SmartMom: Teaching by Texting to Promote Health Behaviours in Pregnancy

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:

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

• Status: Recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Behavioral: SmartMom text messaging; Behavioral: Control text messaging

• Study Type: Interventional
• Enrollment (Estimated): 3078
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Leckie, MSc; Phone Number: 5415 604-875-2345; Email: sara.leckie@ubc.ca
• Study Contact Backup: Name: Patti Janssen, PhD; Phone Number: 604-313-8243; Email: patti.janssen@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Recruiting
      • BC Children's Hospital Research Institute
      • Contact: Sara Leckie, MSc; Phone Number: 5415 604-875-2345; Email: sara.leckie@ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention: SmartMom messaging; Participants receive three text messages per week with evidence-based information to promote healthy behaviours during pregnancy.	Behavioral: SmartMom text messaging; 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.
Placebo Comparator: Control messaging; Participants receive one text message per week with general information about pregnancy but not about making healthy choices.	Behavioral: Control text 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	38 weeks gestation
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.	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.	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.	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.	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.	1 month post birth
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.	Enrollment, 38 weeks gestational age
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.	Enrollment, 38 weeks gestational age
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.	Throughout pregnancy (up to 42 weeks) and birth, including hospital admission in which birth took place (up to 7 days).

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Patti Janssen, PhD, University of British Columbia

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 2, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: mobile health; mental health; text messaging; perinatal outcomes; health behaviour; prenatal education
• Other Study ID Numbers: H22-00603

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: At completion of study enrollment for five years
• IPD Sharing Access Criteria: Available to academic researchers who have submitted a research protocol that has been approved by a university ethics board.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No