Clinical trial NCT04730570: Essential Coaching for Every Mother, a Postpartum Text Message Program for Canadian Mothers
Official title: Essential Coaching for Every Mother: A Randomized Controlled Trial Evaluating an Text Message Postpartum Program for Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Distress
Keywords: maternal self-efficacy
postpartum depression
postpartum anxiety
mobile health education
postpartum support
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2021-01-29
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The current study is a 2-group parallel arm randomized controlled trial, stratified by parity.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Self Efficacy
timeFrame: Change from enrolment (baseline) to six-weeks
Secondary outcomes:
measure: Social support
timeFrame: Change from enrolment (baseline) to six-weeks
measure: Postpartum anxiety
timeFrame: Change from enrolment (baseline) to six-weeks
measure: Postpartum depression
timeFrame: Change from enrolment (baseline) to six-weeks
measure: Self-Efficacy
timeFrame: Change from six-weeks to six-months postpartum
measure: Social Support
timeFrame: Change from six-weeks to six-months postpartum
measure: Postpartum anxiety
timeFrame: Change from six-weeks to six-months postpartum
measure: Postpartum depression
timeFrame: Change from six-weeks to six-months postpartum
Other outcomes:
measure: Implementation extent (Reach)
timeFrame: Through study completion, an average of 1 year
measure: Implementation extent (completion)
timeFrame: Through study completion, an average of 6 weeks
measure: Implementation extent (dose)
timeFrame: Through study completion, an average of 6 weeks
measure: Implementation quality
timeFrame: 6-weeks postpartum
Locations:
city: Halifax
country: Canada
facility: IWK Health
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Justine Dol, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.