Maternity BluesMMB/01NCT06783387
Physical Activity, Mediterranean Diet and Maternity Blues: a Multidisciplinary Approach
An observational study of Maternity Blues, run by Centro Universitario Ricerca Interdipartimentale Attivita' Motoria at 5 sites in Italy.
Trial summary
This study aims to evaluate the levels of physical activity, sedentary time, eating habits, and emotional well-being in a group of women after giving birth. 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
- Maternity Blues
- How many people
- 544 participants
- Where
- 5 sitesItaly
- Study dates
- 15 Jan 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Puerperal women within three days of giving birth who decide to participate, voluntarily, autonomously and anonymously, in the survey via an online questionnaire, according to non-probability convenience sampling.
Who may be able to join
- Female subjects, aged ≥18 years and with adequate knowledge of spoken and written Italian.
Who cannot join
- Presence of pathologies that contraindicate the practice of physical activity.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Roberto Pippi contact
5 sites in 1 country
Italy5 sites
Centro Universitario Ricerca Interdipartimentale Attivita' Motoria del Dipartimento di Medicina dell''Università degli Studi di Perugia
Perugia, Italy, 06126
Roberto Pippi, roberto.pippi@unipg.itR
Roberto Pippi
Clinica Ostetrica e Ginecologica dell' Azienda Ospedaliera di Perugia
Perugia, Italy, 06129
Alessandro Favilli, +390755783231, alessandro.favilli@unipg.it
Alessandro Favilli
Scuola di Specializzazione in Ginecologia ed Ostetricia del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia
Perugia, Italy, 06129
Sandro Gerli, Prof., sandro.gerli@unipg.it
Giovanna Rondini
Scuola di Specializzazione in Psichiatria del Dipartimento di Medicina dell'Università degli Studi di Perugia
Perugia, Italy, 06129
Alfonso Tortorella, Prof., alfonso.tortorella@unipg.it
Agnese Minuti
Sezione di Psichiatria, Psicologia Clinica e Riabilitazione Psichiatrica del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia.
Perugia, Italy, 06129
Giulia Menculini, giulia.menculini@unipg.it
Giulia Menculini
About this study
This study aims to evaluate the levels of physical activity, sedentary time, eating habits, and emotional well-being in a group of women after giving birth.
Read the detailed description
The study involves the enrollment of 544 subjects and the overall expected duration is 24 months.
The study is observational, as it only involves collecting and recording information and clinical data according to the times and methods of treatment to which women are subjected in normal hospital practice.
In particular, the collection of information about:
- general nature;
- the pregnancy;
- participants' levels of physical activity and sedentary lifestyle;
- participants' nutritional habits;
- factors that influence participants' emotional well-being. The data will be collected in digital format, through filling out an online questionnaire. The data obtained will be organized in a digital file and processed in aggregate and anonymous form. Access to the data will be permitted only to personnel authorized for the study.
- Conditions
- Maternity Blues
- Keywords
- maternity blues, Physical activity, multidisciplinary approach, Mediterranean diet
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| New mothers | 544 women who have recently given birth in one of the Clinics involved in the study will be invited to respond to an online questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Levels and sedentary time
Physical Activity Levels and sedentary time data will be collected using the l'International Physical Activity Questionnaire
Measured: From the moment of enlistment and within the first 10 days after giving birth
Mediterranean Diet Adherence
Mediterranean Diet Adherence data will be collected using the 14-item Mediterranean diet assessment tool
Measured: From the moment of enlistment and within the first 10 days after giving birth
Presence of symptoms of maternity blues
These data will be collected using the Edinburgh Postnatal Depression Scale
Measured: From the moment of enlistment and within the first 10 days after giving birth
Date of birth
Number of days since giving birth
Measured: The questionnaire will be proposed within the first 10 days after giving birth
Secondary outcomes (7)
City of birth
indicate in which city you gave birth
Measured: At the moment of enlistment
Degree
Degree (choose from):
- Primary school
- Middle school (or lower secondary school)
- Secondary school (or upper secondary school)
- Bachelor's degree
- PhD/Specialization
Measured: From the moment of enlistment
Marital status
Marital status, choosing from:
- Single.
- Cohabiting/Married.
- Separated/Divorced.
- Widow.
Measured: At the moment of enlistment
Age
Age, in years
Measured: At the moment of enlistment
Weight before pregnancy
Weight in kilograms
Measured: before pregnancy
Weight at the moment of enlistment
Weight in kilograms
Measured: At the moment of enlistment
height
height in meters
Measured: At the moment of enlistment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternity BluesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 544 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitario Ricerca Interdipartimentale Attivita' Motoria
- Sponsor type
- University, hospital or other
- Collaborators
- Sezione di Psichiatria Psicologia Clinica e Riabilitazione del Dipartimento di Medicina e Chirurgia dell'Università degli Studi di Perugia, Scuola di Specializzazione in Ginecologia ed Ostetricia del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia., Sezione di Clinica Ostetrica e Ginecologia del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia, Clinica Ostetrica Ginecologica dell'Università degli Studi di Palermo, Scuola di Specializzazione in Psichiatria del Dipartimento di Medicina dell'Università degli Studi di Perugia, Centro Universitario Ricerca Interdipartimentale Attivita' Motoria del Dipartimento di Medicina dell''Università degli Studi di Perugia
- Responsible party
- Sponsor
- Investigators
- Alessandro Favilli, Principal investigator, Sezione di Clinica Ostetrica e Ginecologia del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di PerugiaGiulia Menculini, Principal investigator, Sezione di Psichiatria Psicologia Clinica e Riabilitazione del Dipartimento di Medicina e Chirurgia dell'Università degli Studi di PerugiaRoberto Pippi, Principal investigator, Centro Universitario Ricerca Interdipartimentale Attivita' Motoria del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783387
- Sponsor's protocol ID
- CURicerca
- Acronym
- MMB/01
- Status last verified
- Jan 2025
- First submitted
- 12 Dec 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Mediterranean Diet and Maternity Blues: a Multidisciplinary Approach
- ClinicalTrials.gov ID
- NCT06783387
- Acronym / sponsor ID
- MMB/01 / CURicerca
- Conditions
- Maternity Blues
- Keywords
- maternity blues, Physical activity, multidisciplinary approach, Mediterranean diet
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 544 participants (estimated)
- Lead sponsor
- Centro Universitario Ricerca Interdipartimentale Attivita' MotoriaUniversity, hospital or other
- Collaborators
- Sezione di Psichiatria Psicologia Clinica e Riabilitazione del Dipartimento di Medicina e Chirurgia dell'Università degli Studi di Perugia, Scuola di Specializzazione in Ginecologia ed Ostetricia del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia., Sezione di Clinica Ostetrica e Ginecologia del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia, Clinica Ostetrica Ginecologica dell'Università degli Studi di Palermo, Scuola di Specializzazione in Psichiatria del Dipartimento di Medicina dell'Università degli Studi di Perugia, Centro Universitario Ricerca Interdipartimentale Attivita' Motoria del Dipartimento di Medicina dell''Università degli Studi di Perugia
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 2025 (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.
This study aims to evaluate the levels of physical activity, sedentary time, eating habits, and emotional well-being in a group of women after giving birth.
Detailed description
The study involves the enrollment of 544 subjects and the overall expected duration is 24 months.
The study is observational, as it only involves collecting and recording information and clinical data according to the times and methods of treatment to which women are subjected in normal hospital practice.
In particular, the collection of information about:
- general nature;
- the pregnancy;
- participants' levels of physical activity and sedentary lifestyle;
- participants' nutritional habits;
- factors that influence participants' emotional well-being. The data will be collected in digital format, through filling out an online questionnaire. The data obtained will be organized in a digital file and processed in aggregate and anonymous form. Access to the data will be permitted only to personnel authorized for the study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New mothers | – | –544 women who have recently given birth in one of the Clinics involved in the study will be invited to respond to an online questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Puerperal women within three days of giving birth who decide to participate, voluntarily, autonomously and anonymously, in the survey via an online questionnaire, according to non-probability convenience sampling.
Key inclusion criteria (1 listed)
- Female subjects, aged ≥18 years and with adequate knowledge of spoken and written Italian.
Key exclusion criteria (1 listed)
- Presence of pathologies that contraindicate the practice of physical activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical Activity Levels and sedentary time
Time frame: From the moment of enlistment and within the first 10 days after giving birth
Physical Activity Levels and sedentary time data will be collected using the l'International Physical Activity Questionnaire
Mediterranean Diet Adherence
Time frame: From the moment of enlistment and within the first 10 days after giving birth
Mediterranean Diet Adherence data will be collected using the 14-item Mediterranean diet assessment tool
Presence of symptoms of maternity blues
Time frame: From the moment of enlistment and within the first 10 days after giving birth
These data will be collected using the Edinburgh Postnatal Depression Scale
Date of birth
Time frame: The questionnaire will be proposed within the first 10 days after giving birth
Number of days since giving birth
7 secondary outcomes
City of birth
Time frame: At the moment of enlistment
Degree
Time frame: From the moment of enlistment
Marital status
Time frame: At the moment of enlistment
Age
Time frame: At the moment of enlistment
Weight before pregnancy
Time frame: before pregnancy
Weight at the moment of enlistment
Time frame: At the moment of enlistment
height
Time frame: At the moment of enlistment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: Yes
Related trials for Maternity Blues
Active, not recruiting
An Intervention to Enhance Well-Being in Trauma Exposed New Mothers
Post-traumatic Stress Disorder, Dissociation
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.
Roberto Pippi contact
Alessandro Favilli principal investigator
Sezione di Clinica Ostetrica e Ginecologia del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia
Giulia Menculini principal investigator
Sezione di Psichiatria Psicologia Clinica e Riabilitazione del Dipartimento di Medicina e Chirurgia dell'Università degli Studi di Perugia
Roberto Pippi principal investigator
Centro Universitario Ricerca Interdipartimentale Attivita' Motoria del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternity Blues, run by Centro Universitario Ricerca Interdipartimentale Attivita' Motoria at 5 sites in Italy.
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 1 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: opening soon, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Favilli (+390755783231, alessandro.favilli@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Levels and sedentary time (time frame: From the moment of enlistment and within the first 10 days after giving birth). The study lists 4 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 20 Jan 2025.