Healthy Moms for Healthy Babies

NCT03884803 | Unknown

• 1 other identifier: MP-37-2019-5119
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health

Outcome Measures

Primary Outcomes (2)

• Acceptability of healthymoms website

  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

  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 Outcomes (4)

• Changes from baseline on pregnancy related anxiety

  study entry, 6 weeks post intervention

• Changes from baseline in physical activity

  study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery

• Changes from baseline on sleep quality

  study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery

• Changes from baseline regarding satisfaction with antenatal care

  study entry, 6 weeks post intervention

Study Arms (2)

HealthyMoms web-based program

OTHER

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

Control group

OTHER

No access to the intervention but to continue with standard care. Will complete the same questionnaires as the HealthyMoms group.

Other: Standard Care

Interventions

E-health website BEHAVIORAL

Access to the e-health intervention (website)

HealthyMoms web-based program

Standard Care OTHER

Control group to continue with standard care

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to communicate in French or English
• At least 18 years of age
• First child
• Internet and email access

Sponsors & Collaborators

• McGill University: lead
• Medtech-Fonds de soutien à l'innovation en santé et en services sociaux (FSISSS): collaborator

Study Sites (1)

McGill University Health Center

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 21, 2019
• Study Start: April 8, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

CA (1)