Physical Activity, Mediterranean Diet and Maternity Blues: a Multidisciplinary Approach

Not yet recruiting

• Conditions: Maternity Blues

• Registration Number: NCT06783387
• Lead Sponsor: Centro Universitario Ricerca Interdipartimentale Attivita' Motoria

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.

Study Timeline

• Study First Submitted: 2024-12-12
• Status Verified: 2025-01
• Study Start: 2025-01-15
• Study First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20
• Primary Completion: 2026-12-15
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 544

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical Activity Levels and sedentary time	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	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	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	The questionnaire will be proposed within the first 10 days after giving birth	Number of days since giving birth

Secondary Outcome Measures

Name	Time	Method
Weight before pregnancy	before pregnancy	Weight in kilograms
Weight at the moment of enlistment	At the moment of enlistment	Weight in kilograms
height	At the moment of enlistment	height in meters
City of birth	At the moment of enlistment	indicate in which city you gave birth
Degree	From the moment of enlistment	Degree (choose from): * Primary school; * Middle school (or lower secondary school); * Secondary school (or upper secondary school); * Bachelor's degree; * PhD/Specialization
Marital status	At the moment of enlistment	Marital status, choosing from: * Single.; * Cohabiting/Married.; * Separated/Divorced.; * Widow.
Age	At the moment of enlistment	Age, in years

Trial Locations

Locations (5)

Centro Universitario Ricerca Interdipartimentale Attivita' Motoria del Dipartimento di Medicina dell''Università degli Studi di Perugia; 🇮🇹 Perugia, Italy

Clinica Ostetrica e Ginecologica dell' Azienda Ospedaliera di Perugia; 🇮🇹 Perugia, Italy

Scuola di Specializzazione in Ginecologia ed Ostetricia del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia; 🇮🇹 Perugia, Italy

Scuola di Specializzazione in Psichiatria del Dipartimento di Medicina dell'Università degli Studi di Perugia; 🇮🇹 Perugia, Italy

Sezione di Psichiatria, Psicologia Clinica e Riabilitazione Psichiatrica del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia.; 🇮🇹 Perugia, Italy