The Good Tastes Study: Young Children's Food Acceptance Patterns

NCT ID: NCT04549233

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-06

Study Completion Date

2018-01-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Children begin developing food acceptance and preferences during the first years of life, especially through repeated exposure and increased familiarity. Caregivers pay attention to the amounts of food that their children consume, and they also are sensitive to when their refuses to eat what is offered. This study will examine the interactions between caregivers and their infants when bitter vegetables are introduced to infants and toddlers. The goals for this study are to:

1. understand if masking bitterness with very low levels of sugar or salt may facilitate whether infants accept new vegetables;
2. understand if masking bitterness impacts caregivers' perceptions of infants' acceptance of new vegetables; and
3. understand the stress levels experienced by infants and caregivers throughout this process.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

During a single visit, four versions of a kale puree will be made with 1) no added sugar or sodium; 2) 1.2% added sugar; 3) 1.8% added sugar; and 4) 0.2% added sodium to mask bitterness. First, a familiar food will be offered to provide baseline data. Then each of the four versions of the novel kale puree will be offered to the infant by their caregiver, and the order the kale versions are presented will be randomized. The salt version will always be offered last to control for the effects of a very different taste exposure (salt vs. sweet) and to try to avoid any significant carryover effects of salt taste on sweet perception. Feeding interactions will be video recorded for behavioral coding of infant responses to each bite. Additionally, infant and caregiver heart rate and skin conductance will be monitored to assess physiological responses in each participant throughout the feeding interaction.

Several measures will be observed in order to test predictors of infant food acceptance, caregiver perceptions of infants' responses, and physiological responses in infants and caregivers. These include:

* Demographic measures
* Observed caregiver height and weight
* Observed infant length and weight
* Child developmental stage using Ages and Stages screening tool
* Caregiver neophobia
* Caregiver preferences for and intake of fruits and vegetables
* Infant feeding history and food experience
* Eating behaviors using the Child Eating Behavior Questionnaire for Toddlers
* Infant behavior using the Infant Behavior Questionnaire-Revised (Garstein \& Rothbart 2003 Infant Behav Dev)
* Caregiver feeding persistence

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Food Neophobia Parenting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Term birth (gestational age \> 37 weeks);
* Experience with at least 1 complementary food (e.g., infant cereal);
* Caregivers who are \> 18 y and \< 51 y of age;
* Caregivers who live within 75 miles of the University of Colorado-Denver campus.

Exclusion Criteria

* Has genetic disorders or developmental disabilities as these conditions often result in feeding difficulties;
* Has a reported illness or metabolic disorder that would affect food intake (e.g., significant history of allergies);
* Born prematurely (\< 37 weeks gestation);
* Caregivers who are younger than 18 y of age or \> 51 y;
* Caregivers who live more than 75 miles from the University of Colorado-Denver campus;
* Caregivers who do not read and speak English.
Minimum Eligible Age

6 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Sugar Association

UNKNOWN

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susan L Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

UC Denver

Kameron J Moding, PhD

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Colorado Denver

Aurora, Colorado, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 11693591 (View on PubMed)

Squires J, Bricker D, Potter L. Revision of a parent-completed development screening tool: Ages and Stages Questionnaires. J Pediatr Psychol. 1997 Jun;22(3):313-28. doi: 10.1093/jpepsy/22.3.313.

Reference Type BACKGROUND
PMID: 9212550 (View on PubMed)

Ham J, Tronick E. Infant resilience to the stress of the still-face: infant and maternal psychophysiology are related. Ann N Y Acad Sci. 2006 Dec;1094:297-302. doi: 10.1196/annals.1376.038.

Reference Type BACKGROUND
PMID: 17347365 (View on PubMed)

Johnson SL, Moding KJ, Grimm KJ, Flesher AE, Bakke AJ, Hayes JE. Infant and Toddler Responses to Bitter-Tasting Novel Vegetables: Findings from the Good Tastes Study. J Nutr. 2021 Oct 1;151(10):3240-3252. doi: 10.1093/jn/nxab198.

Reference Type DERIVED
PMID: 34191021 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15-2437

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Eating Behavior in Children
NCT00320177 COMPLETED
Infant Environment Study
NCT02936284 COMPLETED NA