- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03018379
Body Composition, Dietary Behaviors, Energy Expenditure and Physical Activity Among Moroccan Schoolchildren and Adolescents
Assessment Study of Body Composition, Energy Expenditure and Physical Activity to Inform Design and Improve Interventions for the Prevention and Control of Obesity and Related Health Risks Among Schoolchildren and Adolescent Aged 8 to 14 Years in Morocco
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Apparently healthy
- Aged between 8 to 14 years old
Exclusion Criteria:
- Hypo or hypervolemic conditions including diet
- Diuretics and oedema
- Private schools
- Rural area
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
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Assessment of body composition
The collection of the samples and the analyses were undertaken according to the guidelines of the International Atomic Energy Agency.
In brief, after having emptied the bladder, each participant provided a predose saliva sample using a cotton ball.A 99.8 % deuterium dose of 0.5 g per kg body weight was given orally to the participant.
The postdose sample was collected from 3h to 4h after the administration of the dose.
The saliva samples were stored at 20°C until analysis by Fourier transform infrared spectroscopy (FTIR).
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Assessment of energy expenditure
Each participant provided a predose urine sample. A dose of doubly labelled water 2.625 ml per kg body weight was given orally to the participant. The post dose sample was collected at 3h to 4h , and on days 3, 7 and 14 after dosing. An aliquot of those samples were stored at 20°C in tightly sealed containers until analysis by isotope-ratio mass spectrometry (IRMS). |
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Assessment of physical activity
The participants were instructed to wear the accelerometer triaxial (GT3X+) attached to an elasticized belt around the waist, once they woke up until bed time at night for 7 consecutive days and to remove the accelerometer any time they were to perform activities that involve the use of water and when going to bed.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessment of body composition using deuterium dilution technique
Tidsramme: 1 year
|
Each participant provided a predose saliva sample.
The postdose sample was collected from 3h to 4h after the administration of the dose.
|
1 year
|
|
Assessment of energy expenditure using isotopes dilution techniques
Tidsramme: 1 year
|
Each participant provided a predose urine sample.
The postdose urine samples were collected after 3h to 4h and on days 3, 7 and 14.
|
1 year
|
|
Assessment of physical activity levels using accelerometry triaxial (GT3X+)
Tidsramme: 2 years 6 months
|
2 years 6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Assessment of dietary intake using 24h recall questionnaire
Tidsramme: 6 months
|
6 months
|
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Assessment of physical activity levels using physical activity questionnaire for children (PAQ-C)
Tidsramme: 2 years 6 months
|
2 years 6 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Asmaa EL HAMDOUCHI, Dr, Unité Mixte de Recherche en Nutrition, CNESTENIbn Tofail university
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- RAF642
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