Healthy Moms for Healthy Babies (HealthyMoms)

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

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.

Study Overview

• Status: Unknown
• Conditions: Mental Health
• Intervention / Treatment: Behavioral: E-health website; Other: Standard Care

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • McGill University Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: HealthyMoms web-based program; An on-line self-help psychoeducational website for new moms that includes educational learning modules and tools to prevent/reduce depression. .	Behavioral: E-health website; Access to the e-health intervention (website)
OTHER: Control group; No access to the intervention but to continue with standard care. Will complete the same questionnaires as the HealthyMoms group.	Other: Standard Care; Control group to continue with standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 8, 2019
• Primary Completion (ANTICIPATED): May 1, 2021
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (ACTUAL): March 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MP-37-2019-5119

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No