Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05362305

Essential Coaching for Every Mother in Tanzania

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Parenting Self Efficacy Breastfeeding Self-Efficacy Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Newborn Knowledge Postpartum Anxiety Postpartum Depression Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Essential Coaching for Every Mother

Behavioral

Daily text messages for the first six-weeks postpartum.

Primary outcomes

  1. 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

  1. Maternal Self-Efficacy

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

    Parenting self-efficacy will be measured using the Karitane Parenting Confidence Scale (KPCS) tool. This 15-item tool was developed to assess perceived self-efficacy of mothers of newborns birth to twelve months of age. A cut off score of 39 or less (out of a possible 45) was determine to be a clinically low perceived parenting self-efficacy (PPSE).

  2. Breastfeeding Self-Efficacy

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

    Breastfeeding self-efficacy will be measured using the Breastfeeding Self-Efficacy Scale - Short Form. Higher scores indicate higher breastfeeding self-efficacy.

  3. Postpartum Depression

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

    Depression will be measured using the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a self-report screening scale with 10 items that can indicate if a respondent has symptoms related to perinatal depression with a score >12 considered high symptoms of depression.

  4. Postpartum Anxiety

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

    Anxiety will be measured using the Generalized Anxiety Disorder (GAD)-7, which is a 7-item scale used to assess generalized anxiety disorder. The scale ranges between 0 and 21, with scores of 10 or greater indicative of generalized anxiety at a moderate/severe level.

  5. Newborn morbidity

    Time frame: Six-weeks postpartum (follow-up)

    Data will be collected on number of morbidities (e.g., diarrhea, jaundice, infection) identified per infant enrolled in the study within the 6-weeks.

  6. Newborn mortality

    Time frame: Six-weeks postpartum (follow-up)

    Data will be collected on newborn mortality (e.g., number of infant deaths during study).

  7. Need for readmission

    Time frame: Six-weeks postpartum (follow-up)

    Data will be collected on number of readmission to hospital for the infant and mothers during the six weeks and related reason.

  8. Postnatal Clinic Attendance

    Time frame: Six-weeks postpartum (follow-up)

    Data will be collected on the number and date of postnatal contact.

Other outcomes

  1. Implementation Dose

    Time frame: Enrolment and study completion (6 weeks)

    Dose delivered - number of text messages sent. Output data available through the Africa's Talking and TextIt platforms will be collected per participant.

  2. Implementation Engagement

    Time frame: Enrolment and study completion (6 weeks)

    Un-subscription rates/drop out after enrolment. Output data available through the Africa's Talking and TextIt platforms will be collected per participant.

  3. Recruitment Effectiveness

    Time frame: Enrolment

    Number of participants enrolled versus approached. Number of participants per hospital site.

  4. Implementation Quality

    Time frame: Six-weeks postpartum

    Mothers in the intervention group will be asked about the number of messages they recall receiving, user experience, perspectives on the frequency and timing of messages, and what did they like and not like about Essential Coaching for Every Mother.

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Registry information

Official study title

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

Acronym: ECEMTZ

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 5, 2022
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.