NCT07065097

Brief Summary

Background: Adolescence is a critical period to promote healthy habits. Objective: To know the impact that a multimodal educational intervention has on the knowledge and modification of healthy habits (HS) (Mediterranean diet (DM) and physical activity) in adolescents. Methodology: randomized controlled clinical trial, with multimodal educational intervention, in the Diocesan College of Cáceres. The participants will be assign to the control (GC) or experimental (GE) group by randomization, the latter received a multimodal educational intervention (theoretical and practical workshops on HS). Data will be collect: sociodemographic, academic notes, anthropometric data, KIDMED questionnaire and physical activity questionnaire (PAQ-A); Pre and post intervention. And knowledge about HS will be evaluate. The parents of the intervention group will receive workshops on healthy habits, benefits of diet and physical exercise, as well as the adolescents of the intervention group. All parents will grant consent to participate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
385

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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 8, 2018

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
Last Updated

July 15, 2025

Status Verified

August 1, 2024

Enrollment Period

6.1 years

First QC Date

August 29, 2024

Last Update Submit

July 14, 2025

Conditions

Keywords

Diet, HealthyAdolescentPhysical ActivityExerciseself conceptbody image

Outcome Measures

Primary Outcomes (4)

  • Self steem

    Self-esteem was assessed with the Rosenberg Scale. consists of 10 items and is a self-report instrument for evaluating an individual's overall self-esteem. The RSES is scored using four response options, ranging from strongly agree to strongly disagree. It is a two-dimensional scale: positive self-esteem (self-confidence or personal satisfaction) and negative self-esteem (self-contempt or personal devaluation). Five items are scored positively, and five items are scored negatively. The total score ranges from 10 to 40 points, with 10 points being the lowest self-esteem score and 40 points being the highest. With respect to the total score, a score of 30 to 40 points indicates high self-esteem; a score of 26 to 29 points indicates intermediate self-esteem; and a score less than or equal to 25 points indicate low self-esteem.

    4 months

  • Body image

    Dissatisfaction with body image was assessed with the Body shape questionnaire. This instrument evaluates dissatisfaction with body image due to body weight and shape; participants respond to items referring to how they have felt about their body shape in the last weeks. The questionnaire contains 34 self-report items; items are scored using a six-point Likert scale ranging from 1 (never) to 6 (always), with a total possible score ranging from 34 to 204 points. The higher the score is, the greater an individual's dissatisfaction with their body. Based on their BSQ results, the participants were divided into four groups according to dissatisfaction with physical appearance using the validated model: scores ≤80 (no dissatisfaction with BI); 81 ≤ scores ≤ 110 (slight dissatisfaction with BI); 111≤ scores ≤ 140 (moderate dissatisfaction with BI); and scores ≥ 141 (severe dissatisfaction with BI).

    4 months

  • self concept

    self-concept was assessed with the physical self-concept questionnaire. The Physical Activity Questionnaire for Adolescents (PAQ-A) assesses the physical exercise of the adolescent in the last 7 days. It consists of 9 questions that measure aspects of the physical exercise performed by the adolescent. It also provides information on whether the person has been ill. It is evaluated by means of a scale of 1 to 5 points that establishes a graduation of the level of physical activity carried out. It allows us to know at what time of the day and of the week the adolescent is most active.

    4 months

  • Nutrition

    the quality of the diet was assessed with the kidmed questionnaire. Kidmed questionnaire assesses adherence to the Mediterranean diet as a prototype of a healthy diet. The index consists of 16 questions, of which 12 are positive and 4 are negative; individuals who answer "yes" to positive questions receive +1 point, while those who answer "yes" to negative questions receive -1 point. Points are summed at the end of the evaluation, and a score ranging from 0 to 12 is obtained. The sum of these value scores is classified into 3 levels: ≥8 points indicates the optimal Mediterranean diet (good), scores between 4 and 7 points indicate that compatibility with the Mediterranean diet should be improved (moderate), and scores ≤3 points indicate very poor diet quality (low)

    4 months

Study Arms (2)

Control

NO INTERVENTION

No intervention

Intervention group

EXPERIMENTAL

This group underwent a multimodal intervention in which they worked on self-esteem, self-concept and body image.

Other: A multimodal intervention in which they worked on self-esteem, self-concept and body image and nutrition.

Interventions

A multimodal intervention in which they worked on self-esteem, self-concept and body image and nutrition.

Intervention group

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • aged between 11 and 16 years who were in their 1st and 2nd years of compulsory secondary education (ESO).

You may not qualify if:

  • adolescents with serious illnesses such as cancer or with serious mental health problems (depression requiring treatment) and
  • Adolescents who, despite having parental consent, did not wish to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nursing and Ocupational Therapy College. University of Extremadura

Cáceres, Caceres, 10003, Spain

Location

Nursing and Ocupational Therapy College. University of Extremadura

Cáceres, CÁCERES, 10003, Spain

Location

Related Publications (1)

  • Benitez-Sillero JD, Portela-Pino I, Morente A, Raya-Gonzalez J. Longitudinal Relationships Between Physical Fitness With Physical Self-Concept and Self-Esteem in Adolescents. Res Q Exerc Sport. 2024 Mar;95(1):183-189. doi: 10.1080/02701367.2023.2173134. Epub 2023 Apr 10.

    PMID: 37036415BACKGROUND

MeSH Terms

Conditions

Pediatric ObesityMotor Activity

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Controlled and intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Psicologist, Nurse Registered

Study Record Dates

First Submitted

August 29, 2024

First Posted

July 15, 2025

Study Start

January 8, 2018

Primary Completion

February 28, 2024

Study Completion

December 20, 2024

Last Updated

July 15, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations