Healthy Moms for Healthy Babies (HealthyMoms)
September 9, 2020 updated by: Deborah Da Costa, McGill University
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada
- McGill University Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
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. .
|
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.
|
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
Time Frame: 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
|
6 weeks post intervention
|
|
Change from baseline on depressed mood
Time Frame: 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.
|
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
Time Frame: 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)
|
study entry, 6 weeks post intervention
|
|
Changes from baseline in physical activity
Time Frame: 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)
|
study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery
|
|
Changes from baseline on sleep quality
Time Frame: 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
|
study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery
|
|
Changes from baseline regarding satisfaction with antenatal care
Time Frame: study entry, 6 weeks post intervention
|
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
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.