NCT04549233

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 6, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

August 18, 2020

Last Update Submit

September 8, 2020

Conditions

Keywords

Infant FeedingToddler FeedingComplementary FeedingFood AcceptanceParenting

Outcome Measures

Primary Outcomes (2)

  • Infant rate of acceptance of kale puree

    Acceptance is measured using an adaptation of the Feeding Infants: Behavior and Facial Expression Coding System (FIBFECS) on a 4-point scale from 0-3 where 0 = refusal and 3 = early acceptance of food. (Hetherington et al. 2016 Food Qual Prefer)

    Baseline

  • Infant responses to kale puree

    Responses are measured using an adaptation of the Feeding Infants: Behavior and Facial Expression Coding System (FIBFECS). Positive behaviors include leaning forward, and negative behaviors include turning head away, getting fussy, and pushing the spoon away. (Hetherington et al. 2016 Food Qual Prefer)

    Baseline

Secondary Outcomes (8)

  • Caregivers' perceived ratings of infant liking of kale

    Baseline

  • Caregivers' intentions to offer kale again

    Baseline

  • Infant mean heart rate reactivity to kale exposure

    Baseline

  • Infant amplitude of skin conductance in response to kale exposure

    Baseline

  • Caregiver mean heart rate reactivity to infant exposure to kale

    Baseline

  • +3 more secondary outcomes

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants and caregivers who live in the Denver area will be recruited using advertising flyers, emails sent through a university listserv and parent email distribution, and word of mouth.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (4)

  • 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
  • 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.

    PMID: 9212550BACKGROUND
  • 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.

    PMID: 17347365BACKGROUND
  • 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.

MeSH Terms

Conditions

Avoidant Restrictive Food Intake Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Susan L Johnson, PhD

    UC Denver

    PRINCIPAL INVESTIGATOR
  • Kameron J Moding, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2020

First Posted

September 16, 2020

Study Start

July 6, 2017

Primary Completion

January 7, 2018

Study Completion

January 7, 2018

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations