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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04730570
Acronym
ECEM
Enrollment
150
Registered
2021-01-29
Start date
2021-01-05
Completion date
2022-01-21
Last updated
2023-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Distress

Keywords

maternal self-efficacy, postpartum depression, postpartum anxiety, mobile health education, postpartum support

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.

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.

Sponsors

Dalhousie University
CollaboratorOTHER
IWK Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Self EfficacyChange from enrolment (baseline) to six-weeksKaritane Parenting Confidence Scale (Minimum: 0, Maximum: 45; Higher score indicates greater self-efficacy)

Secondary

MeasureTime frameDescription
Postpartum anxietyChange from enrolment (baseline) to six-weeksPostpartum Specific Anxiety Scale (Minimum: 51, Maximum: 204; Higher score indicates higher anxiety)
Social supportChange from enrolment (baseline) to six-weeksMultidimensional 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).
Postpartum depressionChange from enrolment (baseline) to six-weeksEdinburgh Postnatal Depression Scale (Minimum: 0, Maximum: 30; Higher score indicates higher depression)
Self-EfficacyChange from six-weeks to six-months postpartumKaritane Parenting Confidence Scale (Minimum: 0, Maximum: 45; Higher score indicates greater self-efficacy)
Social SupportChange from six-weeks to six-months postpartumMultidimensional 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).

Other

MeasureTime frameDescription
Implementation extent (dose)Through study completion, an average of 6 weeksWhat was the dose received (i.e., number of messages received)?
Implementation quality6-weeks postpartumQualitative 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? \[open ended\]
Implementation extent (completion)Through study completion, an average of 6 weeksWhat was the completion rate (e.g., withdrawal rate)?
Implementation extent (Reach)Through study completion, an average of 1 yearWhat was the reach (i.e., enrolment rate)?

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026