Preferencias de bocadillos, sonrisas y sabor
4 de junio de 2026 actualizado por: Temple University
Reducir la preferencia por lo dulce y la ingesta de azúcar agregada durante la merienda
El estudio de investigación está diseñado para determinar si la aceptación de los niños de bocadillos bajos en azúcar, el nivel preferido de sabor dulce y salado y la ingesta dietética de azúcares agregados cambia después de la exposición repetida a bocadillos con menos dulzura en comparación con el grupo de control.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Este es un estudio longitudinal, aleatorizado, dentro y entre sujetos de niños y sus madres para determinar si la exposición repetida de los niños a refrigerios bajos en dulzura y las lecciones educativas de las madres sobre salud dental y nutrición (grupo de intervención) afecta la aceptación de los niños de alimentos bajos en azúcar. refrigerios, el nivel más preferido de sabor dulce y salado, y la ingesta dietética de azúcares agregados en comparación con el grupo de control.
Tipo de estudio
Intervencionista
Inscripción (Actual)
172
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Monell Chemical Senses Center
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Philadelphia, Pennsylvania, Estados Unidos, 19140
- Temple University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
3 años a 6 años (Niño)
Acepta Voluntarios Saludables
Sí
Descripción
Criterios de inclusión:
- Madre de habla inglesa de 18 años o más.
- La madre tiene la responsabilidad principal del cuidado del niño elegible
- La madre tiene la responsabilidad principal de alimentar al niño elegible
- La madre es responsable de comprar alimentos para la familia.
- La madre debe estar dispuesta a abstenerse de comer alimentos y bebidas con alto contenido de azúcares añadidos en presencia del niño elegible durante la duración del estudio.
Criterio de exclusión:
- El niño está en una guardería o escuela de día completo
- El niño está actualmente en una dieta especial (p. programas de control de peso)
- El niño tiene alergias alimentarias graves (p. gluten, maní)
- El niño tiene condiciones médicas que se sabe que afectan el crecimiento o la alimentación (p. diabetes, fibrosis quística)
- La madre es fumadora actual.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Bajo dulce
A los niños del grupo de intervención se les proporcionarán meriendas diarias bajas en azúcar agregada y dulzura, y sus madres recibirán lecciones educativas sobre cuidado dental, lectura de etiquetas de alimentos y nutrición que respaldan los objetivos de reducir la exposición a "dulces" y la ingesta de azúcar agregada.
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Los niños del grupo experimental reciben exposición repetida a refrigerios más bajos en azúcar y las madres reciben lecciones educativas sobre el cuidado dental, la lectura de las etiquetas de los alimentos, el tamaño de las porciones y la nutrición.
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Comparador falso: Dulce Regular
A los niños en el grupo de control dulce regular se les proporcionarán refrigerios comunes para los niños de esta edad y las madres recibirán lecciones educativas sobre el tamaño de las porciones, la actividad física, el sueño, el tiempo frente a la pantalla y, al final de la prueba, el cuidado dental.
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Los niños en el comparador simulado obtienen refrigerios típicos y las madres reciben lecciones educativas sobre el tamaño de las porciones, la actividad física, el sueño y el tiempo frente a la pantalla.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Children's Dietary Intake of Energy From Added Sugar (Tsp/d)
Periodo de tiempo: 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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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.
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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)
Periodo de tiempo: 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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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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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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 Intake (g) of Snacks Low in Sweetness (SET 1 FOODS)
Periodo de tiempo: At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention)
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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)
Periodo de tiempo: 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.
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At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Children's Body Mass Index Z-scores (BMIz)
Periodo de tiempo: At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention)
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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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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T1 (baseline Temple visit at start of intervention)
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Monitoring of Individual Differences in Children's Appetitive Drive
Periodo de tiempo: T1 (baseline Temple visit at start of intervention)
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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.
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T1 (baseline Temple visit at start of intervention)
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Monitoring of Individual Differences in Children's Behavioral Activation
Periodo de tiempo: T1 (baseline Temple visit at start of intervention)
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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
Periodo de tiempo: T1 (baseline Temple visit at start of intervention)
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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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Concordancia del biomarcador capilar para la ingesta de azúcares añadidos entre díadas madre-hijo
Periodo de tiempo: Relación entre los niveles de biomarcadores capilares en el punto de tiempo 0 (visita inicial al templo al comienzo de la intervención) y en T4 (visita de 4 meses = final de la intervención)
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Las estimaciones de la ingesta de azúcar añadida se determinarán mediante métodos de espectrometría de masas de relación de isótopos estables en muestras de cabello recolectadas de la madre y el niño al comienzo (T0) y al final de la intervención de 4 meses (T4) al final del período de intervención de 4 meses (T4) para determinar la concordancia entre díadas madre-hijo
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Relación entre los niveles de biomarcadores capilares en el punto de tiempo 0 (visita inicial al templo al comienzo de la intervención) y en T4 (visita de 4 meses = final de la intervención)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Julia Mennella, PhD, Monell Chemical Senses Center
- Investigador principal: Jennifer O Fisher, PhD, Temple University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
9 de octubre de 2018
Finalización primaria (Actual)
18 de octubre de 2024
Finalización del estudio (Actual)
18 de octubre de 2024
Fechas de registro del estudio
Enviado por primera vez
29 de mayo de 2018
Primero enviado que cumplió con los criterios de control de calidad
13 de agosto de 2018
Publicado por primera vez (Actual)
15 de agosto de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 24653
- R01DC016616 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
dbGAP
Marco de tiempo para compartir IPD
2022 y por un año
Criterios de acceso compartido de IPD
Para ser desarrollado
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .