Clinical trial NCT05793944: SmartMom: Teaching by Texting to Promote Health Behaviours in Pregnancy
Official title: Teaching by Texting to Promote Health Behaviours in Pregnancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Keywords: prenatal education
perinatal outcomes
text messaging
mobile health
mental health
health behaviour
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-03-31
Enrollment: 3078
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in weight during pregnancy
timeFrame: Enrollment, 38 weeks gestation
measure: Attendance at prenatal care visits through pregnancy
timeFrame: 38 weeks gestation
Secondary outcomes:
measure: Changes in health knowledge through pregnancy
timeFrame: Enrollment, 38 weeks gestation
measure: Health literacy at end of pregnancy
timeFrame: 38 weeks gestation
measure: Changes in fear of childbirth through pregnancy
timeFrame: Enrollment, 38 weeks gestational age
measure: Changes in depression through pregnancy
timeFrame: Enrollment, 38 weeks gestational age
measure: Changes in anxiety through pregnancy
timeFrame: Enrollment, 38 weeks gestational age
measure: Changes in use of tobacco, vaping, alcohol, or cannabis through pregnancy among users.
timeFrame: Enrollment, 38 weeks gestational age
measure: Rates of planned vaginal birth after cesarean
timeFrame: 38 weeks gestation
measure: Rates of exclusive breastfeeding at hospital discharge
timeFrame: 1 month post birth
measure: 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.
timeFrame: 1 month post birth
measure: Incremental costs per incidence of suboptimal weight gain and inadequate prenatal care avoided.
timeFrame: Throughout pregnancy (up to 42 weeks) and birth, including hospital admission in which birth took place (up to 7 days).
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital Research Institute
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Patti Janssen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.