Healthy Moms for Healthy Babies

Not Applicable

• Conditions: Mental Health
• Interventions: Behavioral: E-health website; Other: Standard Care

• Registration Number: NCT03884803
• Lead Sponsor: McGill University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-21
• Study Start: 2019-04-08
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-10
• Primary Completion: 2021-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HealthyMoms web-based program	E-health website	An on-line self-help psychoeducational website for new moms that includes educational learning modules and tools to prevent/reduce depression. .
Control group	Standard Care	No access to the intervention but to continue with standard care. Will complete the same questionnaires as the HealthyMoms group.

Primary Outcome Measures

Name	Time	Method
Acceptability of healthymoms website	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	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.

Secondary Outcome Measures

Name	Time	Method
Changes from baseline on pregnancy related anxiety	study entry, 6 weeks post intervention	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)
Changes from baseline on sleep quality	study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery	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
Changes from baseline regarding satisfaction with antenatal care	study entry, 6 weeks post intervention	Evaluate the changes in satisfaction with antenatal care in order to inform future implementation of the healthymoms website
Changes from baseline in physical activity	study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery	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)

Trial Locations

Locations (1)

McGill University Health Center; 🇨🇦 Montreal, Quebec, Canada