NCT04730570

Brief Summary

The purpose of this study is to evaluate a text message-based program called Essential Coaching for Every Mother which sends daily text messages during the immediate six-week postnatal period. Essential Coaching for Every Mother consists of standardized text messages that provide evidence-based information that women should be aware of related to caring for their newborn and maternal mental health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 5, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2022

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

January 19, 2021

Last Update Submit

September 21, 2023

Conditions

Keywords

maternal self-efficacypostpartum depressionpostpartum anxietymobile health educationpostpartum support

Outcome Measures

Primary Outcomes (1)

  • Self Efficacy

    Karitane Parenting Confidence Scale (Minimum: 0, Maximum: 45; Higher score indicates greater self-efficacy)

    Change from enrolment (baseline) to six-weeks

Secondary Outcomes (7)

  • Social support

    Change from enrolment (baseline) to six-weeks

  • Postpartum anxiety

    Change from enrolment (baseline) to six-weeks

  • Postpartum depression

    Change from enrolment (baseline) to six-weeks

  • Self-Efficacy

    Change from six-weeks to six-months postpartum

  • Social Support

    Change from six-weeks to six-months postpartum

  • +2 more secondary outcomes

Other Outcomes (4)

  • Implementation extent (Reach)

    Through study completion, an average of 1 year

  • Implementation extent (completion)

    Through study completion, an average of 6 weeks

  • Implementation extent (dose)

    Through study completion, an average of 6 weeks

  • +1 more other outcomes

Study Arms (2)

Essential Coaching for Every Mother Intervention

EXPERIMENTAL

Women in the intervention arm will receive the Essential Coaching for Every Mother messages up to six-weeks postpartum. No changes in standard care.

Behavioral: Essential Coaching for Every Mother

Standard care

NO INTERVENTION

Women in the control group will receive no content messages. No changes in standard care.

Interventions

Essential Coaching for Every Mother consists of 53 standardized text messages that provide evidence-based information that women should be aware of related to caring for their newborn and maternal mental health. Messages are personalized with the name of the child. Messages sent from birth to six-weeks postpartum, with two messages sent per day in the first two weeks and a daily message for weeks 3-6. The following topics covered in Essential Coaching for Every Mother include anxiety, depression, maternal self-care, postnatal follow-up, breastfeeding or formula feeding, infant concerns, cord care, well-baby care, normal development, crying, and safe sleep. Women who receive the messages will be able to self-select breastfeeding or formula feeding messages.

Essential Coaching for Every Mother Intervention

Eligibility Criteria

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

You may qualify if:

  • To enroll antenatally, participants must:
  • be at least 37 weeks pregnant
  • have daily access to a mobile phone with text message capabilities
  • are over 18 years of age
  • speak and read English
  • live in Nova Scotia, Canada.
  • To enroll postnatally, participants must:
  • have an infant under 10 days of age
  • have daily access to a mobile phone with text message capabilities
  • are over 18 years of age
  • speak and read English
  • live in Nova Scotia, Canada.

You may not qualify if:

  • newborn 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 or withdraw to participate
  • participated in Phase I of this project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IWK Health

Halifax, Nova Scotia, Canada

Location

Related Publications (3)

  • Dol J, Aston M, McMillan D, Tomblin Murphy G, Campbell-Yeo M. Effectiveness of a Postpartum Text Message Program (Essential Coaching for Every Mother) on Maternal Psychosocial Outcomes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Mar 25;10(3):e27138. doi: 10.2196/27138.

    PMID: 33764309BACKGROUND
  • Dol J, Aston M, McMillan D, Tomblin Murphy G, Campbell-Yeo M. Participants' Perceptions of Essential Coaching for Every Mother-a Canadian Text Message-Based Postpartum Program: Process Evaluation of a Randomized Controlled Trial. JMIR Form Res. 2022 May 13;6(5):e36821. doi: 10.2196/36821.

    PMID: 35559855BACKGROUND
  • Dol J, Tomblin Murphy G, Aston M, McMillan D, Campbell-Yeo M. Design, development and usability testing of Essential Coaching for Every Mother: A postnatal text message educational intervention. Women Birth. 2021 May;34(3):e228-e236. doi: 10.1016/j.wombi.2020.05.004. Epub 2020 May 29.

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

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

Study Officials

  • Justine Dol, MSc

    Dalhousie University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Blinding is not possible for participants and thus participants will be informed of their group allocation. To minimize personnel blinding related to data collection, no hospital staff (nurse midwives, physicians, other healthcare providers) are required to be aware of participant's involvement in the study. This is possible as Essential Coaching for Every Mother is sent to the participant's personal cell phone with no intervention occurring in person. The PI will be aware of participant allocation and will be responsible for collecting data but will not be involved in the randomization procedure which occurs directly in the TextIt platform. Additionally, there is no interaction with the participants from the PI or anyone on the research team as everything occurs remotely via a previously set up process, reducing any risk of influencing participant response and influencing outcome assessment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The current study is a 2-group parallel arm randomized controlled trial, stratified by parity.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 29, 2021

Study Start

January 5, 2021

Primary Completion

July 13, 2021

Study Completion

January 21, 2022

Last Updated

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations