SloFitCovid: Nutritional Status of Adult Slovenes After the Covid-19 Epidemic

Sponsor
Barbara Jakše s.p. (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05438966
Collaborator
(none)
900
1
2.1
421.4

Study Details

Study Description

Brief Summary

There is objective need to examine nutritional status (i.e., body mass index (BMI), body composition and dietary intake) of healthy adult Slovenes after SARS-CoV-2 (Covid-19) epidemic period.

In the Slovenian (pair of European Union) adult population (with only 2 million inhabitants), we do not yet have representative data on the body composition of adult Slovenes published in the scientific literature.

In the study after the Covid-19 pandemic period (4th wave) the investigators will use medically approved body analyzer (Tanita 780 S MA, Tokyo, Japan) and standardized food frequency questionnaire (FFQ). In addition, the investigators will measured body height of the participants with a portable altimeter (ADE MZ10042, Germany).

The research will include randomly recruited adults (participants) who will attend various free or/and paid publicly available seminars, congresses and fairs in Slovenia, directly unrelated topics to physical activity or healthy eating (i.e., healthy and active lifestyle) thus obtaining a more realistic current population status.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Detailed Description

In the study investigators will randomly but voluntarily enroll 700-1000 healthy adult participants within inclusion/exclusion criteria that are willing to participate in the study. Investigators anticipate that for this number of adults (aged 18-80 years) will require approx. 5000 invited candidates (10-15 events), of both sexes.

The methods to be used are body composition monitor and FFQ. In addition to the assessment of BMI and body composition status, we will compare the proportion of obese subjects according to BMI and body fat percentage threshold criteria (by World Health Organization). For the dietary intake analysis the investigators will use the national a dietary software program, OPEN Platform for Clinical Nutrition, which is a web-based application developed by the Jožef Stefan Institute in Slovenia.

The power of the sample was calculated on the basis of published body composition data on the adult population of the scientific monographs of the Slovenian National Institute of Public Health and data on the BMI of the scientific research on the dietary intake status of adults (SI.Menu).

The participants included in the study will signed consent form for inclusion in the study and will not be remunerated financially for participation in the study.

Study Design

Study Type:
Observational
Anticipated Enrollment :
900 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Body Composition and Dietary Intake Status of Adult Slovenes After the Covid-19 Epidemic
Actual Study Start Date :
Jun 28, 2022
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Body weight status [June-September 2022]

    Body weight measured with medically approved body composition monitor

  2. Height status [June-September 2022]

    Height status measured with medically approved weighing scale with height rod

  3. Body mass index (BMI) status [June-September 2022]

    Measured body weight and body height will be combined to report BMI in kg/m2

  4. Body fat percentege status [June-September 2022]

    Body fat percentage measured with medically approved body composition monitor

  5. Muscle mass percantage status [June-September 2022]

    Muscle mass percantage measured with medically approved body composition monitor

Secondary Outcome Measures

  1. Dietary intake status [June-September 2022]

    Dietary intake measured by standardized food frequency questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy adults

  • No BMI restriction

  • Randomly invited

Exclusion Criteria:
  • Without currently competitive or top level athletes

  • Without pregnant or lactating women and physically handicapped individuals

  • Without active common chronic diseases (i.e., cancer, CVD, autoimmune diseases ect.)

  • Without individuals with a pacemaker

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of sport Ljubljana Slovenia 1000

Sponsors and Collaborators

  • Barbara Jakše s.p.

Investigators

  • Principal Investigator: Boštjan Jakše, PhD, Independent Researcher
  • Study Chair: Stanislav Pinter, PhD, University of Ljubljana

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Boštjan Jakše, Boštjan Jakše, Principal Investigator, Barbara Jakše s.p.
ClinicalTrials.gov Identifier:
NCT05438966
Other Study ID Numbers:
  • KR6
First Posted:
Jun 30, 2022
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022