Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE March 15, 2019
First Posted Date  ICMJE March 21, 2019
Last Update Posted Date September 10, 2020
Actual Study Start Date  ICMJE April 8, 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healthy Moms for Healthy Babies
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Mental Health
Intervention  ICMJE
  • Behavioral: E-health website
    Access to the e-health intervention (website)
  • Other: Standard Care
    Control group to continue with standard care
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 19, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03884803
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Deborah Da Costa, McGill University
Study Sponsor  ICMJE McGill University
Collaborators  ICMJE Medtech-Fonds de soutien à l'innovation en santé et en services sociaux (FSISSS)
Investigators  ICMJE Not Provided
PRS Account McGill University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP