BC Children's Hospital Research Institute
Vancouver, British Columbia, Canada
Location status: Recruiting
NCT Number: NCT05793944
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.
Interested in participating?
Request Info15 year and older
Female
Interventional
Not applicable
Vancouver, British Columbia, Canada
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
University of British Columbia
Other
Teaching by Texting to Promote Health Behaviours in Pregnancy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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