PregnancyNCT05793944
SmartMom: Teaching by Texting to Promote Health Behaviours in Pregnancy
A study testing SmartMom text messaging in people with Pregnancy, run by University of British Columbia at 1 site in Canada.
Trial summary
The goal of this randomized clinical trial is to evaluate the effectiveness of SmartMom, a text messaging-based mobile health program for prenatal education. The main questions are to determine if healthy pregnant people receiving SmartMom messages that promote health behaviours in pregnancy versus messages that don't… Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- SmartMom text messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,078 participants
- Where
- 1 siteCanada
- Study dates
- 10 Nov 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- pregnant person
- at 15 weeks gestation or earlier
- singleton pregnancy
- can read and understand English at grade 8 level and comfortable completing online surveys
- live in Canada (excluding British Columbia where SmartMom has been piloted)
Who cannot join
- health conditions existing prior to pregnancy that require individualized care (e.g. hypertension, cardiac disease, diabetes)
- previously had a baby with the SmartMom program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
BC Children's Hospital Research Institute
Vancouver, British Columbia
Sara Leckie, MSc, 604-875-2345 ext. 5415, sara.leckie@ubc.ca
About this study
Official title: Teaching by Texting to Promote Health Behaviours in Pregnancy
The goal of this randomized clinical trial is to evaluate the effectiveness of SmartMom, a text messaging-based mobile health program for prenatal education. The main questions are to determine if healthy pregnant people receiving SmartMom messages that promote health behaviours in pregnancy versus messages that don't provoke behaviour change have improvement in:
- knowledge about healthy pregnancy and birth
- standardized measures of depression, anxiety, and fear of childbirth
- adoption of positive health behaviours in pregnancy
- maternal, fetal, and newborn outcomes
Read more
Participants in the intervention group will receive three evidence-based text messages per week, plus optional supplemental messages on topics relevant to them, throughout pregnancy.
The control group will receive general interest messages on pregnancy-related topics that are not promoting behaviour change.
- Conditions
- Pregnancy
- Being tested
- SmartMom text messaging, Control text messaging
- Keywords
- prenatal education, perinatal outcomes, text messaging, mobile health, mental health, health behaviour
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartMom text messagingBehavioural
SmartMom is a mobile health program delivered via text messaging that guides participants through each week of pregnancy. Participants receive three messages per week with links to content focused on improving knowledge, providing information about prenatal assessments and screening, and encouraging the adoption of behaviours to support healthy pregnancy and physiologic birth. Messages are consistent with current professional guidelines and peer reviewed prenatal education curricula. SmartMom provides optional supplemental streams for individuals who wish to have additional messages addressing topics such as reducing use of tobacco, alcohol or illicit drugs, depression, obesity, and maternal age over 35.
Control text messagingBehavioural
Control arm participants will receive weekly text messages with accurate, general-interest information about pregnancy and about progress of the trial. Content is not geared to decision-making during pregnancy that may affect health outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: SmartMom messaging | Active comparator | Participants receive three text messages per week with evidence-based information to promote healthy behaviours during pregnancy. Receives: Behavioral: SmartMom text messaging |
| Control messaging | Placebo comparator | Participants receive one text message per week with general information about pregnancy but not about making healthy choices. Receives: Behavioral: Control text messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight during pregnancy
Rate of pregnancy weight gain in a range appropriate for pre-pregnancy BMI. These include self-reported data as well as data from provincial prenatal registries and the Canadian Hospital Discharge Database linked via personal health number, provided as part of the consenting procedure.
Measured: Enrollment, 38 weeks gestation
Attendance at prenatal care visits through pregnancy
Rates of attendance at prenatal care appointments in adherence to Canadian guidelines. These include self-reported data as well as data from provincial prenatal registries and the Canadian Hospital Discharge Database linked via personal health number, provided as part of the consenting procedure.
Measured: 38 weeks gestation
Secondary outcomes (10)
Changes in health knowledge through pregnancy
Changes in health knowledge as measured by a 10-item knowledge test. Minimum score = 0, Maximum score = 10. Higher score indicates more knowledge i.e. more positive outcome.
Measured: Enrollment, 38 weeks gestation
Health literacy at end of pregnancy
Health literacy as measured by self-report of i) information-seeking from local health and social services resources; ii) awareness of their choices regarding serum genetic screening; iii) awareness of their choices to have (yes/no) serum glucose screening.
