Essential Coaching for Every Mother, a Postpartum Text Message Program for Canadian Mothers (ECEM)

September 21, 2023 updated by: Justine Dol, IWK Health Centre

Essential Coaching for Every Mother: A Randomized Controlled Trial Evaluating an Text Message Postpartum Program for Mothers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a 2-group parallel arm randomized controlled trial. Participants will be randomized into either the intervention or a control group, stratified by parity. No changes to in-person care will occur.

Mothers in the intervention group will receive daily text messages from enrollment after birth until six-weeks postpartum.

Mothers in the control group will receive no content messages.

Mothers will be recruited both antenatally and postnatally through social media and study posters. All recruitment and participant engagement will occur remotely via text message. Women who are 37+ weeks pregnant up to 10 days postpartum will be eligible to send a text to a study specific number and complete an eligibility screening. If determined eligible once they deliver, the participant will be randomized into the intervention or control group and they will be asked to complete an electronic consent form and the baseline survey. 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 only receive reminder texts to complete the follow-up surveys. Both groups will be asked to complete an online survey at enrolment, six-weeks and six-months postpartum.

The investigators aim to recruitment 140 participants in total, 70 per group.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • IWK Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Essential Coaching for Every Mother Intervention
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
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.
No Intervention: Standard care
Women in the control group will receive no content messages. No changes in standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self Efficacy
Time Frame: Change from enrolment (baseline) to six-weeks
Karitane Parenting Confidence Scale (Minimum: 0, Maximum: 45; Higher score indicates greater self-efficacy)
Change from enrolment (baseline) to six-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social support
Time Frame: Change from enrolment (baseline) to six-weeks
Multidimensional Scale of Perceived Social Support (For the sub-scales of family, friends, and significant other [Minimum: 0, Maximum: 4]; for the total score, [Minimum: 0, Maximum: 12]; higher scores indicate greater support).
Change from enrolment (baseline) to six-weeks
Postpartum anxiety
Time Frame: Change from enrolment (baseline) to six-weeks
Postpartum Specific Anxiety Scale (Minimum: 51, Maximum: 204; Higher score indicates higher anxiety)
Change from enrolment (baseline) to six-weeks
Postpartum depression
Time Frame: Change from enrolment (baseline) to six-weeks
Edinburgh Postnatal Depression Scale (Minimum: 0, Maximum: 30; Higher score indicates higher depression)
Change from enrolment (baseline) to six-weeks
Self-Efficacy
Time Frame: Change from six-weeks to six-months postpartum
Karitane Parenting Confidence Scale (Minimum: 0, Maximum: 45; Higher score indicates greater self-efficacy)
Change from six-weeks to six-months postpartum
Social Support
Time Frame: Change from six-weeks to six-months postpartum
Multidimensional Scale of Perceived Social Support (For the sub-scales of family, friends, and significant other [Minimum: 0, Maximum: 4]; for the total score, [Minimum: 0, Maximum: 12]; higher scores indicate greater support).
Change from six-weeks to six-months postpartum
Postpartum anxiety
Time Frame: Change from six-weeks to six-months postpartum
Postpartum Specific Anxiety Scale (Minimum: 51, Maximum: 204; Higher score indicates higher anxiety)
Change from six-weeks to six-months postpartum
Postpartum depression
Time Frame: Change from six-weeks to six-months postpartum
Edinburgh Postnatal Depression Scale (Minimum: 0, Maximum: 30; Higher score indicates higher depression)
Change from six-weeks to six-months postpartum

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementation extent (Reach)
Time Frame: Through study completion, an average of 1 year
What was the reach (i.e., enrolment rate)?
Through study completion, an average of 1 year
Implementation extent (completion)
Time Frame: Through study completion, an average of 6 weeks
What was the completion rate (e.g., withdrawal rate)?
Through study completion, an average of 6 weeks
Implementation extent (dose)
Time Frame: Through study completion, an average of 6 weeks
What was the dose received (i.e., number of messages received)?
Through study completion, an average of 6 weeks
Implementation quality
Time Frame: 6-weeks postpartum

Qualitative feedback on program:

  • What did you like most about Essential Coaching for Every Mother? [open ended]
  • What did you like least about Essential Coaching for Every Mother? [open ended]
  • Did you face any barriers with acting on the information received from Essential Coaching for Every Mother at home (e.g., geographical impacts, cellular access, health seeking opportunities)? If yes, please describe. [open ended]
  • How can Essential Coaching for Every Mother be improved further? [open ended]
6-weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IWK Health Centre

Collaborators

Dalhousie University

Investigators

  • Principal Investigator: Justine Dol, MSc, Dalhousie University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2021

Primary Completion (Actual)

July 13, 2021

Study Completion (Actual)

January 21, 2022

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 26, 2021

First Posted (Actual)

January 29, 2021

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1024984

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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