Healthy Moms for Healthy Babies (HealthyMoms)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03884803|
Recruitment Status : Active, not recruiting
First Posted : March 21, 2019
Last Update Posted : September 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Mental Health||Behavioral: E-health website Other: Standard Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Healthy Moms for Healthy Babies: Implementation of an Enhanced E-Health Prenatal Program to Promote Maternal Mental Health|
|Actual Study Start Date :||April 8, 2019|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
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)
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
- 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
- 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.
- 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)
- 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)
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884803
|McGill University Health Center|
|Montreal, Quebec, Canada|