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Snacks, smil og smakspreferanser

4. juni 2026 oppdatert av: Temple University

Nedgir søtpreferanse og tilsatt sukkerinntak under snacks

Forskningsstudien er designet for å finne ut om barns aksept av snacks med lavt sukkerinnhold, mest foretrukne nivå av søt og salt smak og kosttilskudd av tilsatt sukker endres etter gjentatt eksponering for snacks lavere i søthet sammenlignet med kontrollgruppen.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Dette er en longitudinell, randomisert, innenfor- og mellom-fagsstudie av barn og deres mødre for å avgjøre om barns gjentatte eksponering for snacks med lav søtthet og mødres pedagogiske leksjoner om tannhelse og ernæring (intervensjonsgruppe) påvirker barns aksept for lavt sukkerinnhold. snacks, mest foretrukket nivå av søt og salt smak, og diettinntak av tilsatt sukker sammenlignet med kontrollgruppen.

Studietype

Intervensjonell

Registrering (Faktiske)

172

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Monell Chemical Senses Center
      • Philadelphia, Pennsylvania, Forente stater, 19140
        • Temple University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

3 år til 6 år (Barn)

Tar imot friske frivillige

Ja

Beskrivelse

Inklusjonskriterier:

  • Engelsktalende mor 18 år eller eldre
  • Mor har hovedansvaret for det kvalifiserte barnets omsorg
  • Mor har hovedansvaret for å mate det berettigede barnet
  • Mor har ansvar for innkjøp av mat til familien
  • Mor må være villig til å avstå fra å spise mat og drikke med høyt tilsatt sukker i det kvalifiserte barnets tilstedeværelse så lenge studien varer

Ekskluderingskriterier:

  • Barnet er i heldags barnehage eller skole
  • Barnet er for tiden på en spesiell diett (f.eks. vektkontrollprogrammer)
  • Barnet har alvorlige matallergier (f. gluten, peanøtter)
  • Barn har medisinske tilstander som er kjent for å påvirke vekst eller spising (f. diabetes, cystisk fibrose)
  • Mor er en nåværende røyker

