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Healthy Moms for Healthy Babies

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03884803
Acronym
HealthyMoms
Enrollment
120
Registered
2019-03-21
Start date
2019-04-08
Completion date
2021-05-31
Last updated
2020-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health

Brief summary

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.

Interventions

Access to the e-health intervention (website)

OTHERStandard Care

Control group to continue with standard care

Sponsors

Medtech-Fonds de soutien à l'innovation en santé et en services sociaux (FSISSS)
CollaboratorUNKNOWN
McGill University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Do not meet inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of healthymoms website6 weeks post interventionDetermine 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 moodstudy entry, 6 weeks post intervention, 3 months post delivery, 6 months post deliveryEstimate 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.

Secondary

MeasureTime frameDescription
Changes from baseline on pregnancy related anxietystudy entry, 6 weeks post interventionEvaluate changes in pregnancy related anxiety in order to evaluate the efficacy of the healthymoms website. Using the Pregnancy-related Anxiety questionnaire-revised (PRAQ-R)
Changes from baseline in physical activitystudy entry, 6 weeks post intervention, 3 months post delivery, 6 months post deliveryEvaluate changes in a health behaviour (physical activity) in order to evaluate the efficacy of the healthymoms website. Use of the International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Changes from baseline on sleep qualitystudy entry, 6 weeks post intervention, 3 months post delivery, 6 months post deliveryEvaluate changes in a health behaviour (sleep quality) in order to evaluate the efficacy of the healthymoms website. Use of the Pittsburgh Sleep Quality Index-short
Changes from baseline regarding satisfaction with antenatal carestudy entry, 6 weeks post interventionEvaluate the changes in satisfaction with antenatal care in order to inform future implementation of the healthymoms website

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026