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临床试验/NCT05793944
NCT05793944招募中不适用

Teaching by Texting to Promote Health Behaviours in Pregnancy

University of British Columbia1 个研究点 分布在 1 个国家目标入组 3,078 人开始时间: 2023年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
3,078
试验地点
1
主要终点
Change in weight during pregnancy

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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)

排除标准

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

研究组 & 干预措施

Intervention: SmartMom messaging

Active Comparator

Participants receive three text messages per week with evidence-based information to promote healthy behaviours during pregnancy.

干预措施: SmartMom text messaging (Behavioral)

Control messaging

Placebo Comparator

Participants receive one text message per week with general information about pregnancy but not about making healthy choices.

干预措施: Control text messaging (Behavioral)

结局指标

主要结局

Change in weight during pregnancy

时间窗: 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

时间窗: 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.

次要结局

  • Changes in health knowledge through pregnancy(Enrollment, 38 weeks gestation)
  • Health literacy at end of pregnancy(38 weeks gestation)
  • Changes in fear of childbirth through pregnancy(Enrollment, 38 weeks gestational age)
  • Changes in anxiety through pregnancy(Enrollment, 38 weeks gestational age)
  • Changes in use of tobacco, vaping, alcohol, or cannabis through pregnancy among users.(Enrollment, 38 weeks gestational age)
  • Changes in depression through pregnancy(Enrollment, 38 weeks gestational age)
  • Rates of planned vaginal birth after cesarean(38 weeks gestation)
  • Rates of exclusive breastfeeding at hospital discharge(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.(1 month post birth)
  • 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).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia Janssen

Professor

University of British Columbia

研究点 (1)

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