NCT06783387

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
544

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2025

Geographic Reach
1 country

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

December 12, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

1.9 years

First QC Date

December 12, 2024

Last Update Submit

January 17, 2025

Conditions

Maternity Blues

Keywords

maternity bluesPhysical activitymultidisciplinary approachMediterranean diet

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • City of birth

    At the moment of enlistment

  • Degree

    From the moment of enlistment

  • Marital status

    At the moment of enlistment

  • Age

    At the moment of enlistment

  • Weight before pregnancy

    before pregnancy

  • +2 more secondary outcomes

Other Outcomes (1)

  • Information about pregnancy and state of health

    At the moment of enlistment

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centro Universitario Ricerca Interdipartimentale Attivita' Motoria del Dipartimento di Medicina dell''Università degli Studi di Perugia

Perugia, Italy, 06126, Italy

Location

Clinica Ostetrica e Ginecologica dell' Azienda Ospedaliera di Perugia

Perugia, Italy, 06129, Italy

Location

Scuola di Specializzazione in Ginecologia ed Ostetricia del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia

Perugia, Italy, 06129, Italy

Location

Scuola di Specializzazione in Psichiatria del Dipartimento di Medicina dell'Università degli Studi di Perugia

Perugia, Italy, 06129, Italy

Location

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

Perugia, Italy, 06129, Italy

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Favilli

CONTACT

+390755783231alessandro.favilli@unipg.it

Roberto Pippi

CONTACT

roberto.pippi@unipg.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2024

First Posted

January 20, 2025

Study Start

January 15, 2025

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

IT(5)