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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
Sponsor:
Collaborator:
Medtech-Fonds de soutien à l'innovation en santé et en services sociaux (FSISSS)
Information provided by (Responsible Party):
Deborah Da Costa, 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.

Condition or disease Intervention/treatment Phase
Mental Health Behavioral: E-health website Other: Standard Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
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)

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




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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Canada, Quebec
McGill University Health Center
Montreal, Quebec, Canada
Sponsors and Collaborators
McGill University
Medtech-Fonds de soutien à l'innovation en santé et en services sociaux (FSISSS)
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Responsible Party: Deborah Da Costa, Associate Professor, McGill University
ClinicalTrials.gov Identifier: NCT03884803    
Other Study ID Numbers: MP-37-2019-5119
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No