Clinical trial NCT06783387: Physical Activity, Mediterranean Diet and Maternity Blues: a Multidisciplinary Approach
Official title: Physical Activity, Mediterranean Diet and Maternity Blues: a Multidisciplinary Approach
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Maternity Blues
Keywords: maternity blues
Physical activity
multidisciplinary approach
Mediterranean diet
Lead sponsor: Centro Universitario Ricerca Interdipartimentale Attivita' Motoria
Sponsor class: OTHER
Collaborators: name: Sezione di Psichiatria Psicologia Clinica e Riabilitazione del Dipartimento di Medicina e Chirurgia dell'Università degli Studi di Perugia
name: Scuola di Specializzazione in Ginecologia ed Ostetricia del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia.
name: Sezione di Clinica Ostetrica e Ginecologia del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia
name: Clinica Ostetrica Ginecologica dell'Università degli Studi di Palermo
name: Scuola di Specializzazione in Psichiatria del Dipartimento di Medicina dell'Università degli Studi di Perugia
name: Centro Universitario Ricerca Interdipartimentale Attivita' Motoria del Dipartimento di Medicina dell''Università degli Studi di Perugia
First posted: 2025-01-20
Enrollment: 544
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Female subjects, aged ≥18 years and with adequate knowledge of spoken and written Italian.

Exclusion Criteria:

* Presence of pathologies that contraindicate the practice of physical activity.

Primary outcomes:
measure: Physical Activity Levels and sedentary time
timeFrame: From the moment of enlistment and within the first 10 days after giving birth
measure: Mediterranean Diet Adherence
timeFrame: From the moment of enlistment and within the first 10 days after giving birth
measure: Presence of symptoms of maternity blues
timeFrame: From the moment of enlistment and within the first 10 days after giving birth
measure: Date of birth
timeFrame: The questionnaire will be proposed within the first 10 days after giving birth
Secondary outcomes:
measure: City of birth
timeFrame: At the moment of enlistment
measure: Degree
timeFrame: From the moment of enlistment
measure: Marital status
timeFrame: At the moment of enlistment
measure: Age
timeFrame: At the moment of enlistment
measure: Weight before pregnancy
timeFrame: before pregnancy
measure: Weight at the moment of enlistment
timeFrame: At the moment of enlistment
measure: height
timeFrame: At the moment of enlistment
Other outcomes:
measure: Information about pregnancy and state of health
timeFrame: At the moment of enlistment
Locations:
city: Perugia
country: Italy
facility: Centro Universitario Ricerca Interdipartimentale Attivita' Motoria del Dipartimento di Medicina dell''Università degli Studi di Perugia
city: Perugia
country: Italy
facility: Clinica Ostetrica e Ginecologica dell' Azienda Ospedaliera di Perugia
city: Perugia
country: Italy
facility: Scuola di Specializzazione in Ginecologia ed Ostetricia del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia
city: Perugia
country: Italy
facility: Scuola di Specializzazione in Psichiatria del Dipartimento di Medicina dell'Università degli Studi di Perugia
city: Perugia
country: Italy
facility: Sezione di Psichiatria, Psicologia Clinica e Riabilitazione Psichiatrica del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia.
Study officials:
affiliation: Sezione di Clinica Ostetrica e Ginecologia del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia
name: Alessandro Favilli
role: PRINCIPAL_INVESTIGATOR
affiliation: Sezione di Psichiatria Psicologia Clinica e Riabilitazione del Dipartimento di Medicina e Chirurgia dell'Università degli Studi di Perugia
name: Giulia Menculini
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Universitario Ricerca Interdipartimentale Attivita' Motoria del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia
name: Roberto Pippi
role: PRINCIPAL_INVESTIGATOR
References: