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

Sponsor
University of Castilla-La Mancha (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05620303
Collaborator
(none)
100
1
2
9.9
10.1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Cluster randomized controlled trialCluster randomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Other
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
Anticipated Study Start Date :
Dec 2, 2022
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

  1. Adherence to the Mediterranean diet [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.

  2. 24-h movement behaviors (accelerometers) sedentary time [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.

  3. 24-h movement behaviors (self-reported) [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.

  4. 24-h movement behaviors (accelerometers) physical activity [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.

  5. 24-h movement behaviors (accelerometers) sleep duration [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.

Secondary Outcome Measures

  1. Anthropometrics measurements [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.

  2. Active transportation [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.

  3. Resting blood pressure [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)].

  4. Sleep disorders [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.

  5. Health-related quality of life [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.

  6. Self-reported physical fitness [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)).

  7. Parents'/guardians' perception of their children's body mass index status [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?".

  8. Academic performance [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.

Other Outcome Measures

  1. 24-h movement behaviors (self-reported) parents/guardians [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).

  2. Adherence to the Mediterranean diet (parents/guardians) [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.

  3. Anthropometrics measurements (parents/guardians) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Colegio El Ope Murcia Spain 30600

Sponsors and Collaborators

  • University of Castilla-La Mancha

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Castilla-La Mancha
ClinicalTrials.gov Identifier:
NCT05620303
Other Study ID Numbers:
  • UCLMCFE00085
First Posted:
Nov 17, 2022
Last Update Posted:
Nov 30, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Castilla-La Mancha

Study Results

No Results Posted as of Nov 30, 2022