NCT06717620

Brief Summary

Introduction: Academic stress is defined as an activation reaction to stimuli and academic events that can cause alterations in diet and physical exercise. Students are the population most at risk of leading an unhealthy life as a result of stress. These bad habits and leading a sedentary lifestyle can cause an alteration in body composition and increase the risk of diseases. Methodology: This is an observational, comparative, prospective and longitudinal study based on the collection of data from the same group of students at two different stages of the year (before exam preparation, January 2024 and during exam preparation, May 2024). The tests carried out to assess eating habits, physical exercise and body composition were the Kidmed survey, the IPAQ test and measurement with a bioimpedance meter, respectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

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

November 11, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
Last Updated

December 5, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

November 13, 2024

Last Update Submit

November 30, 2024

Conditions

Keywords

Diet HealthyBody CompositionExerciseStress Psychological

Outcome Measures

Primary Outcomes (5)

  • KIDMED Questionnaire

    This questionnaire will be taken by the students before and after the exam period to see if the score obtained from it varies Quiz Score: KIDMED Index Value ≤ 3: Very low-quality diet 4 to 7: Need to improve the dietary pattern to adjust it to the Mediterranean model. * 8: Optimal Mediterranean diet The sums of the positive values were classified into three levels: * 8-12: Optimal Mediterranean diet (high adherence) * 4-7 improvement needed to adjust intake to Mediterranean patterns (medium adherence) * 0-3 very low diet quality (low adherence)

    6 months

  • INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE (IPAQ)

    This questionnaire will be taken by the students before and after the exam period to assess if there are changes in the score Value of the test: * Vigorous physical activity: 8 METs X minutes x days per week * Moderate physical activity: 4 METs x minutes x days per week * Walking: 3.3 x minutes x days per week EXAMPLE: 8 MET X 30 minutes x 5 days = 1200 MET (INTENSE PHYSICAL ACTIVITY) Next, add up the three values obtained: TOTAL: Vigorous physical activity + moderate physical activity + walking

    6 months

  • Fat mass

    Fat mass will be measured with a bioimpedance meter before and after the examination period to assess whether there are variations in the results obtained

    6 months

  • Muscle mass

    Muscle mass will be measured with a bioimpedance meter before and after the examination period to assess whether there are variations in the results obtained

    6 months

  • Visceral tissue

    Visceral tissue will be measured with a bioimpedance meter before and after the examination period to assess whether there are variations in the results obtained

    6 months

Secondary Outcomes (6)

  • Age

    6 months

  • Smoker

    6 months

  • caffeine or cola drinks

    6 months

  • Height

    6 months

  • Weight

    6 months

  • +1 more secondary outcomes

Study Arms (1)

UCM students

Measurements before and after the exam period

Behavioral: Body composition before and after exams

Interventions

Measurement of body composition, eating habits, physical exercise in the same group of students before and after the exams

UCM students

Eligibility Criteria

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

students of the Faculty of Nursing of the Complutense University of Madrid

You may qualify if:

  • Students over 18 years of age
  • Students enrolled in the second year of the Bachelor's Degree in Nursing
  • Students belonging to the Complutense University of Madrid

You may not qualify if:

  • Some physical inability to perform the impedance
  • Failure to take exams
  • Taking pharmacological treatments such as thyroid hormones, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Complutense de Madrid

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Body Weight ChangesMotor ActivityStress, Psychological

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBehavioral Symptoms

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor in health care. Principal Investigator. Clinical Professor

Study Record Dates

First Submitted

November 13, 2024

First Posted

December 5, 2024

Study Start

November 11, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

December 5, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Publication of the study

Shared Documents
STUDY PROTOCOL
Time Frame
Finals 2025

Locations