Mobile Health Intervention to Improve Neonatal Care Practice

NCT05666050 | Completed DMC

• 1 other identifier: JUIH/IRB/230/22
• Study Type: interventional
• Target: 784
• Locations: 1 country
• Sites: 1

Brief Summary

Effectiveness of interactive mobile health intervention (IMHI) to improve neonatal care practice among postpartum women in Dessie and Kombolcha town zones, north east Ethiopia: behavioral cluster randomized control trial.

Conditions

Neonatal Care

Keywords

Neonatal care, Dessie, Kombolcha, Ethiopia

Outcome Measures

Primary Outcomes (1)

• Neonatal care practice among the intervention and control group will be measured by The minimum WHO 12 items will be used to produce composite index (score).

  Principal component analysis will be done to create composite index (score) and respondents who will have scored above or equal to the mean/median value will be considered as having good neonatal care, while those who will score below the mean/median value were considered as poor neonatal care.

  Two weeks after intervention the outcome will be measured.

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive mobile health intervention sending message service(SMS)

Behavioral: Mobile health intervention

Control group

NO INTERVENTION

The control group will receive the existed current health delivery approach, no mobile health sending message service

Interventions

Mobile health intervention BEHAVIORAL

Pregnant women with 26-28 weeks of gestation(based on world health organization eligibility criteria) will be recruited and baseline data will be collected at selected clusters. Women who will provide informed consent will be asked to complete a post-consent eligibility assessment including access to a mobile phone, and willingness to receive health messages on their mobile phone. Women who meet these eligibility criteria will be enrolled in the study and administered the baseline interview. Intervention will be started among randomly selected clustered pregnant women at 30 weeks of gestation and will be continued up to 6 weeks of post partum period for 4 months.

Intervention group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women 26-28 weeks of gestation and have mobile phone access in the study area.

You may not qualify if:

• Pregnant women seriously ill and not able to respond.

Sponsors & Collaborators

• Wollo University: lead
• Jimma University: collaborator

Study Sites (1)

Dessie and Kombolcha

Dessie, South Wollo, 1145, Ethiopia

Location

Related Publications (2)

• Cherie N, Abdulkerim M, Abegaz Z, Walle Baze G. Maternity continuum of care and its determinants among mothers who gave birth in Legambo district, South Wollo, northeast Ethiopia. Health Sci Rep. 2021 Nov 2;4(4):e409. doi: 10.1002/hsr2.409. eCollection 2021 Dec.

  PMID: 34754945 BACKGROUND

• Cherie N, Wordofa MA, Debelew GT. The effect of an interactive mobile health intervention to improve community-based essential neonatal care practices among postpartum women in northeast Ethiopia: a cluster randomized controlled trial. Int Health. 2025 Sep 3;17(5):820-835. doi: 10.1093/inthealth/ihae080.

  PMID: 39789852 DERIVED

Study Officials

• Niguss Cherie

  Wollo Universirty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors will be masked about which group is intervention and control to avoid bias.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Pregnant women with 26-28 weeks of gestation(based on world health organization eligibility criteria) will be recruited and baseline data will be collected at selected clusters. Women who will provide informed consent will be asked to complete a post-consent eligibility assessment including access to a mobile phone, and willingness to receive health messages on their mobile phone. Women who meet these eligibility criteria will be enrolled in the study and administered the baseline interview. Intervention will be started among randomly selected clustered pregnant women at 30 weeks of gestation and continued up to 6 weeks of post partum period for 4 months. Three intervention worker female nurses/midwifes will be recruited and trained to do the intervention based on the protocol After this end line data will be collected from both intervention and control group.

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 27, 2022
• Study Start: January 15, 2023
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)