Life QualityNCT07080541
Protocol for a Natural-Based Intervention to Promote Quality of Life and Healthy Habits on Children and Adolescents.
A study testing Physical literacy and life satisfaction and Analogic information in people with Life Quality and Physical Activities, run by Universidad de Extremadura at 1 site in Spain.
Trial summary
In current society, physical activity practices show a decreasing trend, together with a low perception of life quality. In addition, urban overcrowding has led to disconnection from the natural environment, causing the benefits that this context offers to be lost, especially for children and adolescents. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Life Quality, Physical Activities, Life Style, Healthy
- What is being tested?
- Physical literacy and life satisfaction and Analogic information
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 728 participants
- Where
- 1 siteSpain
- Study dates
- 28 Apr 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Parental consent
- Participation on summer camps
Who cannot join
- Older than 18 years
- Not having parental consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Natural-Based Multicomponent Intervention to Promote Quality of Life and Healthy Habits on Children and Adolescents: Protocol for a Randomized Controlled Trial
In current society, physical activity practices show a decreasing trend, together with a low perception of life quality. In addition, urban overcrowding has led to disconnection from the natural environment, causing the benefits that this context offers to be lost, especially for children and adolescents. Physical literacy is an approach to physical activity that encompasses more than just individual physical skills. It emphasises the importance of performing physical activity on a regular basis as part of daily life, encompassing bodily expression and understanding, as well as self-confidence and motivation, making it a factor that contributes to quality of life. Although research shows a correlation between physical literacy and life satisfaction, there is no research on other variables, such as the impact of green spaces in this correlation. This study aimed to present the rationale and methods of a randomized controlled trial in green spaces for children and adolescents aged 8 to 18 to evaluate the efficacy of a nature-based intervention designed to promote healthy habits through physical literacy and quality of life through life satisfaction. The statistical techniques applied will include a comprehensive method encompassing sociodemographic information, physical activity levels, perceptions of physical literacy, and life satisfaction. The camp shifts were randomly distributed, with half in the control group and the other half in the experimental group . Two measures of physical literacy and life satisfaction were measured: one at the beginning of the camp and one on the day of completion. The intervention included 24 sessions of adventure activities carried out in a natural environment, and the values obtained for both variables were collected using two questionnaires validated for these age groups. This intervention is expected to improve levels of physical literacy and perceived life satisfaction by providing valuable
- Being tested
- Physical literacy and life satisfaction, Analogic information
- Keywords
- physical activity, physical literacy, quality of life, natural environment, nature
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical literacy and life satisfactionOther
Participants in the technology experimental group will engage in physical activity in nature while being exposed to information pills on physical literacy and the importance of physical activity in health to improve quality of life and life satisfaction via social media
Analogic informationOther
Participants in the analogic experimental group will engage in physical activity in nature while being exposed to information pills on physical literacy and the importance of physical activity in health to improve quality of life and life satisfaction via paper sheets.
| Study group | Role | What they receive |
|---|---|---|
| Physical literacy information | Experimental | Participants in the technology experimental group received physical literacy and life satisfaction information prior to the adventure activities via social media. Receives: Other: Physical literacy and life satisfaction |
| Analogic information | Experimental | Participants in the analogic experimental group received physical literacy and life satisfaction information prior to the adventure activities using paper sheets. Receives: Other: Analogic information |
| Participants physical activity intervention (no information) | No intervention | Participants in the analogic experimental group received physical literacy and life satisfaction information prior to the adventure activities using paper sheets. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical literacy
Physical literacy encomprises physical competence, knowledge and understanding and self-expression. This outcome will be assessed by "Students Perceived Physical Literacy Scale", validated by López-Gil et al. (2023) on adolescents. This scale is measured on a 1--5 Likert scale (from 1 "strongly disagree" to 5 "Strongly agree")
Measured: From day 1 of the camp to day 12 (last day of camp)
Life Satisfaction
Life satisfaction measure quality of life within last four weeks, according to self perception. This variable will be evaluated by "Students Life Satisfaction Scale", validated on adolescents.
Measured: From day 1 of camp to 12 days (last day of camp)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start28 Apr 2025
- Primary completionSep 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Life QualityStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 728 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noelia Mayordomo, Universidad de Extremadura
- Investigators
- Mayordomo-Pinilla, PhD Student, Principal investigator, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080541
- Sponsor's protocol ID
- 139//2024
- Status last verified
- Jul 2025
- First submitted
- 26 May 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural-Based Multicomponent Intervention to Promote Quality of Life and Healthy Habits on Children and Adolescents: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07080541
- Acronym / sponsor ID
- 139//2024
- Keywords
- physical activity, physical literacy, quality of life, natural environment, nature
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 728 participants (estimated)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 23 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.
In current society, physical activity practices show a decreasing trend, together with a low perception of life quality. In addition, urban overcrowding has led to disconnection from the natural environment, causing the benefits that this context offers to be lost, especially for children and adolescents. Physical literacy is an approach to physical activity that encompasses more than just individual physical skills. It emphasises the importance of performing physical activity on a regular basis as part of daily life, encompassing bodily expression and understanding, as well as self-confidence and motivation, making it a factor that contributes to quality of life. Although research shows a correlation between physical literacy and life satisfaction, there is no research on other variables, such as the impact of green spaces in this correlation. This study aimed to present the rationale and methods of a randomized controlled trial in green spaces for children and adolescents aged 8 to 18 to evaluate the efficacy of a nature-based intervention designed to promote healthy habits through physical literacy and quality of life through life satisfaction. The statistical techniques applied will include a comprehensive method encompassing sociodemographic information, physical activity levels, perceptions of physical literacy, and life satisfaction. The camp shifts were randomly distributed, with half in the control group and the other half in the experimental group . Two measures of physical literacy and life satisfaction were measured: one at the beginning of the camp and one on the day of completion. The intervention included 24 sessions of adventure activities carried out in a natural environment, and the values obtained for both variables were collected using two questionnaires validated for these age groups. This intervention is expected to improve levels of physical literacy and perceived life satisfaction by providing valuable
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical literacy information | Experimental | Other: Physical literacy and life satisfactionParticipants in the technology experimental group received physical literacy and life satisfaction information prior to the adventure activities via social media. |
| Analogic information | Experimental | Other: Analogic informationParticipants in the analogic experimental group received physical literacy and life satisfaction information prior to the adventure activities using paper sheets. |
| Participants physical activity intervention (no information) | No intervention | –Participants in the analogic experimental group received physical literacy and life satisfaction information prior to the adventure activities using paper sheets. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Parental consent
- Participation on summer camps
Key exclusion criteria (2 listed)
- Older than 18 years
- Not having parental consent.
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 |
|---|---|---|
| Physical literacy and life satisfactionParticipants in the technology experimental group will engage in physical activity in nature while being exposed to information pills on physical literacy and the importance of physical activity in health to improve quality of life and life satisfaction via social media | Other | Physical literacy information |
| Analogic informationParticipants in the analogic experimental group will engage in physical activity in nature while being exposed to information pills on physical literacy and the importance of physical activity in health to improve quality of life and life satisfaction via paper sheets. | Other | Analogic information |
Primary outcome
Physical literacy
Time frame: From day 1 of the camp to day 12 (last day of camp)
Physical literacy encomprises physical competence, knowledge and understanding and self-expression. This outcome will be assessed by "Students Perceived Physical Literacy Scale", validated by López-Gil et al. (2023) on adolescents. This scale is measured on a 1--5 Likert scale (from 1 "strongly disagree" to 5 "Strongly agree")
Life Satisfaction
Time frame: From day 1 of camp to 12 days (last day of camp)
Life satisfaction measure quality of life within last four weeks, according to self perception. This variable will be evaluated by "Students Life Satisfaction Scale", validated on adolescents.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- 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.
Mayordomo-Pinilla, PhD Student principal investigator
University of Extremadura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical literacy and life satisfaction and Analogic information in people with Life Quality and Physical Activities, run by Universidad de Extremadura at 1 site 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 2 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: under way, not looking for participants, as of the sponsor's last update on 23 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 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Physical literacy (time frame: From day 1 of the camp to day 12 (last day of camp)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2025.