Pregnancy
Conditions
Keywords
prenatal education, perinatal outcomes, text messaging, mobile health, mental health, health behaviour
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. 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.
Interventions
BEHAVIORALSmartMom 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.
BEHAVIORALControl 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.
Sponsors
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight during pregnancy | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in health knowledge through pregnancy | Enrollment, 38 weeks gestation | 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. |
| Health literacy at end of pregnancy | 38 weeks gestation | 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. |
| Changes in fear of childbirth through pregnancy | Enrollment, 38 weeks gestational age | 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. |
| Changes in depression through pregnancy | Enrollment, 38 weeks gestational age | 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. |
| Changes in anxiety through pregnancy | Enrollment, 38 weeks gestational age | 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. |
| Changes in use of tobacco, vaping, alcohol, or cannabis through pregnancy among users. | Enrollment, 38 weeks gestational age | 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. |
| Rates of planned vaginal birth after cesarean | 38 weeks gestation | 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. |
| Rates of exclusive breastfeeding at hospital discharge | 1 month post 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. |
| 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. | 1 month post 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. |
| Incremental costs per incidence of suboptimal weight gain and inadequate prenatal care avoided. | Throughout pregnancy (up to 42 weeks) and birth, including hospital admission in which birth took place (up to 7 days). | 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. |
Countries
Canada
Contacts
CONTACTSara Leckie, MSc
CONTACTPatti Janssen, PhD
PRINCIPAL_INVESTIGATORPatti Janssen, PhD
University of British Columbia
Outcome results
None listed