- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01982279
Longitudinal Measurement of Caloric Compensation and Eating in the Absence of Hunger in French Preschool Children
One Year Change in Caloric Compensation and Eating in the Absence of Hunger in French Preschool Children
Objectives: The aims were to measure one year change in caloric compensation (CC) and eating in the absence of hunger (EAH) in 3 to 6 year-old French children in their regular eating context and to link these change with individual characteristics (adiposity, age, gender) and maternal feeding practices.
Three series of measurements of caloric compensation (CC) and eating in the absence of hunger (EAH) were conducted: at baseline, and 3 (FU3M) and 15 (FU15M) months later. Each serie of measurement was composed of three consecutive weeks an identical lunch was served in four preschool canteens reaching 236 children. The first lunch was a control session. For the CC situation (week 2), thirty minutes before the lunch children were offered a preload (137 kcal). For the EAH situation (week 3), ten minutes after lunch children were exposed to palatable foods (430 kcal). Food intake was measured at the individual level. Maternal eating behaviour and feeding practices were measured by questionnaires. Child's height and weight were measured by a medical doctor.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Dijon, Frankrig, 21000
- Centre des Sciences du Goût et de l'Alimentation
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- To be registered to the school canteen, to provide parental approval at inclusion and at the FU15M
Exclusion Criteria:
- Chronic disease or food allergies
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tværsnit
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in caloric compensation in 15 months
Tidsramme: one week
|
To evaluate the change in caloric compensation across time, caloric compensation was measured at baseline, 3 and 15 months after baseline, in the same conditions.
At each time point to assess caloric compensation, children were offered a chocolate bun 30 minutes before the lunch.
The food intake at lunch was recorded.
We calculated if children compensated the chocolate bun, by comparing energy intake at this lunch with energy intake from a control lunch which took place one week before.
|
one week
|
|
Control measurement of energy intake at baseline
Tidsramme: One week
|
We conducted a control lunch and recorded food intake of each child.
This measurement was conducted a week before measuring caloric compensation.
|
One week
|
|
Change in eating in the absence of hunger in 15 months
Tidsramme: one week.
|
In order to evaluate the change in eating in the absence of hunger across time, a measurement was conducted at baseline, 3 months and 15 months after baseline.
To collect the measurement of eating in the absence of hunger, we offered palatable foods to children 10 minutes after their lunch.
We recorded the energy intake from these post-meal foods.
At each time point, this measurement was conducted one week after the measurement of caloric compensation.
|
one week.
|
|
Control measurement of energy intake three months after baseline
Tidsramme: One week
|
We conducted a control lunch and recorded food intake of each child.
This measurement was conducted a week before measuring caloric compensation.
|
One week
|
|
Control measurement of energy intake fifteen months after baseline
Tidsramme: One week
|
We conducted a control lunch and recorded food intake of each child.
This measurement was conducted a week before measuring caloric compensation.
|
One week
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maternal feeding practices and eating behavior
Tidsramme: one month after inclusion
|
Using a validated questionnaire, we collected information about maternal feeding practices (Comprehensive Feeding Practices Questionnaire, Musher-Eizenman & Holub, 2007) and eating behaviour (Dutch Eating Behaviour Questionnaire, Van Strien, 1986).
|
one month after inclusion
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Nicklaus Sophie, phD, Centre des Sciences du Goût et de l'Alimentation
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- HabEat WP31 Follow up
- INRA WP31 FU
- WP31.FU. INRA (Anden identifikator: INRA)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .