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
1.7 years until next milestone

Results Posted

Study results publicly available

June 30, 2026

Completed
Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

6 years

First QC Date

May 29, 2018

Results QC Date

January 12, 2026

Last Update Submit

June 4, 2026

Conditions

Keywords

ChildrenSugarTasteSnackingBiomarkerMothers

Outcome Measures

Primary Outcomes (6)

  • Children's Dietary Intake of Energy From Added Sugar (Tsp/d)

    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.

    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)

    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)

    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)

    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)

    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.

    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)

    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 Outcomes (6)

  • Children's Body Mass Index Z-scores (BMIz)

    At T1 (baseline visit at start of intervention) and T3 (4 month= end of intervention)

  • Children's Stable Isotope Biomarker of Added Sugar Intake

    From T1 (baseline Temple visit at start of intervention) to T3 (4 month visit=end of intervention)

  • Monitoring of Individual Differences in Parenting Feeding Styles

    T1 (baseline Temple visit at start of intervention)

  • Monitoring of Individual Differences in Children's Appetitive Drive

    T1 (baseline Temple visit at start of intervention)

  • Monitoring of Individual Differences in Children's Behavioral Activation

    T1 (baseline Temple visit at start of intervention)

  • +1 more secondary outcomes

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 (11)

  • 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
  • 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.

Results Point of Contact

Title
Jennifer Orlet Fisher, PhD
Organization
Temple University

Study Officials

  • Julia Mennella, PhD

    Monell Chemical Senses Center

    PRINCIPAL INVESTIGATOR
  • Jennifer O Fisher, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

June 30, 2026

Results First Posted

June 30, 2026

Record last verified: 2026-06

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