SmartMom: Teaching by Texting to Promote Health Behaviours in Pregnancy

Study Overview
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Brief Summary
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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.

Official Title
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Teaching by Texting to Promote Health Behaviours in Pregnancy

Conditions
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Pregnancy

Intervention / Treatment
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* Behavioral: SmartMom text messaging
* Behavioral: Control text messaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 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 | 
| 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 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 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 | 
| 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prenatal education, perinatal outcomes, text messaging, mobile health, mental health, health behaviour