Skip to main content
OpenTrials
Completed

NCT Number: NCT04730570

Essential Coaching for Every Mother, a Postpartum Text Message Program for Canadian 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Maternal Distress Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IWK Health

Halifax, Nova Scotia, Canada

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, 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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Essential Coaching for Every Mother

Behavioral

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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).

  2. Postpartum anxiety

    Time frame: Change from enrolment (baseline) to six-weeks

    Postpartum Specific Anxiety Scale (Minimum: 51, Maximum: 204; Higher score indicates higher anxiety)

  3. Postpartum depression

    Time frame: Change from enrolment (baseline) to six-weeks

    Edinburgh Postnatal Depression Scale (Minimum: 0, Maximum: 30; Higher score indicates higher depression)

  4. 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)

  5. 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).

  6. 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)

  7. 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)

Other outcomes

  1. Implementation extent (Reach)

    Time frame: Through study completion, an average of 1 year

    What was the reach (i.e., enrolment rate)?

  2. Implementation extent (completion)

    Time frame: Through study completion, an average of 6 weeks

    What was the completion rate (e.g., withdrawal rate)?

  3. Implementation extent (dose)

    Time frame: Through study completion, an average of 6 weeks

    What was the dose received (i.e., number of messages received)?

  4. 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]

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Collaborators

  • Dalhousie University

Registry information

Official study title

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

Acronym: ECEM

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 29, 2021
Registry last updated
Sep 25, 2023

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.