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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-05

Study Completion Date

2022-01-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Maternal Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The current study is a 2-group parallel arm randomized controlled trial, stratified by parity.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Essential Coaching for Every Mother

Intervention Type 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.

Standard care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes