Mental HealthHealthyMomsNCT03884803
Healthy Moms for Healthy Babies
A study testing E-health website in people with Mental Health, run by McGill University at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- E-health website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 8 Apr 2019to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to communicate in French or English
- At least 18 years of age
- First child
- Internet and email access
Who cannot join
- Do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthy Moms for Healthy Babies: Implementation of an Enhanced E-Health Prenatal Program to Promote Maternal Mental Health
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
- Being tested
- E-health website, Standard Care
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-health websiteBehavioural
Access to the e-health intervention (website)
Standard CareOther
Control group to continue with standard care
| Study group | Role | What they receive |
|---|---|---|
| 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. . Receives: 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. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: study entry, 6 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start8 Apr 2019
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtech-Fonds de soutien à l'innovation en santé et en services sociaux (FSISSS)
- Responsible party
- Principal investigator, Deborah Da Costa, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884803
- Sponsor's protocol ID
- MP-37-2019-5119
- Acronym
- HealthyMoms
- Status last verified
- Sep 2020
- First submitted
- 15 Mar 2019
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Moms for Healthy Babies: Implementation of an Enhanced E-Health Prenatal Program to Promote Maternal Mental Health
- ClinicalTrials.gov ID
- NCT03884803
- Acronym / sponsor ID
- HealthyMoms / MP-37-2019-5119
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Medtech-Fonds de soutien à l'innovation en santé et en services sociaux (FSISSS)
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HealthyMoms web-based program | Other | Behavioral: E-health websiteAn on-line self-help psychoeducational website for new moms that includes educational learning modules and tools to prevent/reduce depression. . |
| Control group | Other | Other: Standard CareNo access to the intervention but to continue with standard care. Will complete the same questionnaires as the HealthyMoms group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to communicate in French or English
- At least 18 years of age
- First child
- Internet and email access
Key exclusion criteria (1 listed)
- Do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-health websiteAccess to the e-health intervention (website) | Behavioural | HealthyMoms web-based program |
| Standard CareControl group to continue with standard care | Other | Control group |
Primary outcome
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.
4 secondary outcomes
Changes from baseline on pregnancy related anxiety
Time frame: study entry, 6 weeks post intervention
Changes from baseline in physical activity
Time frame: study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery
Changes from baseline on sleep quality
Time frame: study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery
Changes from baseline regarding satisfaction with antenatal care
Time frame: study entry, 6 weeks post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-health website in people with Mental Health, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of healthymoms website (time frame: 6 weeks post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.