Healthy Moms for Healthy Babies

Mental Health Clinical Trial

— HealthyMoms  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03884803
• Other study ID #: MP-37-2019-5119
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: May 2021

Study information

• Verified date: September 2020
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health

Intervention

Behavioral:
• E-health website
Access to the e-health intervention (website)

Other:
• Standard Care
Control group to continue with standard care

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montreal	Quebec

Sponsors (2)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of healthymoms website	Determine the acceptability of the program in terms of uptake, adherence, and user satisfaction. To use the Satisfaction and Usability survey	6 weeks post intervention
Primary	Change from baseline on depressed mood	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.	study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery
Secondary	Changes from baseline on pregnancy related anxiety	Evaluate changes in pregnancy related anxiety in order to evaluate the efficacy of the healthymoms website. Using the Pregnancy-related Anxiety questionnaire-revised (PRAQ-R)	study entry, 6 weeks post intervention
Secondary	Changes from baseline in physical activity	Evaluate 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)	study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery
Secondary	Changes from baseline on sleep quality	Evaluate 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	study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery
Secondary	Changes from baseline regarding satisfaction with antenatal care	Evaluate the changes in satisfaction with antenatal care in order to inform future implementation of the healthymoms website	study entry, 6 weeks post intervention