Diet, HealthyNCT07065097
Impact an Educational Multimodal Intervention to Improve Healthy Habits in Adolescents.
A study testing A multimodal intervention in which they worked on self-esteem, self-concept and body image and nutrition. in people with Diet, Healthy and Adolescent Overweight, run by University of Extremadura at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Adolescent Overweight, Child Nutrition Sciences
- What is being tested?
- A multimodal intervention in which they worked on self-esteem, self-concept and body image and nutrition.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 2 sitesSpain
- Study dates
- 8 Jan 2018to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Nursing and Ocupational Therapy College. University of Extremadura
Cáceres, Caceres, 10003
Nursing and Ocupational Therapy College. University of Extremadura
Cáceres, CÁCERES, 10003
About this study
Official title: Impact an Educational Multimodal Intervention to Improve Healthy Habits in Adolescents
Background:
Adolescence is a critical period to promote healthy habits.
Read more
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.
- Conditions
- Diet, Healthy, Adolescent Overweight, Child Nutrition Sciences, Exercise, Self Concept, Body Dissatisfaction
- Being tested
- A multimodal intervention in which they worked on self-esteem, self-concept and body image and nutrition.
- Keywords
- Diet, Healthy, Adolescent, Physical Activity, Exercise, self concept, body image
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: A multimodal intervention in which they worked on self-esteem, self-concept and body image and nutrition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start8 Jan 2018
- Primary completion28 Feb 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled and intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fidel Lopez Espuela, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065097
- Sponsor's protocol ID
- UExtremadura2020
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37036415
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact an Educational Multimodal Intervention to Improve Healthy Habits in Adolescents
- ClinicalTrials.gov ID
- NCT07065097
- Acronym / sponsor ID
- UExtremadura2020
- Conditions
- Diet, Healthy, Adolescent Overweight, Child Nutrition Sciences, Exercise, Self Concept, Body Dissatisfaction
- Keywords
- Diet, Healthy, Adolescent, Physical Activity, Exercise, self concept, body image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Controlled and intervention
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| Intervention group | Experimental | Other: A multimodal intervention in which they worked on self-esteem, self-concept and body image and nutrition.This group underwent a multimodal intervention in which they worked on self-esteem, self-concept and body image. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A multimodal intervention in which they worked on self-esteem, self-concept and body image and nutrition.A multimodal intervention in which they worked on self-esteem, self-concept and body image and nutrition. | Other | Intervention group |
Primary outcome
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.
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).
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Background: PubMed 37036415Benitez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A multimodal intervention in which they worked on self-esteem, self-concept and body image and nutrition. in people with Diet, Healthy and Adolescent Overweight, run by University of Extremadura at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self steem (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07065097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.