NCT06654674

Brief Summary

This study investigates gender differences in dietary patterns and physical activity using Principal Component Analysis (PCA). It aims to identify distinct eating and activity behaviors between men and women in order to develop gender-specific interventions that promote better metabolic health. The study was conducted at a metabolic health center in Rome, Italy, with 2,509 participants. Data were collected through questionnaires and body composition assessments, and PCA was applied to classify participants into groups based on their behaviors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,509

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

1.4 years

First QC Date

October 17, 2024

Last Update Submit

October 21, 2024

Conditions

Keywords

Gender DifferencesDietary PatternsPhysical ActivityPrincipal Component Analysis (PCA)Body CompositionMetabolic Health

Outcome Measures

Primary Outcomes (1)

  • Principal Component Analysis (PCA)

    The primary outcome is the identification of distinct dietary patterns and physical activity behaviors based on gender differences.

    Cross-sectional assessment at baseline

Secondary Outcomes (1)

  • Physical activity levels based on gender differences

    Cross-sectional assessment at baseline

Study Arms (1)

Study Participants

This group consists of 2,509 adult participants recruited from a metabolic health center in Rome, Italy. Data on dietary patterns, physical activity, and body composition were collected and analyzed using Principal Component Analysis (PCA) to identify trends and patterns related to gender differences in eating behaviors and physical activity. No specific intervention was applied, as this is an observational study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of 2,509 adults attending a metabolic health center in Rome, Italy. These participants were recruited between May 2023 and June 2024. The sample includes both men and women, with a focus on identifying gender-specific patterns in dietary behaviors, physical activity, and body composition. Participants underwent bioimpedance analysis and completed questionnaires regarding their eating habits and physical activity levels.

You may qualify if:

  • Adults aged 18 years or older.
  • Participants attending the metabolic health center in Rome, Italy.
  • Participants who provided informed consent.
  • Participants with complete data on dietary patterns, physical activity, and body composition.

You may not qualify if:

  • Individuals under 18 years of age.
  • Participants with diagnosed psychiatric disorders.
  • Pregnant women.
  • Participants with incomplete or inconsistent data.
  • Individuals with alcohol dependence.
  • Participants with significant medical conditions that could affect dietary or physical activity assessments (e.g., severe chronic illnesses).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Raffaele Open University

Roma, 00166, Italy

Location

Related Publications (3)

  • Alosaimi N, Sherar LB, Griffiths P, Pearson N. Clustering of diet, physical activity and sedentary behaviour and related physical and mental health outcomes: a systematic review. BMC Public Health. 2023 Aug 18;23(1):1572. doi: 10.1186/s12889-023-16372-6.

    PMID: 37596591BACKGROUND
  • Feraco A, Gorini S, Camajani E, Filardi T, Karav S, Cava E, Strollo R, Padua E, Caprio M, Armani A, Lombardo M. Gender differences in dietary patterns and physical activity: an insight with principal component analysis (PCA). J Transl Med. 2024 Dec 18;22(1):1112. doi: 10.1186/s12967-024-05965-3.

  • Feraco A, Armani A, Gorini S, Camajani E, Quattrini C, Filardi T, Karav S, Strollo R, Caprio M, Lombardo M. Gender Differences in Dietary Patterns and Eating Behaviours in Individuals with Obesity. Nutrients. 2024 Dec 6;16(23):4226. doi: 10.3390/nu16234226.

MeSH Terms

Conditions

Food PreferencesMotor Activity

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Massimiliano Caprio, MD, PhD

    IRCCS San Raffaele Roma

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mauro Lombardo, MD, Associate Professor in Dietetics and Clinical Nutrition

Study Record Dates

First Submitted

October 17, 2024

First Posted

October 23, 2024

Study Start

January 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

October 23, 2024

Record last verified: 2024-10

Locations