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临床试验/NCT03884803
NCT03884803Unknown不适用

Healthy Moms for Healthy Babies: Implementation of an Enhanced E-Health Prenatal Program to Promote Maternal Mental Health

McGill University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年4月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Acceptability of healthymoms website

研究概览

简要总结

HealthyMoms is prototype website with accurate and easily accessible information on the impact of depression, anxiety and stress during pregnancy and the importance of healthy behaviours (physical activity, nutrition, sleep). This clinical trial is to pilot test the implementation of the e-health intervention alongside standard antenatal care.

研究设计

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

入排标准

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

入选标准

  • •Able to communicate in French or English
  • •At least 18 years of age
  • •First child
  • •Internet and email access

排除标准

  • •Do not meet inclusion criteria

研究组 & 干预措施

HealthyMoms web-based program

Other

An on-line self-help psychoeducational website for new moms that includes educational learning modules and tools to prevent/reduce depression. .

干预措施: E-health website (Behavioral)

Control group

Other

No access to the intervention but to continue with standard care. Will complete the same questionnaires as the HealthyMoms group.

干预措施: Standard Care (Other)

结局指标

主要结局

Acceptability of healthymoms website

时间窗: 6 weeks post intervention

Determine the acceptability of the program in terms of uptake, adherence, and user satisfaction. To use the Satisfaction and Usability survey

Change from baseline on depressed mood

时间窗: study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery

Estimate the range of effect sizes for depressive symptoms in order to evaluate the efficacy of the program (healthymoms website). Measured by the Edinburgh Postnatal Depression Scale.

次要结局

  • Changes from baseline on sleep quality(study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery)
  • Changes from baseline on pregnancy related anxiety(study entry, 6 weeks post intervention)
  • Changes from baseline regarding satisfaction with antenatal care(study entry, 6 weeks post intervention)
  • Changes from baseline in physical activity(study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery)

研究者

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

Deborah Da Costa

Associate Professor

McGill University

研究点 (1)

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