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Lav søt
Barn i intervensjonsgruppen vil få daglige snacks med lavt tilsatt sukker og søthet, og mødrene deres vil motta undervisningstimer om tannpleie, lesing av matetiketter og ernæring som støtter målene om å redusere "søt" eksponering og tilsatt sukkerinntak.
Barn i den eksperimentelle gruppen får gjentatt eksponering for mindre søte snacks og mødre får opplæring i tannpleie, lesing av matetiketter, porsjonsstørrelse og ernæring.
Sham-komparator: Vanlig søt
Barn i den vanlige søtekontrollgruppen vil få vanlige snacks matet til barn i denne alderen, og mødre vil få undervisning om porsjonsstørrelse, fysisk aktivitet, søvn, skjermtid og, på slutten av forsøket, tannpleie.
Barn i sham-komparator får typiske snacks og mødre får opplæring i porsjonsstørrelse, fysisk aktivitet, søvn og skjermtid.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Children's Dietary Intake of Energy From Added Sugar (Tsp/d)
Tidsramme: From T1 (baseline Temple visit at start of intervention) to T2 (Month 2, mid-trial), T3 (Month 4, end of intervention) and T4 (Month 5, which is 1 month post-intervention follow-up)
Children's dietary intake of added sugar (tsp/d) was determined from Automated Self-Administered Recall System (ASA24) at baseline, mid-trial, and end of trial.
From T1 (baseline Temple visit at start of intervention) to T2 (Month 2, mid-trial), T3 (Month 4, end of intervention) and T4 (Month 5, which is 1 month post-intervention follow-up)
Caregiver's Dietary Intake of Energy From Added Sugar (Tsp/d)
Tidsramme: At T1 (baseline Temple visit at start of intervention) to T2 (Month 2, mid-trial), T3 (Month 4, end of intervention) and T4 (Month 5, which is 1 month post-intervention follow-up)
Caregivers' dietary intake of added sugar (tsp/d) was determined from Automated Self-Administered Recall System (ASA24) at baseline, mid-trial, and end of trial.
At T1 (baseline Temple visit at start of intervention) to T2 (Month 2, mid-trial), T3 (Month 4, end of intervention) and T4 (Month 5, which is 1 month post-intervention follow-up)
Children's Liking of Snacks Low in Sweetness (SET 1 FOODS)
Tidsramme: At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention). Liking assessments of Set 1 and Set 2 foods were performed at separate laboratory visits.
Children's indicated liking of two sets of lower sweetness intervention snack foods (Set 1: Strawberry-banana yogurt, apple slices; Set 2: hummus and baby carrots), assessed on separate occasions. Using hedonic face scales, children indicated their like or dislike for each food. Liking data were not obtained during the COVID-19 lockdown. Set 1 foods were discontinued following the lockdown in a modified version of the protocol moved from in person visits to remote assessments. As such, outcome analyses of children's liking of snacks low in sweetness are reported on complete cases (Set 1 foods: n=40 children; Set 2 foods: n=54 children). This analysis shows the count of and percentage of children who liked SET 1 STRAWBERRY-BANANA YOGURT AND APPLE SLICES at the end of the intervention.
At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention). Liking assessments of Set 1 and Set 2 foods were performed at separate laboratory visits.
Children's Liking of Snacks Low in Sweetness (SET 2 FOODS)
Tidsramme: At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention). Liking assessments of Set 1 and Set 2 foods were performed at separate laboratory visits.
Children's indicated liking of two sets of lower sweetness intervention snack foods (Set 1: Strawberry-banana yogurt, apple slices; Set 2: hummus and baby carrots), assessed on separate occasions. Using hedonic face scales, children indicated their like or dislike for each food. Liking data were not obtained during the COVID-19 lockdown. Set 1 foods were discontinued following the lockdown in a modified version of the protocol moved from in person visits to remote assessments. As such, outcome analyses of children's liking of snacks low in sweetness are reported on complete cases (Set 1 foods: n=40 children; Set 2 foods: n=54 children). This analysis shows the number and percentage of children who liked SET 2 HUMMUS AND BABY CARROTS at the end of the intervention.
At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention). Liking assessments of Set 1 and Set 2 foods were performed at separate laboratory visits.
Children's Intake (g) of Snacks Low in Sweetness (SET 1 FOODS)
Tidsramme: At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention)
Children's intake of novel snacks in grams using weighed intake methods; higher intake and consummatory responses indicate greater acceptance. Children's ad libitum intake of two sets of lower sweetness intervention snack foods was assessed on separate occasion (Set 1: Strawberry-banana yogurt, apple slices; Set 2: hummus and baby carrots), a protocol that directly followed assessment of liking. Weighed intakes were used to measure children's intake of each food in grams. Intake data were not obtained during the COVID-19 lockdown. Set 1 foods were discontinued following the lockdown in a modified version of the protocol moved from in person visits to remote assessments. As such, outcome analyses of children's liking of snacks low in sweetness are reported on complete cases (Set 1 foods: n=40 children; Set 2 foods: n=54 children). This analysis presents INTAKE in GRAMS of SET 1 STRAWBERRY-BANANA YOGURT AND APPLE SLICES at the END OF TRIAL.
At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention)
Children's Intake (g) of Snacks Low in Sweetness (SET 2 FOODS)
Tidsramme: At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention)
Children's intake of novel snacks in grams using weighed intake methods; higher intake and consummatory responses indicate greater acceptance. Children's ad libitum intake of two sets of lower sweetness intervention snack foods was assessed on separate occasion (Set 1: Strawberry-banana yogurt, apple slices; Set 2: hummus and baby carrots), a protocol that directly followed assessment of liking. Weighed intakes were used to measure children's intake of each food in grams. Intake data were not obtained during the COVID-19 lockdown. Set 1 foods were discontinued following the lockdown in a modified version of the protocol moved from in person visits to remote assessments. As such, outcome analyses of children's liking of snacks low in sweetness are reported on complete cases (Set 1 foods: n=40 children; Set 2 foods: n=54 children). This analysis presents INTAKE in GRAMS of SET 2 HUMMUS and BABY CARROTS at the END OF TRIAL.
