- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03631992
Snacks, Smiles and Taste Preferences
June 4, 2026 updated by: Temple University
Downshifting Sweet Preference and Added Sugar Intake During Snacking
The research study is designed is to determine whether children's acceptance of low sugar snacks, most preferred level of sweet and salty taste, and dietary intake of added sugars changes after repeated exposure to snacks lower in sweetness when compared to the control group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a longitudinal, randomized, within- and between- subject study of children and their mothers to determine whether children's repeated exposure to snacks lower in sweetness and mothers' educational lessons about dental health and nutrition (intervention group) affects children's acceptance of low sugar snacks, most preferred level of sweet and salty taste, and dietary intake of added sugars when compared to the control group.
Study Type
Interventional
Enrollment (Actual)
172
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Monell Chemical Senses Center
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Philadelphia, Pennsylvania, United States, 19140
- Temple University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 6 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- English speaking mother 18 years or older
- Mother has primary responsibility for the eligible child's care
- Mother has primary responsibility for feeding the eligible child
- Mother is responsible for purchasing food for the family
- Mother must be willing to refrain from eating food and beverages high in added sugars in the eligible child's presence for the duration of the study
Exclusion Criteria:
- Child is in full-day daycare or school
- Child is currently on a special diet (e.g. weight management programs)
- Child has severe food allergies (e.g. gluten, peanuts)
- Child has medical conditions know to affect growth or eating (e.g. diabetes, cystic fibrosis)
- Mother is a current smoker
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low Sweet
Children in intervention group will be provided with daily snacks lower in added sugar and sweetness and their mothers will receive educational lessons on dental care, reading food labels, and nutrition that support the goals of reducing "sweet" exposure and added sugar intake.
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Children in the experimental group get repeated exposure to lower sweet snacks and mothers get education lessons on dental care, reading food labels, portion size, and nutrition.
|
|
Sham Comparator: Regular Sweet
Children in the regular sweet control group will be provided with common snacks fed to children of this age and mothers will be given education lessons on portion size, physical activity, sleep, screen time and, at the end of the trial, dental care.
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Children in sham comparator get typical snacks and mothers get education lessons on portion size, physical activity, sleep, and screen time.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's Dietary Intake of Energy From Added Sugar (Tsp/d)
Time Frame: 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.
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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)
|
|
Caregiver's Dietary Intake of Energy From Added Sugar (Tsp/d)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
|
|
Children's Intake (g) of Snacks Low in Sweetness (SET 2 FOODS)
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's Body Mass Index Z-scores (BMIz)
Time Frame: 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)
|
|
Children's Stable Isotope Biomarker of Added Sugar Intake
Time Frame: 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
Time Frame: 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
Time Frame: 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.
|
T1 (baseline Temple visit at start of intervention)
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Monitoring of Individual Differences in Children's Behavioral Activation
Time Frame: 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
Time Frame: 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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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Concordance of hair biomarker for added sugar intake among mother-child dyads
Time Frame: Relationship between hair biomarker levels at timepoint 0 (baseline Temple visit at start of intervention) and at T4 (4 month visit=end of intervention)
|
Estimates of added sugar intake will be determined via stable isotope ratio mass spectrometry methods on hair samples collected from mother and child at the start (T0) and end of 4-month intervention (T4) end of the 4-month intervention period (T4) to determine concordance among mother-child dyads
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Relationship between hair biomarker levels at timepoint 0 (baseline Temple visit at start of intervention) and at T4 (4 month visit=end of intervention)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Julia Mennella, PhD, Monell Chemical Senses Center
- Principal Investigator: Jennifer O Fisher, PhD, Temple University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 9, 2018
Primary Completion (Actual)
October 18, 2024
Study Completion (Actual)
October 18, 2024
Study Registration Dates
First Submitted
May 29, 2018
First Submitted That Met QC Criteria
August 13, 2018
First Posted (Actual)
August 15, 2018
Study Record Updates
Last Update Posted (Actual)
June 30, 2026
Last Update Submitted That Met QC Criteria
June 4, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 24653
- R01DC016616 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
dbGAP
IPD Sharing Time Frame
2022 and for one year
IPD Sharing Access Criteria
To be developed
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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