Healthy Moms for Healthy Babies (HealthyMoms)

• ClinicalTrials.gov Identifier: NCT03884803
• Recruitment Status: Active, not recruiting
• First Posted: March 21, 2019
• Last Update Posted: September 10, 2020
• Sponsor: McGill University
• 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

Tracking Information

• First Submitted Date: March 15, 2019
• First Posted Date: March 21, 2019
• Last Update Posted Date: September 10, 2020
• Actual Study Start Date: April 8, 2019
• Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 19, 2019)

• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 19, 2019)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Healthy Moms for Healthy Babies
• Official Title: Healthy Moms for Healthy Babies: Implementation of an Enhanced E-Health Prenatal Program to Promote Maternal Mental Health
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Mental Health

Intervention

• Behavioral: E-health website
  Access to the e-health intervention (website)
• Other: Standard Care
  Control group to continue with standard care

Study Arms

• 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. .
  Intervention: Behavioral: E-health website
• Control group
  No access to the intervention but to continue with standard care. Will complete the same questionnaires as the HealthyMoms group.
  Intervention: Other: Standard Care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: March 19, 2019): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2021
• Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03884803
• Other Study ID Numbers: MP-37-2019-5119
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Responsible Party: Deborah Da Costa, McGill University
• Study Sponsor: McGill University
• Collaborators: Medtech-Fonds de soutien à l'innovation en santé et en services sociaux (FSISSS)
• Investigators: Not Provided
• PRS Account: McGill University
• Verification Date: September 2020