NCT05793944

Brief 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 provoke behaviour change have improvement in:

  1. 1.knowledge about healthy pregnancy and birth
  2. 2.standardized measures of depression, anxiety, and fear of childbirth
  3. 3.adoption of positive health behaviours in pregnancy
  4. 4.maternal, fetal, and newborn outcomes

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,078

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
12mo left

Started Nov 2023

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Nov 2023Jun 2027

First Submitted

Initial submission to the registry

January 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

November 10, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

January 30, 2023

Last Update Submit

April 28, 2026

Conditions

Keywords

prenatal educationperinatal outcomestext messagingmobile healthmental healthhealth behaviour

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    38 weeks gestation

Secondary Outcomes (10)

  • Changes in health knowledge through pregnancy

    Enrollment, 38 weeks gestation

  • Health literacy at end of pregnancy

    38 weeks gestation

  • Changes in fear of childbirth through pregnancy

    Enrollment, 38 weeks gestational age

  • Changes in depression through pregnancy

    Enrollment, 38 weeks gestational age

  • Changes in anxiety through pregnancy

    Enrollment, 38 weeks gestational age

  • +5 more secondary outcomes

Study Arms (2)

Intervention: SmartMom messaging

ACTIVE COMPARATOR

Participants receive three text messages per week with evidence-based information to promote healthy behaviours during pregnancy.

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.

Behavioral: Control text messaging

Interventions

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.

Intervention: SmartMom messaging

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.

Control messaging

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • health conditions existing prior to pregnancy that require individualized care (e.g. hypertension, cardiac disease, diabetes)
  • previously had a baby with the SmartMom program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Children's Hospital Research Institute

Vancouver, British Columbia, Canada

RECRUITING

Related Publications (7)

  • 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.

    PMID: 26796126BACKGROUND
  • Dzakpasu 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.

    PMID: 25652811BACKGROUND
  • Ganer 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.

    PMID: 29402158BACKGROUND
  • Munro 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.

    PMID: 28174149BACKGROUND
  • van 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.

    PMID: 29871855BACKGROUND
  • Ennis 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.

  • Janssen 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.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Patti Janssen, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Leckie, MSc

CONTACT

Patti Janssen, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 30, 2023

First Posted

March 31, 2023

Study Start

November 10, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
At completion of study enrollment for five years
Access Criteria
Available to academic researchers who have submitted a research protocol that has been approved by a university ethics board.

Locations