Measured: 38 weeks gestation
Changes in fear of childbirth through pregnancy
Changes in fear of childbirth as measured by The Childbirth Fear Scale, an 11-item, self-reported measure.
Minimum score = 6, Maximum score = 66. Lower score means less fear, i.e. a more positive outcome.
Measured: Enrollment, 38 weeks gestational age
Changes in depression through pregnancy
Changes in depression as measured by the Edinburgh Postnatal Depression Scale. This is a 10-item, self-report screening tool for postnatal depression that is also valid for use during pregnancy.
Minimum score = 0. zero, Maximum score = 30. Lower score means less depression, i.e. a more positive outcome.
Measured: Enrollment, 38 weeks gestational age
Changes in anxiety through pregnancy
Changes in anxiety as measured by the standardized 33-item Pregnancy Specific Anxiety Tool (PSAT).
Minimum score = 6, Maximum score = 24. Lower score means less anxiety, i.e. a more positive outcome.
Measured: Enrollment, 38 weeks gestational age
Changes in use of tobacco, vaping, alcohol, or cannabis through pregnancy among users.
Among participants indicating that they are users of tobacco, vaping, alcohol, and/or cannabis at enrollment, change of use at the end of pregnancy will be measured by self-report.
Report: proportion of users that stopped using per trial arm. Among users continuing to use: mean change in number of daily cigarettes, episodes of vaping, drinks per week, cannabis products per day or other specified use of recreational or prescription drugs used per day.
Measured: Enrollment, 38 weeks gestational age
Rates of planned vaginal birth after cesarean
Proportion of participants choosing to plan vaginal birth (VBAC) after a previous cesarean birth, among those deemed eligible by their caregivers.
These include self-reported data as well as data from provincial prenatal registries and the Canadian Hospital Discharge Database linked via personal health number, provided as part of the consenting procedure.
Measured: 38 weeks gestation
Rates of exclusive breastfeeding at hospital discharge
These include self-reported data as well as data from provincial prenatal registries and the Canadian Hospital Discharge Database linked via personal health number, provided as part of the consenting procedure.
Measured: 1 month post birth
Rates of adverse pregnancy outcomes as measured by gestational diabetes, stillbirth, preterm birth (<37 weeks gestation) and small for gestational age (SGA) status at birth.
These include self-reported data as well as data from provincial prenatal registries and the Canadian Hospital Discharge Database linked via personal health number, provided as part of the consenting procedure.
Measured: 1 month post birth
Incremental costs per incidence of suboptimal weight gain and inadequate prenatal care avoided.
Incremental costs per incidence of suboptimal weight gain and inadequate prenatal care avoided for the intervention group when compared to control group as an incremental cost-effectiveness ratio.
Measured: Throughout pregnancy (up to 42 weeks) and birth, including hospital admission in which birth took place (up to 7 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start10 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,078 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Patricia Janssen, University of British Columbia
- Investigators
- Patti Janssen, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793944
- Sponsor's protocol ID
- H22-00603
- Status last verified
- Apr 2026
- First submitted
- 30 Jan 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available from the corresponding author upon reasonable request including a research proposal outlining how the data will be used and a certificate of ethical approval from an academic ethics review board.
Publications
Debessai Y, Costanian C, Roy M, El-Sayed M, Tamim H. Inadequate prenatal care use among Canadian mothers: findings from the Maternity Experiences Survey. J Perinatol. 2016 Jun;36(6):420-6. doi: 10.1038/jp.2015.218. Epub 2016 Jan 21.
PubMed 26796126Dzakpasu S, Fahey J, Kirby RS, Tough SC, Chalmers B, Heaman MI, Bartholomew S, Biringer A, Darling EK, Lee LS, McDonald SD. Contribution of prepregnancy body mass index and gestational weight gain to adverse neonatal outcomes: population attributable fractions for Canada. BMC Pregnancy Childbirth. 2015 Feb 5;15:21. doi: 10.1186/s12884-015-0452-0.
PubMed 25652811Ganer Herman H, Dekalo A, Jubran L, Schreiber L, Bar J, Kovo M. Obstetric outcomes and placental findings in gestational diabetes patients according to maternal prepregnancy weight and weight gain. J Matern Fetal Neonatal Med. 2019 May;32(10):1682-1687. doi: 10.1080/14767058.2017.1416078. Epub 2018 Feb 5.
