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Clinical Trials/NCT05362305
NCT05362305Active, not recruitingNot Applicable

Essential Coaching for Every Mother: Developing and Evaluating a Text Message Postnatal Education Intervention for Mothers of Newborns in Tanzania

IWK Health Centre2 sites in 1 country124 target enrollmentStarted: June 13, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
124
Locations
2
Primary Endpoint
Newborn Care Knowledge

Study Overview

Brief Summary

The purpose of this study is to evaluate a text message intervention called Essential Coaching for Every Mother in Tanzania to improve mothers' access to essential newborn care information during the immediate six-week postnatal period.

Detailed Description

This is a 2-group parallel arm randomized controlled trial. Participants will be randomized into either the intervention or a control group. No changes to in-person care will occur.

This study will be conducted in Dar es Salaam, Tanzania with mothers recruited from a Tanzanian postnatal ward who have recently given birth at four different hospitals. Participants in the intervention group will start receiving the Essential Coaching for Every Mother program based on their delivery date up to six weeks postpartum. Mothers in the control group will not receive any text messages. Both groups will be asked to complete a survey at enrolment and six-weeks postpartum.

The investigators aim to recruitment 124 participants in total, 62 per group.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Care Provider)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • have recently given birth within the hospital within 48 hours
  • have daily access to a mobile phone with text message capabilities
  • are over 18 years of age
  • speak and read English or Swahili.

Exclusion Criteria

  • newborns die or are expected to die prior to leaving the hospital
  • they have no access to mobile phone, either personal or shared
  • unwilling to receive text messages
  • decline to participate
  • are experiencing major postnatal complications expected to impact learning or ability to consent while in the hospital (e.g., postpartum hemorrhage, seizures)
  • participated in Phase I of this project.

Outcomes

Primary Outcomes

Newborn Care Knowledge

Time Frame: Baseline (enrolment), and six-weeks postpartum (follow-up)

Knowledge will be assessed using a modified questionnaire developed by McConnell and colleagues. Questions will determine whether mothers can identify danger signs, hand washing practices, cord care, newborn thermal care, and breastfeeding. A summative score will be created with a maximum of five points and a minimum of zero, where each point represents knowledge on the above postnatal health topics.

Secondary Outcomes

  • Maternal Self-Efficacy(Baseline (enrolment), and six-weeks postpartum (follow-up))
  • Breastfeeding Self-Efficacy(Baseline (enrolment), and six-weeks postpartum (follow-up))
  • Postpartum Depression(Baseline (enrolment), and six-weeks postpartum (follow-up))
  • Postpartum Anxiety(Baseline (enrolment), and six-weeks postpartum (follow-up))
  • Newborn morbidity(Six-weeks postpartum (follow-up))
  • Newborn mortality(Six-weeks postpartum (follow-up))
  • Need for readmission(Six-weeks postpartum (follow-up))
  • Postnatal Clinic Attendance(Six-weeks postpartum (follow-up))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Justine Dol

Principal Investigator

Unity Health Toronto

Study Sites (2)

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