns)
The following inclusion criteria will be used during recruitment:
Formative focus group discussion and key informant interview participants (FGD and KII participants)
The following inclusion criteria will be used during recruitment:
Exclusion Criteria:
Newborn-mother pairs visited by the study staff (Enrolled women and newborns)
The following exclusion criteria will be used during recruitment:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Brandon Guthrie, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Gondar | Gonder | Amhara | P.O. Box 126 | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39277203 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2021 | Aug 18, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D007239 | Infections |
| D006130 | Growth Disorders |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Frequency of hospitalization status | Self reported | Up to six months |