24-h Movement Behaviors and Adherence to the Mediterranean Diet in Children

March 24, 2023 updated by: University of Castilla-La Mancha

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Exercise group
Other: Exercise
Parents/guardians will receive three different contents weekly (i.e., infographics, video recipes, information pills, or videos) each week related to 24-h movement behaviors (i.e., PA, sedentary behavior, sleep duration) or Mediterranean Diet for 36 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to the Mediterranean diet
Time Frame: From baseline to 36 weeks later
To assess the adherence to the Mediterranean Diet, the Mediterranean Diet Quality Index for Children and Teenagers (KIDMED) index will be used.
From baseline to 36 weeks later
24-h movement behaviors (accelerometers) sedentary time
Time Frame: From baseline to 36 weeks later
A tri-axial accelerometer (Actigraph GT3x, Pensacola, FL, USA) will be used to assess sedentary time over seven consecutive days.
From baseline to 36 weeks later
24-h movement behaviors (self-reported)
Time Frame: From baseline to 36 weeks later
Self-report of physical activity levels and sedentary behaviors in youth will assessed by the Youth Activity Profile - Spain. In this questionnaire, a rating scale is used with a score from 1 to 5 in which, in the first two sections, "1" indicates low intensity and frequency of physical activity and "5" indicates high intensity and frequency of physical activity; while, in the third section, "1" indicates a low amount of sedentary behaviors and "5" an excess of them.
From baseline to 36 weeks later
24-h movement behaviors (accelerometers) physical activity
Time Frame: From baseline to 36 weeks later
A tri-axial accelerometer (Actigraph GT3x, Pensacola, FL, USA) will be used to assess physical activity over seven consecutive days.
From baseline to 36 weeks later
24-h movement behaviors (accelerometers) sleep duration
Time Frame: From baseline to 36 weeks later.
A tri-axial accelerometer (Actigraph GT3x, Pensacola, FL, USA) will be used to assess sleep duration over seven consecutive days.
From baseline to 36 weeks later.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometrics measurements
Time Frame: From baseline to 36 weeks later
The body weight of the schoolchildren will be measured using an electronic scale (with an accuracy of 0.1 kg) (Tanita BC-545, Tokyo, Japan), while height will be determined by a portable height rod with an accuracy of 0.1 cm (Leicester Tanita HR 001, Tokyo, Japan). Body mass index (BMI) will be calculated by dividing body weight (in kg) by the height (in squared meters). Furthermore, BMI z-score will be computed by the WHO age-specific and sex-specific thresholds.
From baseline to 36 weeks later
Active transportation
Time Frame: From baseline to 36 weeks later
Active transportation to and from school is evaluated by a self-reported questionnaire (Mode and Frequency of Commuting To and From School Questionnaire). Participants were categorized as "active" if reported: ≥2 active travel days out of 5 school days (questions #1 and #2) and ≥ 4 active travel trips out of 10 school trips per week (question #3). The usual mode of commuting to/from school was categorized as active when participants reported ≥ 1 active travel per day out of 2 daily school trips (question #4). Those who were not categorized as "active commuting" were categorized as "passive commuting" users.
From baseline to 36 weeks later
Resting blood pressure
Time Frame: From baseline to 36 weeks later
Resting blood pressure will be measured using an automated blood pressure monitor with a fittingly sized cuff (Omrom® EVOLV HEM-7600T-E, Health-care Co, Kyoto, Japan). First, schoolchildren will be seated in a quiet room for 10 min with their feet on the ground and their back supported. Two readings will be taken, with the second blood pressure reading taken five min after the first. The average of the two measurements for systolic blood pressure and diastolic blood pressure will be retained. Subsequently, mean arterial pressure will be computed by the following formula: diastolic blood pressure + [0.333 × (systolic blood pressure - diastolic blood pressure)].
From baseline to 36 weeks later
Sleep disorders
Time Frame: From baseline to 36 weeks later
Sleep disorders will be evaluated by the BEARS (B = Bedtime Issues, E = Excessive Daytime Sleepiness, A = Night Awakenings, R = Regularity and Duration of Sleep, S = Snoring) scale. Any questions that are answered positively indicate a sleep problem.
From baseline to 36 weeks later
Health-related quality of life
Time Frame: From baseline to 36 weeks later
Health-related quality of life will be measured by Child Health Utility 9D (CHU9D). The CHU9D consists of 9 dimensions: worried, sad, pain, tired, annoyed, schoolwork/homework, sleep, daily routine, ability to join in activities with five different levels representing increasing levels of severity within each dimension. Furthermore, CHU9D scores will be used in cost-utility analyses.
From baseline to 36 weeks later
Self-reported physical fitness
Time Frame: From baseline to 36 weeks later
Self-reported physical fitness will be assessed by the International Fitness Scale (IFIS), which is composed of a 5-point Likert-scale items asking about the children' perceived global physical fitness, cardiorespiratory fitness, muscular fitness, speed-agility, and flexibility in comparison with their counterparts' physical fitness (very poor (1), poor (2), average (3), good (4), and very good (5)).
From baseline to 36 weeks later
Parents'/guardians' perception of their children's body mass index status
Time Frame: From baseline to 36 weeks later
This outcome will be evaluated with the following question: "In relation to his/her height, which of the following options best describes your child's weight: 1) substantially above normal, 2) slightly above normal, 3) normal, 4) below normal?".
From baseline to 36 weeks later
Academic performance
Time Frame: From baseline to 36 weeks later.
Academic records will be provided at the end of the academic year by the school. Firstly, academic performance will be evaluated according to the grade obtained in Language, Mathematics, Language and Mathematics (combined), English, as well as the grade point average of these three subjects. Secondly, academic performance will be assessed by computing the grade point average of all the subjects taken by the children.
From baseline to 36 weeks later.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-h movement behaviors (self-reported) parents/guardians
Time Frame: From baseline to 36 weeks later.
The level of physical activity and sitting time will be assessed by the International Physical Activity Questionnaire-short form (IPAQ-SF).
From baseline to 36 weeks later.
Adherence to the Mediterranean diet (parents/guardians)
Time Frame: From baseline to 36 weeks later.
Parents/guardians will be also administered a 17-item Mediterranean dietary questionnaire, a modified version of the previously validated questionnaire used in the PREDIMED trial designed to assess adherence to Mediterranean Diet. Meeting with each of the 17 items relating to characteristic food habits will be scored with zero or one point. Therefore, the total score will range from 0 to 17 points, with 0 points denoting no adherence to the MD and 17 meaning maximum adherence to the Mediterranean Diet.
From baseline to 36 weeks later.
Anthropometrics measurements (parents/guardians)
Time Frame: From baseline to 36 weeks later.
The body weight and body height of the parents/guardians will be self-reported. Body mass index (BMI) will be computed by dividing body weight (in kg) by the height (in squared meters).
From baseline to 36 weeks later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Castilla-La Mancha

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2022

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

November 9, 2022

First Submitted That Met QC Criteria

November 9, 2022

First Posted (Actual)

November 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UCLMCFE00085

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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