Clinical trial NCT05620303: 24-h Movement Behaviors and Adherence to the Mediterranean Diet in Children
Official title: A Healthy Lifestyle-based Randomized Controlled Trial on 24-h Movement Behaviors and Adherence to the Mediterranean Diet in Schoolchildren - The Archena Infancia Saludable Project: A Protocol Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mediterranean Diet
Physical Activity
Sedentary Time
Sleep
Keywords: Physical activity
Sedentary behavior
Screen time
Sleep duration
Movement guidelines
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 154
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the effects of the Archena Infancia Saludable project on adherence to MD and 24-h movement behaviors in schoolchildren


Eligibility criteria: Inclusion Criteria:

Schoolchildren aged 6-13 years will be eligible

Exclusion Criteria:

* Participants with any pathology that contraindicate exercise or that request special attention.
* Participants under pharmacological treatment that prevent them from receiving the contents of the activities of the program.
* Participants or parents/legal guardians presenting Spanish learning difficulties.
* Participants do not authorized by the parents/guardians to be included in the research project.
* Participants do not agree to take part in the research project.

Primary outcomes:
measure: Adherence to the Mediterranean diet
timeFrame: From baseline to 36 weeks later
measure: 24-h movement behaviors (accelerometers) sedentary time
timeFrame: From baseline to 36 weeks later
measure: 24-h movement behaviors (self-reported)
timeFrame: From baseline to 36 weeks later
measure: 24-h movement behaviors (accelerometers) physical activity
timeFrame: From baseline to 36 weeks later
measure: 24-h movement behaviors (accelerometers) sleep duration
timeFrame: From baseline to 36 weeks later.
Secondary outcomes:
measure: Anthropometrics measurements
timeFrame: From baseline to 36 weeks later
measure: Active transportation
timeFrame: From baseline to 36 weeks later
measure: Resting blood pressure
timeFrame: From baseline to 36 weeks later
measure: Sleep disorders
timeFrame: From baseline to 36 weeks later
measure: Health-related quality of life
timeFrame: From baseline to 36 weeks later
measure: Self-reported physical fitness
timeFrame: From baseline to 36 weeks later
measure: Parents'/guardians' perception of their children's body mass index status
timeFrame: From baseline to 36 weeks later
measure: Academic performance
timeFrame: From baseline to 36 weeks later.
Other outcomes:
measure: 24-h movement behaviors (self-reported) parents/guardians
timeFrame: From baseline to 36 weeks later.
measure: Adherence to the Mediterranean diet (parents/guardians)
timeFrame: From baseline to 36 weeks later.
measure: Anthropometrics measurements (parents/guardians)
timeFrame: From baseline to 36 weeks later.
Locations:
city: Murcia
country: Spain
facility: Colegio El Ope
Study officials:
References: