Essential Coaching for Every Mother in Tanzania

NCT ID: NCT05362305

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-13
• Study Completion Date: 2025-10-10

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.

Conditions

Parenting Self Efficacy; Postpartum Depression; Postpartum Anxiety; Breastfeeding Self-Efficacy; Newborn Knowledge

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Essential Coaching for Every Mother

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.

Group Type: EXPERIMENTAL

Essential Coaching for Every Mother

Intervention Type: BEHAVIORAL

Daily text messages for the first six-weeks postpartum.

Standard Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Essential Coaching for Every Mother

Daily text messages for the first six-weeks postpartum.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

IWK Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Justine Dol

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Muhimbili University of Health and Allied Sciences

Dar es Salaam, , Tanzania

Countries

Tanzania

References

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.

Reference Type: DERIVED

PMID: 39636672 (View on PubMed)

Other Identifiers

ECEMTZ

Identifier Type: -

Identifier Source: org_study_id