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NCT Number: NCT06783387

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

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.

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Key information

Conditions

Maternity Blues Behavior Motor Activity

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Date of birth

    Time frame: The questionnaire will be proposed within the first 10 days after giving birth

    Number of days since giving birth

Secondary outcomes

  1. City of birth

    Time frame: At the moment of enlistment

    indicate in which city you gave birth

  2. Degree

    Time frame: 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

  3. Marital status

    Time frame: At the moment of enlistment

    Marital status, choosing from:

    • Single.
    • Cohabiting/Married.
    • Separated/Divorced.
    • Widow.

  4. Age

    Time frame: At the moment of enlistment

    Age, in years

  5. Weight before pregnancy

    Time frame: before pregnancy

    Weight in kilograms

  6. Weight at the moment of enlistment

    Time frame: At the moment of enlistment

    Weight in kilograms

  7. height

    Time frame: At the moment of enlistment

    height in meters

Other outcomes

  1. Information about pregnancy and state of health

    Time frame: At the moment of enlistment

    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...)

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Favilli

CONTACT

[email protected]

+390755783231

Roberto Pippi

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centro Universitario Ricerca Interdipartimentale Attivita' Motoria

Other

Collaborators

  • Centro Universitario Ricerca Interdipartimentale Attivita' Motoria del Dipartimento di Medicina dell''Università degli Studi di Perugia
  • Clinica Ostetrica Ginecologica dell'Università degli Studi di Palermo
  • Scuola di Specializzazione in Ginecologia ed Ostetricia del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia.
  • Scuola di Specializzazione in Psichiatria del Dipartimento di Medicina dell'Università degli Studi di Perugia
  • Sezione di Clinica Ostetrica e Ginecologia del Dipartimento di Medicina e Chirurgia dell' Università degli Studi di Perugia
  • Sezione di Psichiatria Psicologia Clinica e Riabilitazione del Dipartimento di Medicina e Chirurgia dell'Università degli Studi di Perugia

Registry information

Acronym: MMB/01

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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