- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03631992
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
Intervensjon / Behandling
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
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Philadelphia, Pennsylvania, Forente stater, 19104
- Monell Chemical Senses Center
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Philadelphia, Pennsylvania, Forente stater, 19140
- Temple University
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-
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 |
|---|---|
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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.
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Barn i den eksperimentelle gruppen får gjentatt eksponering for mindre søte snacks og mødre får opplæring i tannpleie, lesing av matetiketter, porsjonsstørrelse og ernæring.
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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.
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Barn i sham-komparator får typiske snacks og mødre får opplæring i porsjonsstørrelse, fysisk aktivitet, søvn og skjermtid.
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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)
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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.
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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)
|
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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.
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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.
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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.
|
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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.
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At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention)
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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.
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At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention)
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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)
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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).
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From T1 (baseline Temple visit at start of intervention) to T3 (4 month visit=end of intervention)
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Monitoring of Individual Differences in Parenting Feeding Styles
Tidsramme: T1 (baseline Temple visit at start of intervention)
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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)
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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)
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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.
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T1 (baseline Temple visit at start of intervention)
|
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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.
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T1 (baseline Temple visit at start of intervention)
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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)
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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
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Forholdet mellom hårbiomarkørnivåer ved tidspunkt 0 (baseline tempelbesøk ved start av intervensjon) og ved T4 (4 måneders besøk = slutt på intervensjon)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
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
- Wardle J, Guthrie CA, Sanderson S, Rapoport L. Development of the Children's Eating Behaviour Questionnaire. J Child Psychol Psychiatry. 2001 Oct;42(7):963-70. doi: 10.1111/1469-7610.00792.
- Mennella JA, Lukasewycz LD, Griffith JW, Beauchamp GK. Evaluation of the Monell forced-choice, paired-comparison tracking procedure for determining sweet taste preferences across the lifespan. Chem Senses. 2011 May;36(4):345-55. doi: 10.1093/chemse/bjq134. Epub 2011 Jan 12.
- Nash SH, Kristal AR, Hopkins SE, Boyer BB, O'Brien DM. Stable isotope models of sugar intake using hair, red blood cells, and plasma, but not fasting plasma glucose, predict sugar intake in a Yup'ik study population. J Nutr. 2014 Jan;144(1):75-80. doi: 10.3945/jn.113.182113. Epub 2013 Nov 6.
- Mennella JA, Finkbeiner S, Lipchock SV, Hwang LD, Reed DR. Preferences for salty and sweet tastes are elevated and related to each other during childhood. PLoS One. 2014 Mar 17;9(3):e92201. doi: 10.1371/journal.pone.0092201. eCollection 2014.
- Vandeweghe L, Verbeken S, Moens E, Vervoort L, Braet C. Strategies to improve the Willingness to Taste: The moderating role of children's Reward Sensitivity. Appetite. 2016 Aug 1;103:344-352. doi: 10.1016/j.appet.2016.04.017. Epub 2016 Apr 19.
- Hughes SO, Power TG, Orlet Fisher J, Mueller S, Nicklas TA. Revisiting a neglected construct: parenting styles in a child-feeding context. Appetite. 2005 Feb;44(1):83-92. doi: 10.1016/j.appet.2004.08.007. Epub 2004 Nov 13.
- Sharafi M, Rawal S, Fernandez ML, Huedo-Medina TB, Duffy VB. Taste phenotype associates with cardiovascular disease risk factors via diet quality in multivariate modeling. Physiol Behav. 2018 Oct 1;194:103-112. doi: 10.1016/j.physbeh.2018.05.005. Epub 2018 May 8.
- Martignon S, Gonzalez MC, Tellez M, Guzman A, Quintero IK, Saenz V, Martinez M, Mora A, Espinosa LF, Castiblanco GA. Schoolchildren's tooth brushing characteristics and oral hygiene habits assessed with video-recorded sessions at school and a questionnaire. Acta Odontol Latinoam. 2012;25(2):163-70.
- Mennella JA, Pepino MY, Lehmann-Castor SM, Yourshaw LM. Sweet preferences and analgesia during childhood: effects of family history of alcoholism and depression. Addiction. 2010 Apr;105(4):666-75. doi: 10.1111/j.1360-0443.2009.02865.x. Epub 2010 Feb 9.
- Mennella JA, Coffman DL, Merchan MT, Croce CM, Smethers AD, Fisher JO. Exposure to low-sweet snacks and caregiver nutritional and dental health education lowered children's added sugar intake: a randomized controlled trial. Am J Clin Nutr. 2026 Mar 13:101272. doi: 10.1016/j.ajcnut.2026.101272. Online ahead of print.
- Smethers AD, Fisher JO, Carney EM, Coffman DL, Mennella JA. Carbon stable isotope values in hair are associated with added sugar intake in adults but not young children: a cross-sectional study. Am J Clin Nutr. 2025 Apr;121(4):900-909. doi: 10.1016/j.ajcnut.2025.02.013. Epub 2025 Feb 18.
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. .