Prescription of Exercise in Children

NCT06765460 | Completed DMC

• 1 other identifier: Zaidin exercises
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Children; Exercise; Physical Activity; Screen Time

Keywords

children; exercise; physical activity; Screen time

Outcome Measures

Primary Outcomes (1)

• Efectiveness of MPE and HA

  test whether brief HA and/or individualized MPE in PC increases physical activity levels in childhood.

  from enrollment to 12 months

Study Arms (2)

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.

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

Behavioral: Health Advice

Interventions

Medical prescription of exercise 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

Medical prescription of exercise (MPE)

Health Advice 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

Health Advice (HA)

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• chronic or complex pathology preventing moderate or intense physical activity or those who did not give consent

Sponsors & Collaborators

• University Hospital Virgen de las Nieves: lead

Study Sites (1)

Avenida de las Fuerzas Armadas, 2, 18014, Granada

Granada, Granada, 18014, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Médico pediatra

Model Details: 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

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 9, 2025
• Study Start: February 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 9, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ES (1)