PubMed 29402158Munro S, Hui A, Salmons V, Solomon C, Gemmell E, Torabi N, Janssen PA. SmartMom Text Messaging for Prenatal Education: A Qualitative Focus Group Study to Explore Canadian Women's Perceptions. JMIR Public Health Surveill. 2017 Feb 7;3(1):e7. doi: 10.2196/publichealth.6949.
PubMed 28174149van den Heuvel JF, Groenhof TK, Veerbeek JH, van Solinge WW, Lely AT, Franx A, Bekker MN. eHealth as the Next-Generation Perinatal Care: An Overview of the Literature. J Med Internet Res. 2018 Jun 5;20(6):e202. doi: 10.2196/jmir.9262.
PubMed 29871855Ennis M, Renner RM, Morando-Stokoe C, James S, Janssen PA, Leckie S, Dunn S, Mazza D, Norman WV. Exploring Methods to Mitigate Fraud in Web-Based Surveys: Multicase Study Analysis. J Med Internet Res. 2025 Dec 1;27:e78671. doi: 10.2196/78671.
PubMed 41324984Janssen P, Lecke S, Renner R, Zhang W, Vedam S, Norman WV, Bayrampour H, Tough S, Murray J, Muhajarine N, Dennis CL. Teaching by texting to promote positive health behaviours in pregnancy: a protocol for a randomised controlled trial of SmartMom. BMJ Open. 2024 Jan 18;14(1):e081730. doi: 10.1136/bmjopen-2023-081730.
PubMed 38238058
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching by Texting to Promote Health Behaviours in Pregnancy
- ClinicalTrials.gov ID
- NCT05793944
- Acronym / sponsor ID
- H22-00603
- Conditions
- Pregnancy
- Keywords
- prenatal education, perinatal outcomes, text messaging, mobile health, mental health, health behaviour
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,078 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized clinical trial is to evaluate the effectiveness of SmartMom, a text messaging-based mobile health program for prenatal education. The main questions are to determine if healthy pregnant people receiving SmartMom messages that promote health behaviours in pregnancy versus messages that don't provoke behaviour change have improvement in:
- knowledge about healthy pregnancy and birth
- standardized measures of depression, anxiety, and fear of childbirth
- adoption of positive health behaviours in pregnancy
- maternal, fetal, and newborn outcomes
Participants in the intervention group will receive three evidence-based text messages per week, plus optional supplemental messages on topics relevant to them, throughout pregnancy.
The control group will receive general interest messages on pregnancy-related topics that are not promoting behaviour change.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: SmartMom messaging | Active comparator | Behavioral: SmartMom text messagingParticipants receive three text messages per week with evidence-based information to promote healthy behaviours during pregnancy. |
| Control messaging | Placebo comparator | Behavioral: Control text messagingParticipants receive one text message per week with general information about pregnancy but not about making healthy choices. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- pregnant person
- at 15 weeks gestation or earlier
- singleton pregnancy
- can read and understand English at grade 8 level and comfortable completing online surveys
- live in Canada (excluding British Columbia where SmartMom has been piloted)
Key exclusion criteria (2 listed)
- health conditions existing prior to pregnancy that require individualized care (e.g. hypertension, cardiac disease, diabetes)
- previously had a baby with the SmartMom program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartMom text messagingSmartMom is a mobile health program delivered via text messaging that guides participants through each week of pregnancy. Participants receive three messages per week with links to content focused on improving knowledge, providing information about prenatal assessments and screening, and encouraging the adoption of behaviours to support healthy pregnancy and physiologic birth. Messages are consistent with current professional guidelines and peer reviewed prenatal education curricula. SmartMom provides optional supplemental streams for individuals who wish to have additional messages addressing topics such as reducing use of tobacco, alcohol or illicit drugs, depression, obesity, and maternal age over 35. | Behavioural | Intervention: SmartMom messaging |
| Control text messagingControl arm participants will receive weekly text messages with accurate, general-interest information about pregnancy and about progress of the trial. Content is not geared to decision-making during pregnancy that may affect health outcomes. | Behavioural | Control messaging |
Primary outcome
Change in weight during pregnancy
Time frame: Enrollment, 38 weeks gestation
Rate of pregnancy weight gain in a range appropriate for pre-pregnancy BMI. These include self-reported data as well as data from provincial prenatal registries and the Canadian Hospital Discharge Database linked via personal health number, provided as part of the consenting procedure.
Attendance at prenatal care visits through pregnancy
Time frame: 38 weeks gestation
Rates of attendance at prenatal care appointments in adherence to Canadian guidelines. These include self-reported data as well as data from provincial prenatal registries and the Canadian Hospital Discharge Database linked via personal health number, provided as part of the consenting procedure.
