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De klinische studie NCT05521490 voor Lichamelijke activiteit, Cardiorespiratoire fitheid is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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Combating Physical Inactivity Pandemic in Kindergartens

Recruterend
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De klinische studie NCT05521490 is een interventioneel studie bij Lichamelijke activiteit, Cardiorespiratoire fitheid met de status recruterend. Het doel is om 3.300 deelnemers te includeren vanaf 1 augustus 2022. De studie wordt geleid door de Universiteit van Hongkong en de voltooiing is gepland op 1 december 2026. Laatste update op ClinicalTrials.gov: 30 augustus 2022.
Beknopte samenvatting
The aim of this study is to examine the effects of a kindergarten-based, parent-involved intervention during the upper kindergarten year (K3) on physical activity and physical fitness in preschool children.
Uitgebreide beschrijving
This study is a two-arm cluster randomized controlled trial. Kindergartens will be randomly allocated to two groups: the usual care group and the intervention group. The usual care group will continue with their usual curriculum, which includes 30 minutes of daily physical activity stipulated by the Hong Kong SAR Government's Education Bureau. The intervention group will receive an additional 2.5 hours of physical activity per week in addition to the stipulated 30 minutes of daily physical activity. Outcome measures will be examined at baseline, 10 months (post-intervention), and 16 months (follow-up).
Officiële titel

Combating Physical Inactivity Pandemic by Promoting Physical Fitness Education and Physical Activity-Embedded Curriculum in Kindergartens

Aandoeningen
Lichamelijke activiteitCardiorespiratoire fitheid
Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:
Andere studie-ID's
  • HK-KIDFIT
NCT-ID
NCT05521490
Startdatum (Werkelijk)
2022-08
Laatste update geplaatst
2022-08-30
Verwachte einddatum
2026-12
Inschrijving (Geschat)
3.300
Studietype
Interventioneel
FASE
N.v.t.
Status
Recruterend
Trefwoorden
Childhood Physical Inactivity
Childhood Obesity
Primaire doel
Preventie
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Enkelblind
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
OverigeUsual Care Control
Children allocated to the control group will continue with their usual curriculum, which includes the stipulated 30 minutes of daily physical activity.
Gebruikelijke zorgcontrole
30 minutes of physical activity on each school day.
ExperimenteelPhysical Activity Enhanced Curriculum
Children allocated to the intervention group will receive enhanced physical fitness and healthy lifestyle education and a physical activity enhanced curriculum during their school year.
Physical Activity Enhanced Curriculum
Additional 2.5 hours of physical activity per week in addition to the stipulated 30 minutes of daily physical activity.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Change in Physical Activity
Physical activity will be assessed using an actigraph device with a three-axis accelerometer.
Baseline and 10 months
Change in Cardiorespiratory Fitness
Cardiorespiratory fitness will be assessed using the 20-meter shuttle run test.
Baseline and 10 months
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Change in Physical Activity
Physical activity will be assessed using an actigraph device with a three-axis accelerometer.
Baseline and 16 months
Change in Cardiorespiratory Fitness
Cardiorespiratory fitness will be assessed using the 20-meter shuttle run test.
Baseline and 16 months
Change in Muscular Strength
Muscular strength will be assessed using a handgrip dynamometer.
Baseline, 10 months, and 16 months
Change in Flexibility
Flexibility will be assessed using the sit-and-reach test.
Baseline, 10 months, and 16 months
Change in Agility
Agility will be assessed using a 4 x 10-meter shuttle run test.
Baseline, 10 months, and 16 months
Change in Balance Ability
Balance ability will be assessed by the number of successful steps performed on a balance beam.
Baseline, 10 months, and 16 months
Change in Muscle Power
Muscle power will be assessed using a vertical jump and a stationary long jump test.
Baseline, 10 months, and 16 months
Change in Body Mass Index
Weight and height will be assessed using a calibrated electronic digital weighing scale and stadiometer respectively.
Baseline, 10 months, and 16 months
Change in Waist Circumference
Waist circumference will be assessed using an inelastic measuring tape to the nearest 0.1cm.
Baseline, 10 months, and 16 months
Change in Body Fat
Body fat will be assessed using a bioelectrical impedance-based multi-frequency segmental body composition analyzer (MC780, Tanita, Japan).
Baseline, 10 months, and 16 months
Change in Fat-Free Mass
Fat-free mass will be assessed using a bioelectrical impedance-based multi-frequency segmental body composition analyzer (MC780, Tanita, Japan).
Baseline, 10 months, and 16 months
Change in Sedentary Behavior and Screen Time
Sedentary behavior and screen time will be assessed using a 7-day activities logbook and accelerometer data.
Baseline, 10 months, and 16 months
Change in Treatment Self-Regulation Questionnaire Score
Treatment Self-Regulation Questionnaire (TSRQ) will be used to assess the children's autonomous motivation and beliefs on active healthy lifestyles. The items in TSRQ will be answered on a 3-point Likert scale with a higher score corresponding to greater autonomous motivation.
Baseline, 10 months, and 16 months
Change in Theory of Planned Behavior Scale Score
Theory of Planned Behavior Scale (TPBS) will be used to assess the children's social cognitive beliefs of health and physical activity behavior. The items in TPBS will be answered on a 3-point Likert scale with a higher score corresponding to a greater willingness to engage in the mentioned behaviors.
Baseline, 10 months, and 16 months
Change in Kiddy-KINDL
Kiddy-KINDL will be used to assess the health-related quality of life in children.
Baseline, 10 months, and 16 months
Change in Early Development Instrument
Early Development Instrument (EDI) will be used to assess the children's general well-being.
Baseline, 10 months, and 16 months
Geschiktheidscriteria

Leeftijd van deelnemers
Kind
Minimumleeftijd
5 Years
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja
  1. Children aged 5-6 years (limited number of children may be between 4-5 and 6-7 years)
  2. Able to communicate in Chinese
  3. Able to participate in physical activity in a standard kindergarten setting

  1. Inherent or serious disease limiting participation in physical activity (e.g., congenital heart disease, pediatric cancer, Down syndrome).
  2. Diagnosed mental illness impairing daily behavior and performance (e.g., anxiety disorder, depression, attention deficit hyperactivity disorder, psychotic disorders, autism spectrum disorder).
  3. Physical disability (e.g., physical handicap, assistive device to walk).
  4. Visual or hearing impairment.
  5. Cognitive deficit or intellectual disability that requires special care and educational needs (e.g., handicapped children with learning difficulties).
The University of Hong Kong logoUniversiteit van Hongkong349 actieve klinische studies om te verkennen
Centraal Contactpersoon
Contact: Parco M Siu, PhD, 2831, [email protected]
1 Studielocaties in 1 landen
LKS Faculty of Medicine, Hong Kong, Hong Kong
Parco M Siu, PhD, Contact
Recruterend