Physical Activity, Mediterranean Diet and Maternity Blues: a Multidisciplinary Approach (MMB/01)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Maternity Blues

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 Type: Observational
• Enrollment (Estimated): 544

Contacts and Locations

• Study Contact: Name: Alessandro Favilli; Phone Number: +390755783231; Email: alessandro.favilli@unipg.it
• Study Contact Backup: Name: Roberto Pippi; Email: roberto.pippi@unipg.it

Study Locations

• Italy
  • Perugia, Italy, 06126
    • Centro Universitario Ricerca Interdipartimentale Attivita' Motoria del Dipartimento di Medicina dell''Università degli Studi di Perugia
    • Contact: Roberto Pippi; Email: roberto.pippi@unipg.itR
    • Contact: Roberto Pippi
    • Contact: Carmine G Fanelli
  • Perugia, Italy, 06129
    • Clinica Ostetrica e Ginecologica dell' Azienda Ospedaliera di Perugia
    • Contact: Alessandro Favilli; Phone Number: +390755783231; Email: alessandro.favilli@unipg.it
    • Contact: Alessandro Favilli
    • Contact: Sandro Gerli, Prof.
  • Perugia, Italy, 06129
    • Scuola di Specializzazione in Ginecologia ed Ostetricia del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia
    • Contact: Sandro Gerli, Prof.; Email: sandro.gerli@unipg.it
    • Contact: Giovanna Rondini
  • Perugia, Italy, 06129
    • Scuola di Specializzazione in Psichiatria del Dipartimento di Medicina dell'Università degli Studi di Perugia
    • Contact: Alfonso Tortorella, Prof.; Email: alfonso.tortorella@unipg.it
    • Contact: Agnese Minuti
  • Perugia, Italy, 06129
    • Sezione di Psichiatria, Psicologia Clinica e Riabilitazione Psichiatrica del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia.
    • Contact: Giulia Menculini; Email: giulia.menculini@unipg.it
    • Contact: Giulia Menculini
    • Contact: Alfonso Tortorella, Prof.
    • Contact: Alessandra Vestri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Levels and sedentary time	Physical Activity Levels and sedentary time data will be collected using the l'International Physical Activity Questionnaire	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	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	From the moment of enlistment and within the first 10 days after giving birth
Date of birth	Number of days since giving birth	The questionnaire will be proposed within the first 10 days after giving birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
City of birth	indicate in which city you gave birth	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	From the moment of enlistment
Marital status	Marital status, choosing from: Single.; Cohabiting/Married.; Separated/Divorced.; Widow.	At the moment of enlistment
Age	Age, in years	At the moment of enlistment
Weight before pregnancy	Weight in kilograms	before pregnancy
Weight at the moment of enlistment	Weight in kilograms	At the moment of enlistment
height	height in meters	At the moment of enlistment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Information about pregnancy and state of health	Some closed questions were proposed to ask the participants if they had other pregnancies before this one (operative births, spontaneous births, spontaneous abortions, etc...); if they had previously suffered from Postpartum Depression Maternity blues Postpartum psychosis, and if during this pregnancy one or more pathologies were diagnosed (for example Gestational Diabetes, Gestational Hypertension, etc...)	At the moment of enlistment

Collaborators and Investigators

• Sponsor: Centro Universitario Ricerca Interdipartimentale Attivita' Motoria
• 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
• Investigators: Principal Investigator: Alessandro Favilli, Sezione di Clinica Ostetrica e Ginecologia del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia; Principal Investigator: Giulia Menculini, Sezione di Psichiatria Psicologia Clinica e Riabilitazione del Dipartimento di Medicina e Chirurgia dell'Università degli Studi di Perugia; Principal Investigator: Roberto Pippi, Centro Universitario Ricerca Interdipartimentale Attivita' Motoria del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Physical activity; Mediterranean diet; multidisciplinary approach; maternity blues
• Other Study ID Numbers: CURicerca

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No