Healthy Moms for Healthy Babies

Study Overview
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Brief Summary
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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.

Official Title
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Healthy Moms for Healthy Babies: Implementation of an Enhanced E-Health Prenatal Program to Promote Maternal Mental Health

Conditions
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Mental Health

Intervention / Treatment
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* Behavioral: E-health website
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HealthyMoms web-based program<br>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<br>* Access to the e-health intervention (website)<br>|
| Other: Control group<br>No access to the intervention but to continue with standard care. Will complete the same questionnaires as the HealthyMoms group. | Other: Standard Care<br>* Control group to continue with standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline on pregnancy related anxiety | 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) | study entry, 6 weeks post intervention | 
| Changes from baseline in physical activity | 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) | study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery | 
| Changes from baseline on sleep quality | 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 | study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery | 
| Changes from baseline regarding satisfaction with antenatal care | Evaluate the changes in satisfaction with antenatal care in order to inform future implementation of the healthymoms website | study entry, 6 weeks post intervention |