NCT05362305

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
2.1 years until next milestone

Study Start

First participant enrolled

June 13, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

April 22, 2022

Last Update Submit

October 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Newborn Care Knowledge

    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.

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

Secondary Outcomes (8)

  • 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)

  • +3 more secondary outcomes

Other Outcomes (4)

  • Implementation Dose

    Enrolment and study completion (6 weeks)

  • Implementation Engagement

    Enrolment and study completion (6 weeks)

  • Recruitment Effectiveness

    Enrolment

  • +1 more other outcomes

Study Arms (2)

Essential Coaching for Every Mother

EXPERIMENTAL

Mothers in the intervention group will receive in-hospital education by a non-study nurse midwife while on the postnatal ward prior to discharge as per standard protocol on the unit. On the third day after birth, mothers will receive daily text messages to 6 weeks postpartum. The messages will be sent automatically each day based on the date of birth of the infant.

Behavioral: Essential Coaching for Every Mother

Standard Care

NO INTERVENTION

Mothers will receive in-person education provided by a non-study nurse midwife while on the postnatal ward prior to discharge as per current standard protocol on the unit. Mothers in this group will not receive any further text messages from the program.

Interventions

Daily text messages for the first six-weeks postpartum.

Essential Coaching for Every Mother

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

Location

Related Publications (1)

  • Dol J, Mselle LT, Campbell-Yeo M, Mbekenga C, Kohi T, McMillan D, Dennis CL, Tomblin Murphy G, Aston M. Essential Coaching for Every Mother Tanzania (ECEM-TZ): Protocol for a Type 1 Hybrid Effectiveness-Implementation Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 5;13:e63454. doi: 10.2196/63454.

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2022

First Posted

May 5, 2022

Study Start

June 13, 2024

Primary Completion

September 21, 2024

Study Completion

October 10, 2025

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations