Clinical trial NCT05362305: Essential Coaching for Every Mother in Tanzania
Official title: Essential Coaching for Every Mother: Developing and Evaluating a Text Message Postnatal Education Intervention for Mothers of Newborns in Tanzania
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parenting Self Efficacy
Postpartum Depression
Postpartum Anxiety
Breastfeeding Self-Efficacy
Newborn Knowledge
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Newborn Care Knowledge
timeFrame: Baseline (enrolment), and six-weeks postpartum (follow-up)
Secondary outcomes:
measure: Maternal Self-Efficacy
timeFrame: Baseline (enrolment), and six-weeks postpartum (follow-up)
measure: Breastfeeding Self-Efficacy
timeFrame: Baseline (enrolment), and six-weeks postpartum (follow-up)
measure: Postpartum Depression
timeFrame: Baseline (enrolment), and six-weeks postpartum (follow-up)
measure: Postpartum Anxiety
timeFrame: Baseline (enrolment), and six-weeks postpartum (follow-up)
measure: Newborn morbidity
timeFrame: Six-weeks postpartum (follow-up)
measure: Newborn mortality
timeFrame: Six-weeks postpartum (follow-up)
measure: Need for readmission
timeFrame: Six-weeks postpartum (follow-up)
measure: Postnatal Clinic Attendance
timeFrame: Six-weeks postpartum (follow-up)
Other outcomes:
measure: Implementation Dose
timeFrame: Enrolment and study completion (6 weeks)
measure: Implementation Engagement
timeFrame: Enrolment and study completion (6 weeks)
measure: Recruitment Effectiveness
timeFrame: Enrolment
measure: Implementation Quality
timeFrame: Six-weeks postpartum
Locations:
city: Dar Es Salaam
country: Tanzania
facility: Muhimbili University of Health and Allied Sciences
Study officials:
References: