Leading Advancements in the Uptake of Newborn Community Health

NCT05111899 | Active Not Recruiting

• 1 other identifier: STUDY00006942
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Breastfeeding, Exclusive; Immunization; Infection; Growth; Stunting, Nutritional

Keywords

Community health worker

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Immunization status

  Up to six months

• Frequency of acute illness

  Up to six months

• Frequency of hospitalization status

  Up to six months

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Newborn Health Education

Control

NO INTERVENTION

Interventions

Newborn Health Education BEHAVIORAL

Community influencers will receive training and give community education to women and their families regarding newborn health.

Intervention

Eligibility Criteria

• Age: 14 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Mothers must give written informed consent for themselves and their newborn
• Formative focus group discussion and key informant interview participants (FGD and KII participants)
• 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

You may not qualify if:

• 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
• 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)
• \- Newly established residence in the Woreda (\<6 months)

Sponsors & Collaborators

• University of Washington: lead
• Frankel Family Foundation: collaborator
• Stewardship Foundation: collaborator

Study Sites (1)

University of Gondar

Gonder, Amhara, P.O. Box 126, Ethiopia

Location

Related Publications (1)

• 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.

  PMID: 39277203 DERIVED

MeSH Terms

Conditions

Breast Feeding; Infections; Growth Disorders

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brandon Guthrie, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Public Health: Global Health

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: November 8, 2021
• Study Start: July 11, 2022
• Primary Completion: August 22, 2023
• Study Completion: April 1, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

ET (1)