Prescription of Exercise in Children

NCT ID: NCT06765460

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-11-01

Brief Summary

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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

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* 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

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Children Exercise Physical Activity Screen Time

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
restrictive block randomization conducted using STATA version 16 software. Those within the intervention group received an individualized MPE, while participants in the control group received brief HA. To avoid classification bias in terms of PA level measurement, both the randomly selected intervention (HA and MPE) and the subsequent data collection (baseline, at 3 months and 12 months) were performed by the same blinded investigator, ensuring data consistency and validity. Participants did not know which intervention they were receiving as they did not know the actual recomendations in pediatric patients about exercise and screen time

Study Groups

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Medical prescription of exercise (MPE)

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.

Group Type EXPERIMENTAL

Medical prescription of exercise

Intervention Type BEHAVIORAL

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 Advice (HA)

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

Group Type ACTIVE_COMPARATOR

Health Advice

Intervention Type BEHAVIORAL

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

Interventions

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Medical prescription of exercise

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

Intervention Type BEHAVIORAL

Health Advice

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

chronic or complex pathology preventing moderate or intense physical activity or those who did not give consent
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Virgen de las Nieves

OTHER

Sponsor Role lead

Responsible Party

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Ángel Morillas Mingorance

Médico pediatra

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Avenida de las Fuerzas Armadas, 2, 18014, Granada

Granada, Granada, Spain

Site Status

Countries

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Spain

Other Identifiers

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Zaidin exercises

Identifier Type: -

Identifier Source: org_study_id

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