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

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.

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

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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