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Snacks, Smiles and Taste Preferences

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ClinicalTrials.gov Identifier: NCT03631992
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : June 3, 2019
Sponsor:
Collaborators:
Monell Chemical Senses Center
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Temple University

Tracking Information
First Submitted Date  ICMJE May 29, 2018
First Posted Date  ICMJE August 15, 2018
Last Update Posted Date June 3, 2019
Actual Study Start Date  ICMJE August 22, 2018
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • Change is being assessed in the children's level of taste preferences [ Time Frame: From timepoint 0 (baseline Monell 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) ]
    Level of tastant (sucrose, salt) most preferred as determined by Monell forced choice tracking method [range: 0.09 to 1.05 M] measured at baseline, 2 months, 4 months (end of intervention), 1 month postintervention
  • 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 or disliked as determined by lab-based forced-choice testing procedures; following grouping of snacks into liked and disliked, snacks will be ranked for most liked to most disliked [range: 4-6].
  • 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, as determined by lab-based testing feeding procedures which are digitally recorded and later analyzed for behavioral responses during feeding; higher intake and/or less facial expressions of distaste, greater acceptance
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03631992 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • 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)
  • 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
  • Change is being assessed in dietary intake of energy from added sugar and other sources [ 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 (g/day) will be determined from Automated Self-Administered Recall System (ASA24) and Diet History Questionnaire III completed by mothers for her child and herself, and adjusted for body weight of the individual (child, mother)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • Monitoring of waist and hip measurements [ 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 waist and hip circumference will be measured in cm; measurements will be combined to calculate waist-to-hip ratio
  • Taste receptor genotype [ Time Frame: At timepoint 0 (baseline Monell visit at start of intervention) ]
    Saliva with DNA will be collected for determination of allellic variants of known taste receptor genes to conduct exploratory analysis of genomic influence on sweet taste preference and response to intervention
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Snacks, Smiles and Taste Preferences
Official Title  ICMJE Downshifting Sweet Preference and Added Sugar Intake During Snacking
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The intervention group will receive snacks lower in added sugar and sweetness (children) and educational lessons on dental care, food labels, added sugar, and portion size (mothers) whereas the control group will receive typical snacks (children) and educational lessons on portion size, sleep, screen time, and physical activity (mothers). Control group will receive the educational lessons of the intervention group at the end of the trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Participants and outcome assessors will be blind to hypotheses and group assignment. Investigators will be blind to the group assignment during statistical analyses.
Primary Purpose: Basic Science
Condition  ICMJE Development, Child
Intervention  ICMJE
  • Behavioral: Low Sweet
    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.
  • Behavioral: Regular Sweet
    Children in sham comparator get typical snacks and mothers get education lessons on portion size, physical activity, sleep, and screen time.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Low Sweet
  • 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.
    Intervention: Behavioral: Regular Sweet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2018)
175
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jennifer O Fisher, PhD 215-707-0921 jofisher1@temple.edu
Contact: Lauren Dabritz, MS (267)-428-7883 lauren.dabritz@temple.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03631992
Other Study ID Numbers  ICMJE 24653
R01DC016616 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: dbGAP
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: 2022 and for one year
Access Criteria: To be developed
Responsible Party Temple University
Study Sponsor  ICMJE Temple University
Collaborators  ICMJE
  • Monell Chemical Senses Center
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators  ICMJE
Principal Investigator: Julia Mennella, PhD Monell Chemical Senses Center
Principal Investigator: Jennifer O Fisher, PhD Temple University
PRS Account Temple University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP