ChildrenNCT06765460
Prescription of Exercise in Children
A study testing Medical prescription of exercise and Health Advice in people with Children and Exercise, run by University Hospital Virgen de las Nieves at 1 site in Spain.
Trial summary
Most pediatric populations do not meet the physical activity (PA) recommendations set by international organizations. The effectiveness of casual PA advice provided during medical consultations has not been adequately assessed for its role in fostering this healthy habit. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Exercise, Physical Activity
- What is being tested?
- Medical prescription of exercise and Health Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2023to 1 Nov 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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- We included pediatric patients between 6 and 14 years of age who were part of two pediatric PC groups of an urban health centre in Granada (Spain) who attended a face-to-face consultation of any type.
Who cannot join
- chronic or complex pathology preventing moderate or intense physical activity or those who did not give consent
Trial locations and contacts
1 site in 1 country.
Spain1 site
Avenida de las Fuerzas Armadas, 2, 18014, Granada
Granada, Granada, 18014
About this study
Official title: Effectiveness of Medical Prescription of Exercise in Children to Increase Physical Activity Levels.
Most pediatric populations do not meet the physical activity (PA) recommendations set by international organizations. The effectiveness of casual PA advice provided during medical consultations has not been adequately assessed for its role in fostering this healthy habit. This study aims to evaluate the effectiveness of medical prescriptions for PA in increasing PA levels in children compared to standard health advice (HA), as well as measuring the effectiveness of these recommendations in reducing daily screen time (ST) in the pediatric population. A randomized controlled clinical trial with parallel groups was conducted, including 130 participants aged 6 to 14 years. Data on PA levels (duration and intensity), ST, and anthropometric measures were collected via questionnaire. Participants were divided into two groups: HA (3 minutes) and medical prescription of exercise [MPE] (10 minutes). PA levels were assessed at 3 and 12 months, with results recorded using the same questionnaire. A multivariate data analysis was performed. Further research is needed to develop effective and sustainable public health interventions to prevent long-term sedentary behavior in children.
Read the detailed description
- Both HA and MPE interventions could effectively increase children's PA duration and intensity, resulting in a higher PA classification range.
- An inverse relationship may be identified between ST and PA, suggesting that reducing ST could encourage healthier habits in children.
- Pediatricians play a pivotal role in promoting lifestyle changes through brief yet targeted interventions, significantly influencing children's PA levels and reducing ST. These findings highlight the need for further research to optimize public health initiatives within pediatric care.
- Conditions
- Children, Exercise, Physical Activity, Screen Time
- Being tested
- Medical prescription of exercise, Health Advice
- Keywords
- children, exercise, physical activity, Screen time
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical prescription of exerciseBehavioural
MPE consists of dedicating a specific time to establish a specific and individualized exercise plan for the patient, with the premises of fully assessing their physical fitness, motivation, adaptability to change and the possibility of exercising within their social environment, as well as the achievement of specific objectives within an agreed follow-up period
Health AdviceBehavioural
HA consists of providing the patient with information and motivation in line with general international recommendations to try to increase PA levels in their daily life. This advice can be given in a short period of time (up to three minutes) during any medical consultation
| Study group | Role | What they receive |
|---|---|---|
| Medical prescription of exercise (MPE) | Experimental | MPE consists of dedicating a specific time to establish a specific and individualized exercise plan for the patient, with the premises of fully assessing their physical fitness, motivation, adaptability to change and the possibility of exercising within their social environment, as well as the achievement of specific objectives within an agreed follow-up period. Receives: Behavioral: Medical prescription of exercise |
| Health Advice (HA) | Active comparator | providing the patient with information and motivation in line with general international recommendations to try to increase PA levels in their daily life. This advice can be given in a short period of time (up to three minutes) during any medical consultation Receives: Behavioral: Health Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efectiveness of MPE and HA
test whether brief HA and/or individualized MPE in PC increases physical activity levels in childhood.
Measured: from enrollment to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Feb 2023
- Primary completion1 Mar 2024
- Study completion1 Nov 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 ChildrenStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled clinical trial with parallel groups was conducted, including 130 participants aged 6 to 14 years. Data on PA levels (duration and intensity), ST, and anthropometric measures were collected via questionnaire. Participants were divided into two groups: HA (3 minutes) and medical prescription of exercise \[MPE\] (10 minutes). PA levels were assessed at 3 and 12 months, with results recorded using the same questionnaire. A multivariate data analysis was performed
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Virgen de las Nieves
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ángel Morillas Mingorance, University Hospital Virgen de las Nieves
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765460
- Sponsor's protocol ID
- Zaidin exercises
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Permission to reproduce material from other sources: Specific permissions and related documentation are available upon request
Publications
Morillas-Mingorance A, Garach Gomez A, Gutierrez Garcia I, Monereo Moreno I, Sanchez Ruiz-Cabello FJ, Maldonado J. Effectiveness of a medical exercise prescription to promote physical activity in children: a pragmatic randomized trial in primary care. Front Pediatr. 2026 Feb 10;14:1732438. doi: 10.3389/fped.2026.1732438. eCollection 2026.
PubMed 41743224
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Medical Prescription of Exercise in Children to Increase Physical Activity Levels.
- ClinicalTrials.gov ID
- NCT06765460
- Acronym / sponsor ID
- Zaidin exercises
- Conditions
- Children, Exercise, Physical Activity, Screen Time
- Keywords
- children, exercise, physical activity, Screen time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital Virgen de las NievesUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 9 Jan 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.
Most pediatric populations do not meet the physical activity (PA) recommendations set by international organizations. The effectiveness of casual PA advice provided during medical consultations has not been adequately assessed for its role in fostering this healthy habit. This study aims to evaluate the effectiveness of medical prescriptions for PA in increasing PA levels in children compared to standard health advice (HA), as well as measuring the effectiveness of these recommendations in reducing daily screen time (ST) in the pediatric population. A randomized controlled clinical trial with parallel groups was conducted, including 130 participants aged 6 to 14 years. Data on PA levels (duration and intensity), ST, and anthropometric measures were collected via questionnaire. Participants were divided into two groups: HA (3 minutes) and medical prescription of exercise [MPE] (10 minutes). PA levels were assessed at 3 and 12 months, with results recorded using the same questionnaire. A multivariate data analysis was performed. Further research is needed to develop effective and sustainable public health interventions to prevent long-term sedentary behavior in children.
Detailed description
- Both HA and MPE interventions could effectively increase children's PA duration and intensity, resulting in a higher PA classification range.
- An inverse relationship may be identified between ST and PA, suggesting that reducing ST could encourage healthier habits in children.
- Pediatricians play a pivotal role in promoting lifestyle changes through brief yet targeted interventions, significantly influencing children's PA levels and reducing ST. These findings highlight the need for further research to optimize public health initiatives within pediatric care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled clinical trial with parallel groups was conducted, including 130 participants aged 6 to 14 years. Data on PA levels (duration and intensity), ST, and anthropometric measures were collected via questionnaire. Participants were divided into two groups: HA (3 minutes) and medical prescription of exercise [MPE] (10 minutes). PA levels were assessed at 3 and 12 months, with results recorded using the same questionnaire. A multivariate data analysis was performed
| Arm | Type | Receives |
|---|---|---|
| Medical prescription of exercise (MPE) | Experimental | Behavioral: Medical prescription of exerciseMPE consists of dedicating a specific time to establish a specific and individualized exercise plan for the patient, with the premises of fully assessing their physical fitness, motivation, adaptability to change and the possibility of exercising within their social environment, as well as the achievement of specific objectives within an agreed follow-up period. |
| Health Advice (HA) | Active comparator | Behavioral: Health Adviceproviding the patient with information and motivation in line with general international recommendations to try to increase PA levels in their daily life. This advice can be given in a short period of time (up to three minutes) during any medical consultation |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- We included pediatric patients between 6 and 14 years of age who were part of two pediatric PC groups of an urban health centre in Granada (Spain) who attended a face-to-face consultation of any type.
Key exclusion criteria (1 listed)
- chronic or complex pathology preventing moderate or intense physical activity or those who did not give 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 |
|---|---|---|
| Medical prescription of exerciseMPE consists of dedicating a specific time to establish a specific and individualized exercise plan for the patient, with the premises of fully assessing their physical fitness, motivation, adaptability to change and the possibility of exercising within their social environment, as well as the achievement of specific objectives within an agreed follow-up period | Behavioural | Medical prescription of exercise (MPE) |
| Health AdviceHA consists of providing the patient with information and motivation in line with general international recommendations to try to increase PA levels in their daily life. This advice can be given in a short period of time (up to three minutes) during any medical consultation | Behavioural | Health Advice (HA) |
Primary outcome
Efectiveness of MPE and HA
Time frame: from enrollment to 12 months
test whether brief HA and/or individualized MPE in PC increases physical activity levels in childhood.
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 9 Jan 2025.
- Derived from this study: PubMed 41743224Morillas-Mingorance A, Garach Gomez A, Gutierrez Garcia I, Monereo Moreno I, Sanchez Ruiz-Cabello FJ, Maldonado J. Effectiveness of a medical exercise prescription to promote physical activity in children: a pragmatic randomized trial in primary care. Front Pediatr. 2026 Feb 10;14:1732438. doi: 10.3389/fped.2026.1732438. eCollection 2026.
- Individual participant dataSharing planned: Yes. Permission to reproduce material from other sources: Specific permissions and related documentation are available upon request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical prescription of exercise and Health Advice in people with Children and Exercise, run by University Hospital Virgen de las Nieves 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 1 inclusion and 1 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 9 Jan 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?
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?
Efectiveness of MPE and HA (time frame: from enrollment to 12 months). 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 NCT06765460, 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 9 Jan 2025.