- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03631992
Snacks, Smiles and Taste Preferences
October 18, 2024 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
-
Philadelphia, Pennsylvania, United States, 19104
- Monell Chemical Senses Center
-
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.
|
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.
|
Children in sham comparator get typical snacks and mothers get education lessons on portion size, physical activity, sleep, and screen time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change is being assessed in the children's liking of snacks low in sweetness
Time Frame: From timepoint 0 (baseline Temple visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay)
|
Children's grouping of the taste of novel snacks as liked, ok, or disliked as determined by lab-based measurements of liking using a picture-based 3-point hedonic scale depicting "yummy", "yucky", and "just-okay" responses; following the grouping of snacks into these categories, snacks will be ranked for most liked to most disliked [range: 4-6].
|
From timepoint 0 (baseline Temple visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay)
|
|
Change is being assessed in the children's intake of snacks low in sweetness
Time Frame: From timepoint 0 (baseline Temple visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month= end of intervention) and T5 (5 month which is 1 month, post-intervention delay)
|
Children's intake of novel snacks in grams using weighed intake methods and behavioral parameters of intake from digital recordings; higher intake and consummatory responses indicate greater acceptance.
|
From timepoint 0 (baseline Temple visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month= end of intervention) and T5 (5 month which is 1 month, post-intervention delay)
|
|
Change is being assessed in dietary intake of energy from added sugar
Time Frame: From timepoint 0 (baseline Temple visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay)
|
Dietary intake (kcal/d) will be determined from Automated Self-Administered Recall System (ASA24) completed by mothers for her child and herself.
|
From timepoint 0 (baseline Temple visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change is being assessed in levels of hair biomarker for added sugar intake
Time Frame: From timepoint 0 (baseline Temple visit at start of intervention) to 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 at the start (T0) and end of 4-month intervention (T4)
|
From timepoint 0 (baseline Temple visit at start of intervention) to T4 (4 month visit=end of intervention)
|
|
Change is being assessed in liking-based dietary intake survey
Time Frame: From timepoint 0 (baseline Temple visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay)
|
Dietary intake of foods as determined by measurements of the degree of dislike or like for a variety of foods and beverages (e.g., sweet/fat, fruit, vegetables) as well as experiences and activities; range: -100 (maximal dislike) to 100 (maximal like)].
The items in a given category (e.g., fruits; sweets/fats; healthy foods) are combined and averaged [range: -100 to 100; higher numbers reflect greater liking and intake].
The preschool adapted liking survey (PALS) is used for children and the adult liking survey (ALS) is used for mothers
|
From timepoint 0 (baseline Temple visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay)
|
|
Monitoring of individual differences in parenting feeding styles
Time Frame: From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay)
|
Mothers will complete the 19-item Child Feeding Styles and Practices Questionnaire [CFSQ].
Each item is scored from 1 (never) to 5 (always).
Scores are averaged and categorized into one of four feeding styles: authoritative, authoritarian, indulgent and uninvolved; higher scores represent more of the feeding style
|
From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay)
|
|
Monitoring of individual differences in children's appetitive drive
Time Frame: From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay)
|
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
|
From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay)
|
|
Monitoring of individual differences in children's palatable eating motivation
Time Frame: From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay)
|
Mothers will complete the 19-item Kids Palatable Eating Motive Scales (KPEMS) questionnaire; each item is scored from 1 (child almost never/never exhibits behavior) to 5 (child 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
|
From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay)
|
|
Monitoring of individual differences in mothers' palatable eating motivation
Time Frame: From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay)
|
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
|
From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month, end of intervention) and T5 (5 month, which is 1 month post-intervention delay)
|
|
Monitoring of weight
Time Frame: From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month= end of intervention) and T5 (5 month which is 1 month, post-intervention delay)
|
Children's weight will be measured in kg; these measures will be converted to weight for age Z scores which provide measures of anthropometry adjusted age and sex.
|
From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month= end of intervention) and T5 (5 month which is 1 month, post-intervention delay)
|
|
Monitoring of height
Time Frame: From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month= end of intervention) and T5 (5 month which is 1 month, post-intervention delay)
|
Children's height will be measured in cm; these measures will be converted to height for age Z scores which provide measures of anthropometry adjusted age and sex.
|
From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month= end of intervention) and T5 (5 month which is 1 month, post-intervention delay)
|
|
Monitoring of body mass index
Time Frame: From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month= end of intervention) and T5 (5 month which is 1 month, post-intervention delay)
|
Children's height will be measured in cm and weight in kg; these measures will be combined to determine BMI (kg/m2) and then converted to BMI Z scores which provide measures of anthropometry adjusted age and sex.
|
From timepoint 0 (baseline visit at start of intervention) to T1 (1 month), T2 (2 month), T3 (3 month), T4 (4 month= end of intervention) and T5 (5 month which is 1 month, post-intervention delay)
|
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
|
Relationship between hair biomarker levels at timepoint 0 (baseline Temple visit at start of intervention) and at T4 (4 month visit=end of intervention)
|
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.
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)
October 22, 2024
Last Update Submitted That Met QC Criteria
October 18, 2024
Last Verified
December 1, 2023
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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