10 secondary outcomes
Changes in health knowledge through pregnancy
Time frame: Enrollment, 38 weeks gestation
Health literacy at end of pregnancy
Time frame: 38 weeks gestation
Changes in fear of childbirth through pregnancy
Time frame: Enrollment, 38 weeks gestational age
Changes in depression through pregnancy
Time frame: Enrollment, 38 weeks gestational age
Changes in anxiety through pregnancy
Time frame: Enrollment, 38 weeks gestational age
Changes in use of tobacco, vaping, alcohol, or cannabis through pregnancy among users.
Time frame: Enrollment, 38 weeks gestational age
Rates of planned vaginal birth after cesarean
Time frame: 38 weeks gestation
Rates of exclusive breastfeeding at hospital discharge
Time frame: 1 month post birth
Rates of adverse pregnancy outcomes as measured by gestational diabetes, stillbirth, preterm birth (<37 weeks gestation) and small for gestational age (SGA) status at birth.
Time frame: 1 month post birth
Incremental costs per incidence of suboptimal weight gain and inadequate prenatal care avoided.
Time frame: Throughout pregnancy (up to 42 weeks) and birth, including hospital admission in which birth took place (up to 7 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 26796126Debessai Y, Costanian C, Roy M, El-Sayed M, Tamim H. Inadequate prenatal care use among Canadian mothers: findings from the Maternity Experiences Survey. J Perinatol. 2016 Jun;36(6):420-6. doi: 10.1038/jp.2015.218. Epub 2016 Jan 21.
- Background: PubMed 25652811Dzakpasu S, Fahey J, Kirby RS, Tough SC, Chalmers B, Heaman MI, Bartholomew S, Biringer A, Darling EK, Lee LS, McDonald SD. Contribution of prepregnancy body mass index and gestational weight gain to adverse neonatal outcomes: population attributable fractions for Canada. BMC Pregnancy Childbirth. 2015 Feb 5;15:21. doi: 10.1186/s12884-015-0452-0.
- Background: PubMed 29402158Ganer Herman H, Dekalo A, Jubran L, Schreiber L, Bar J, Kovo M. Obstetric outcomes and placental findings in gestational diabetes patients according to maternal prepregnancy weight and weight gain. J Matern Fetal Neonatal Med. 2019 May;32(10):1682-1687. doi: 10.1080/14767058.2017.1416078. Epub 2018 Feb 5.
- Background: PubMed 28174149Munro S, Hui A, Salmons V, Solomon C, Gemmell E, Torabi N, Janssen PA. SmartMom Text Messaging for Prenatal Education: A Qualitative Focus Group Study to Explore Canadian Women's Perceptions. JMIR Public Health Surveill. 2017 Feb 7;3(1):e7. doi: 10.2196/publichealth.6949.
- Background: PubMed 29871855van den Heuvel JF, Groenhof TK, Veerbeek JH, van Solinge WW, Lely AT, Franx A, Bekker MN. eHealth as the Next-Generation Perinatal Care: An Overview of the Literature. J Med Internet Res. 2018 Jun 5;20(6):e202. doi: 10.2196/jmir.9262.
- Derived from this study: PubMed 41324984Ennis M, Renner RM, Morando-Stokoe C, James S, Janssen PA, Leckie S, Dunn S, Mazza D, Norman WV. Exploring Methods to Mitigate Fraud in Web-Based Surveys: Multicase Study Analysis. J Med Internet Res. 2025 Dec 1;27:e78671. doi: 10.2196/78671.
- Derived from this study: PubMed 38238058Janssen P, Lecke S, Renner R, Zhang W, Vedam S, Norman WV, Bayrampour H, Tough S, Murray J, Muhajarine N, Dennis CL. Teaching by texting to promote positive health behaviours in pregnancy: a protocol for a randomised controlled trial of SmartMom. BMJ Open. 2024 Jan 18;14(1):e081730. doi: 10.1136/bmjopen-2023-081730.
- Individual participant dataSharing planned: Yes. Individual participant data will be available from the corresponding author upon reasonable request including a research proposal outlining how the data will be used and a certificate of ethical approval from an academic ethics review board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patti Janssen, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartMom text messaging in people with Pregnancy, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Leckie, MSc (604-875-2345 ext. 5415, sara.leckie@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight during pregnancy (time frame: Enrollment, 38 weeks gestation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05793944, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.