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Snacks, smil og smagspræferencer

4. juni 2026 opdateret af: Temple University

Nedgearing af søde præferencer og tilsat sukkerindtag under snacks

Forskningsstudiet er designet til at afgøre, om børns accept af snacks med lavt sukkerindhold, det mest foretrukne niveau af sød og salt smag og kostens indtag af tilsat sukker ændrer sig efter gentagen eksponering for snacks med lavere sødme sammenlignet med kontrolgruppen.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Dette er en longitudinel, randomiseret undersøgelse af børn og deres mødre inden for og mellem emner for at afgøre, om børns gentagne eksponering for snacks med lavere sødme og mødres undervisningslektioner om tandsundhed og ernæring (interventionsgruppe) påvirker børns accept af lavt sukkerindhold. snacks, det mest foretrukne niveau af sød og salt smag og kostindtag af tilsat sukker sammenlignet med kontrolgruppen.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

172

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Monell Chemical Senses Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19140
        • Temple University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

3 år til 6 år (Barn)

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusionskriterier:

  • Engelsktalende mor 18 år eller ældre
  • Mor har det primære ansvar for det berettigede barns pasning
  • Mor har det primære ansvar for at fodre det berettigede barn
  • Mor er ansvarlig for indkøb af mad til familien
  • Mor skal være villig til at afholde sig fra at spise mad og drikke med højt indhold af tilsat sukker i det berettigede barns tilstedeværelse i hele undersøgelsens varighed

Ekskluderingskriterier:

  • Barnet er i dagpleje eller skole
  • Barnet er i øjeblikket på en særlig diæt (f.eks. vægtstyringsprogrammer)
  • Barnet har svær fødevareallergi (f. gluten, jordnødder)
  • Barn har medicinske tilstande, der vides at påvirke vækst eller spisning (f. diabetes, cystisk fibrose)
  • Mor er en nuværende ryger

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Lav sød
Børn i interventionsgruppen vil få daglige snacks med et lavt indhold af tilsat sukker og sødme, og deres mødre vil modtage undervisningstimer om tandpleje, læsning af fødevareetiketter og ernæring, der understøtter målene om at reducere "sød" eksponering og tilsat sukkerindtag.
Børn i forsøgsgruppen får gentagen eksponering for mindre søde snacks, og mødre får undervisning i tandpleje, læsning af fødevareetiketter, portionsstørrelse og ernæring.
Sham-komparator: Almindelig sød
Børn i den almindelige søde kontrolgruppe vil blive forsynet med almindelige snacks til børn i denne alder, og mødre vil få undervisning i portionsstørrelse, fysisk aktivitet, søvn, skærmtid og, i slutningen af ​​forsøget, tandpleje.
Børn i sham-komparator får typiske snacks, og mødre får undervisning i portionsstørrelse, fysisk aktivitet, søvn og skærmtid.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
Tidsramme
Overensstemmelse mellem hårbiomarkør for tilsat sukkerindtag blandt mor-barn-dyader
Tidsramme: Forholdet mellem hårbiomarkørniveauer på tidspunkt 0 (baseline tempelbesøg ved start af intervention) og ved T4 (4 måneders besøg = afslutning af intervention)
Estimater af tilsat sukkerindtag vil blive bestemt via stabile isotopforhold massespektrometrimetoder på hårprøver indsamlet fra mor og barn ved starten (T0) og slutningen af ​​4-måneders intervention (T4) slutningen af ​​4-måneders interventionsperiode (T4) at bestemme overensstemmelse mellem mor-barn-dyader
Forholdet mellem hårbiomarkørniveauer på tidspunkt 0 (baseline tempelbesøg ved start af intervention) og ved T4 (4 måneders besøg = afslutning af intervention)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

9. oktober 2018

Primær færdiggørelse (Faktiske)

18. oktober 2024

Studieafslutning (Faktiske)

18. oktober 2024

Datoer for studieregistrering

Først indsendt

29. maj 2018

Først indsendt, der opfyldte QC-kriterier

13. august 2018

Først opslået (Faktiske)

15. august 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

dbGAP

IPD-delingstidsramme

2022 og i et år

IPD-delingsadgangskriterier

Skal udvikles

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

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