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

Study Overview
=================
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

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

Conditions
-----------------
Mediterranean Diet, Physical Activity, Sedentary Time, Sleep

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br> | Other: Exercise<br>* 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.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the Mediterranean diet | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical activity, Sedentary behavior, Screen time, Sleep duration, Movement guidelines