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Completed

NCT Number: NCT07065097

Impact an Educational Multimodal Intervention to Improve Healthy Habits in Adolescents.

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.

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Key information

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nursing and Ocupational Therapy College. University of Extremadura, Cáceres, Caceres, Spain

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

. Inclusion Criteria:

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

Exclusion criteria

  • 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.

Treatment and study plan

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

Other

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

Primary outcomes

  1. Self steem

    Time frame: 4 months

    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.

  2. Body image

    Time frame: 4 months

    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).

  3. self concept

    Time frame: 4 months

    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. Nutrition

    Time frame: 4 months

    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)

Sponsors and collaborators

Lead sponsor

University of Extremadura

Other

Registry information

Official study title

Impact an Educational Multimodal Intervention to Improve Healthy Habits in Adolescents

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jul 15, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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