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Not yet recruiting NCT06783387

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

Observational Maternity Blues

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Maternity Blues. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Physical Activity Levels and sedentary time [Time frame: From the moment of enlistment and within the first 10 days after giving birth]
  • Mediterranean Diet Adherence [Time frame: From the moment of enlistment and within the first 10 days after giving birth]
  • Presence of symptoms of maternity blues [Time frame: From the moment of enlistment and within the first 10 days after giving birth]
  • Date of birth [Time frame: The questionnaire will be proposed within the first 10 days after giving birth]
Secondary outcome measures (7)
  • City of birth [Time frame: At the moment of enlistment]
  • Degree [Time frame: From the moment of enlistment]
  • Marital status [Time frame: At the moment of enlistment]
  • Age [Time frame: At the moment of enlistment]
  • Weight before pregnancy [Time frame: before pregnancy]
  • Weight at the moment of enlistment [Time frame: At the moment of enlistment]
  • height [Time frame: At the moment of enlistment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Italy · 5 centers
  • Centro Universitario Ricerca Interdipartimentale Attivita' Motoria del Dipartimento di Med — Perugia
  • Clinica Ostetrica e Ginecologica dell' Azienda Ospedaliera di Perugia — Perugia
  • Scuola di Specializzazione in Ginecologia ed Ostetricia del Dipartimento di Medicina e Chi — Perugia
  • Scuola di Specializzazione in Psichiatria del Dipartimento di Medicina dell'Università deg — Perugia
  • Sezione di Psichiatria, Psicologia Clinica e Riabilitazione Psichiatrica del Dipartimento — Perugia

Identifiers

NCT: NCT06783387 · CURicerca

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