NCT03631992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 9, 2018

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2024

Completed
Last Updated

October 22, 2024

Status Verified

December 1, 2023

Enrollment Period

6 years

First QC Date

May 29, 2018

Last Update Submit

October 18, 2024

Conditions

Keywords

ChildrenSugarTasteSnackingBiomarkerMothers

Outcome Measures

Primary Outcomes (3)

  • Change is being assessed in the children's liking of snacks low in sweetness

    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

    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

    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 Outcomes (9)

  • Change is being assessed in levels of hair biomarker for added sugar intake

    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

    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

    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

    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

    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)

  • +4 more secondary outcomes

Other Outcomes (1)

  • Concordance of hair biomarker for added sugar intake 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)

Study Arms (2)

Low Sweet

EXPERIMENTAL

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.

Behavioral: Low Sweet

Regular Sweet

SHAM COMPARATOR

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.

Behavioral: Regular Sweet

Interventions

Low SweetBEHAVIORAL

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.

Low Sweet
Regular SweetBEHAVIORAL

Children in sham comparator get typical snacks and mothers get education lessons on portion size, physical activity, sleep, and screen time.

Regular Sweet

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (10)

  • 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.

    PMID: 21227904BACKGROUND
  • 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.

    PMID: 24198311BACKGROUND
  • 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.

    PMID: 24637844BACKGROUND
  • 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.

    PMID: 11693591BACKGROUND
  • 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.

    PMID: 27103060BACKGROUND
  • 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.

    PMID: 15604035BACKGROUND
  • 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.

    PMID: 29746892BACKGROUND
  • 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.

    PMID: 23230636BACKGROUND
  • 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.

    PMID: 20148789BACKGROUND
  • 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 Officials

  • Julia Mennella, PhD

    Monell Chemical Senses Center

    PRINCIPAL INVESTIGATOR
  • Jennifer O Fisher, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants and outcome assessors will be blind to hypotheses and group assignment. Investigators will be blind to the group assignment during statistical analyses.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2018

First Posted

August 15, 2018

Study Start

October 9, 2018

Primary Completion

October 18, 2024

Study Completion

October 18, 2024

Last Updated

October 22, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

dbGAP

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
2022 and for one year
Access Criteria
To be developed

Locations