At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Children's Body Mass Index Z-scores (BMIz)
Tidsramme: At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention)
Children's height was measured in cm and weight in kg; these measures were used to calculate child BMI (kg/m2). Child BMI z-scores were calculated with CDC 2000 growth charts using the LMS method, which standardizes a child's BMI relative to a reference population of U.S. children of the same age and sex. The BMI z-score indicates how many standard deviations the child's BMI is above or below the CDC age- and sex-specific average, with higher positive values indicating higher relative body size compared to children of the same age and sex in the CDC reference population. This analysis compares child BMIz by arm at the END OF TRIAL.
At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention)
Children's Stable Isotope Biomarker of Added Sugar Intake
Tidsramme: From T1 (baseline Temple visit at start of intervention) to T3 (4 month visit=end of intervention)
Carbon stable isotopes were assessed using ratio mass spectrometry methods using hair samples collected at the start (T0) and end of 4-month intervention (T4).
From T1 (baseline Temple visit at start of intervention) to T3 (4 month visit=end of intervention)
Monitoring of Individual Differences in Parenting Feeding Styles
Tidsramme: T1 (baseline Temple visit at start of intervention)
Mothers will complete the 19-item Caregivers Feeding Styles Questionnaire [CFSQ]. Each item is scored from 1 (never) to 5 (always). Mean item scores were used to assess parental demandingness (12 items) and responsiveness (7 items), with a possible range of 1 to 5 for each scale where higher scores indicate higher levels of the construct. This measure was collected and checked at baseline to ensure that there were no differences by group/arm.
T1 (baseline Temple visit at start of intervention)
Monitoring of Individual Differences in Children's Appetitive Drive
Tidsramme: T1 (baseline Temple visit at start of intervention)
Mothers will complete the 26-item Children's Eating Behavior Questionnaire [CEBQ]. Each item is scored from 1 (never) to 5 (always) and are averaged and categorized into aspects of child eating (e.g., enjoyment of food, food responsiveness, satiety responsiveness, emotional overeating; emotional undereating, food fussiness); higher numbers reflect more of the behavior. This measure was collected and checked at baseline to ensure that there were no differences by group/arm.
T1 (baseline Temple visit at start of intervention)
Monitoring of Individual Differences in Children's Behavioral Activation
Tidsramme: T1 (baseline Temple visit at start of intervention)
Children's behavioral activation was measured using the Behavioral Activation Scale, a 20-item self-report questionnaire assessing children's sensitivity to reward and approach motivation across 3 subscales: drive (4 items), fun seeking (4 items), and reward responsiveness (5 items). Each question is answered using a 4-point Likert-type scale, with possible scores ranging from 1 (not true) -4 (very true). Scores for each of the three subscales are calculated as the sum of all items on the subscale, with higher scores indicating higher levels of the construct. Possible scores ranges for subscales are as follows: drive (4-16); fun seeking (4-16), and reward responsiveness (5-20). This measure was collected and checked at baseline to ensure that there were no differences by group/arm.
T1 (baseline Temple visit at start of intervention)
Monitoring of Individual Differences in Mothers' Palatable Eating Motivation
Tidsramme: T1 (baseline Temple visit at start of intervention)
Mothers will complete the 19-item Palatable Eating Motive Scales (PEMS) questionnaire; each item is scored from 1 (almost never/never exhibits behavior) to 5 (almost always/always exhibits behavior). Scores are averaged and categorized to reflect motives for intake of palatable foods (e.g., to socialize, cope, fit in or conform, for reward enhancement); higher numbers reflect more of the motivation.This measure was collected and checked at baseline to ensure that there were no differences by group/arm.
T1 (baseline Temple visit at start of intervention)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Konkordans av hårbiomarkør for tilsatt sukkerinntak blant mor-barn-dyader
Tidsramme: Forholdet mellom hårbiomarkørnivåer ved tidspunkt 0 (baseline tempelbesøk ved start av intervensjon) og ved T4 (4 måneders besøk = slutt på intervensjon)
Estimater av tilsatt sukkerinntak vil bli bestemt ved hjelp av stabile isotopforhold massespektrometrimetoder på hårprøver samlet inn fra mor og barn ved starten (T0) og slutten av 4-måneders intervensjon (T4) slutten av 4-måneders intervensjonsperiode (T4) å bestemme samsvar mellom mor-barn-dyader
Forholdet mellom hårbiomarkørnivåer ved tidspunkt 0 (baseline tempelbesøk ved start av intervensjon) og ved T4 (4 måneders besøk = slutt på intervensjon)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Julia Mennella, PhD, Monell Chemical Senses Center
  • Hovedetterforsker: Jennifer O Fisher, PhD, Temple University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. oktober 2018

Primær fullføring (Faktiske)

18. oktober 2024

Studiet fullført (Faktiske)

18. oktober 2024

Datoer for studieregistrering

Først innsendt

29. mai 2018

Først innsendt som oppfylte QC-kriteriene

13. august 2018

Først lagt ut (Faktiske)

15. august 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 24653
  • R01DC016616 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

dbGAP

IPD-delingstidsramme

2022 og for ett år

Tilgangskriterier for IPD-deling

Skal utvikles

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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