Feeding BehaviorNCT05639361
Healthy Starts: Repeated Exposure Pilot
An observational study of Feeding Behavior, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Decades of research have established that providing repeated exposure to new foods is the most robust strategy for promoting children's acceptance of new foods (1). However, there is little guidance on how best to translate this recommendation into everyday family life about how often to introduce children to new… Read more about this study
- Who is it for?
- Ages 9 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Feeding Behavior
- What is being tested?
- Repeated Exposure
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population includes healthy, typically-developing infants aged 9-12 months and a healthy primary caregiver living in the Denver, CO metro area.
Who may be able to join
- Adult caregivers ≥ 18 years of age
- Infants 9-12 months of age
- Infants born ≥ 37 weeks gestational age
- Infants have not been diagnosed with developmental delays, congenital or other medical conditions that may interfere with feeding (e.g., dysphagia).
Who cannot join
- Caregivers younger than 18 years of age
- Caregivers do not speak English or Spanish
- Caregivers do not live in the Denver Metro area
- Infants who were born < 37 weeks gestational age
- Infants have been diagnosed with a developmental delay or congenital or medical condition that may interfere with feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Katherine J Barrett, PhD, 303-724-2922, katherine.barrett@cuanschutz.edu
About this study
Official title: Healthy Starts: Pacing of Children's Introduction to New Plant-Based Foods
Decades of research have established that providing repeated exposure to new foods is the most robust strategy for promoting children's acceptance of new foods (1). However, there is little guidance on how best to translate this recommendation into everyday family life about how often to introduce children to new foods. We propose to conduct a proof-of-concept randomized trial that will evaluate three different schedules of repeated exposure to a novel vegetable, which will help to identify the optimal "pacing" of repeated exposure to promote children's acceptance (i.e., intake) of new vegetables. Here we define "pacing" as how often (every day, every few days, etc.) and across what interval of time (days, weeks, months) repeated exposure is effective for infants to learn to accept a novel food.
Read the detailed description
Child acceptance of a novel vegetable will be assessed at 4 periodic consumption tests. Participants will visit the Children's Eating Laboratory where caregivers will offer their infants the novel vegetable in the format of their choice (pureed, mashed, or cut into small pieces). These visits will occur at: 1) baseline; 2) 2 weeks to obtain an interim measure of acceptance; 3) 6 weeks to measure acceptance at the end of the exposure period, and 4) 3 months (approximately 6 weeks from the end of the exposure period) to measure longer-term acceptance. Caregivers will be asked not to feed their child less than 90 minutes before arriving for their visit, so that their child will be hungry when they are being offered food. The feeding sessions during each visit will be video recorded. Child acceptance of the novel vegetable will be measured by intake (consumption in grams) and rate of acceptance. The vegetable will be weighed before and after it is offered to calculate intake by the child. The videos will be coded by trained coders trained to reliability, who will code for the child's rate of acceptance of the novel food, which ranges from rejection of the food to eager anticipation of the bite (Hetherington et al. 2016 Food Qual Prefer; Nekitsing et al. 2016 Food Qual Prefer), and for child and caregiver behaviors (Barrett et al. 2021 Curr Dev Nutr).
Caregivers will be provided the novel vegetable to offer their child at home. They will be asked to offer a small taste (2 small bites' worth or up to 3 rejections) at the intervals specified above. During the in-home exposure period, caregivers will be asked to keep a brief log of each offer of the novel food. These logs will include the method of food preparation (pureed or mashed vs. whole or in small pieces), whether the caregiver fed the child or the child fed themselves, whether the child tasted the food, and the caregiver's perception of the child's liking of the vegetable.
- Conditions
- Feeding Behavior
- Being tested
- Repeated Exposure
- Keywords
- Repeated Exposure, Infant/Toddler Feeding, Eating Behaviors
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated ExposureBehavioural
Caregivers will be asked to offer a novel vegetable to their infant/toddler 10 times at home according to the schedule of repeated exposure to which they are randomized.
| Study group | Role | What they receive |
|---|---|---|
| Standard Condensed | Will complete a "traditional" schedule of 10 exposures over a 2-week period followed by a one-month "break" period before the final assessment. Because this schedule of exposure has been used most frequently in repeated exposure studies, this group will serve as the reference group. Receives: Behavioral: Repeated Exposure | |
| Periodic | Will complete a schedule of 5 exposures over a 2-week period, followed by a 2-week break, and then another 5 exposures over an additional 2-week period. Receives: Behavioral: Repeated Exposure | |
| Extended | Will complete a schedule of 10 exposures over a continuous 6-week period of time (approximately one exposure every 3-5 days). Receives: Behavioral: Repeated Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Consumption of the Novel Vegetable (Intervention Midpoint)
Change in the amount of novel food consumed (in g)
Measured: Baseline, Follow-up 1
Change in Consumption of the Novel Vegetable (Intervention Endpoint)
Change in the amount of novel food consumed (in g)
Measured: Baseline, Follow-up 2
Change in Consumption of the Novel Vegetable (Post-Intervention)
Change in the amount of novel food consumed (in g)
Measured: Baseline, Follow-up 3
Change in Rate of Acceptance of the Novel Vegetable (Intervention Midpoint)
Difference in mean rate of acceptance between between follow-up and baseline. 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)
Measured: Baseline, Follow-up 1
Change in Rate of Acceptance of the Novel Vegetable (Intervention Endpoint)
Difference in mean rate of acceptance between between end of intervention and baseline. 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)
Measured: Baseline, Follow-up 2
Change in Rate of Acceptance of the Novel Vegetable (Post-Intervention)
Difference in mean rate of acceptance between between post-intervention follow-up and baseline. 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)
Measured: Baseline, Follow-up 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Apr 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Feeding BehaviorStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, Vitamix Foundation
- Responsible party
- Sponsor
- Investigators
- Katherine J Barrett, PhD, Principal investigator, University of Colorado, DenverSusan L Johnson, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639361
- Sponsor's protocol ID
- 22-1618
- Status last verified
- May 2023
- First submitted
- 21 Nov 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be available upon request to the Principal Investigator
Publications
Hetherington MM, Madrelle J, Nekitsing C, Barends C, de Graaf C, Morgan S, Parrott H, Weenen H. Developing a novel tool to assess liking and wanting in infants at the time of complementary feeding - The Feeding Infants: Behaviour and Facial Expression Coding System (FIBFECS). Food Quality and Preference. 2016; 48: 238-250.
Nekitsing C, Madrelle J, Barends C, de Graaf C, Parrott H, Morgan S, Weenen H, Hetherington MM. Application and validation of the Feeding Infants: Behaviour and Facial Expression Coding System (FIBFECS) to assess liking and wanting in infants at the time of complementary feeding. Food Quality and Preference. 2016; 48: 228-237.
Barrett KJ, Flesher A, Moding KJ, Johnson SL. Characterizing Caregiver Verbalizations to Infants During the Introduction of a Novel Food. Current Developments in Nutrition. 2021; 5(Supplement_2): 716-716.
Shapiro ALB, Barrett K, Tanner B, Schaefer C, Forestell CA, Diab L, Johnson SL. Children's Introduction to Novel Plant-Based Foods through Varying Repeated Exposure Schedules. J Pediatr. 2026 Jul;294:115082. doi: 10.1016/j.jpeds.2026.115082. Epub 2026 Mar 26.
PubMed 41903739
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Starts: Pacing of Children's Introduction to New Plant-Based Foods
- ClinicalTrials.gov ID
- NCT05639361
- Acronym / sponsor ID
- 22-1618
- Conditions
- Feeding Behavior
- Keywords
- Repeated Exposure, Infant/Toddler Feeding, Eating Behaviors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Temple University, Vitamix Foundation
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Decades of research have established that providing repeated exposure to new foods is the most robust strategy for promoting children's acceptance of new foods (1). However, there is little guidance on how best to translate this recommendation into everyday family life about how often to introduce children to new foods. We propose to conduct a proof-of-concept randomized trial that will evaluate three different schedules of repeated exposure to a novel vegetable, which will help to identify the optimal "pacing" of repeated exposure to promote children's acceptance (i.e., intake) of new vegetables. Here we define "pacing" as how often (every day, every few days, etc.) and across what interval of time (days, weeks, months) repeated exposure is effective for infants to learn to accept a novel food.
Detailed description
Child acceptance of a novel vegetable will be assessed at 4 periodic consumption tests. Participants will visit the Children's Eating Laboratory where caregivers will offer their infants the novel vegetable in the format of their choice (pureed, mashed, or cut into small pieces). These visits will occur at: 1) baseline; 2) 2 weeks to obtain an interim measure of acceptance; 3) 6 weeks to measure acceptance at the end of the exposure period, and 4) 3 months (approximately 6 weeks from the end of the exposure period) to measure longer-term acceptance. Caregivers will be asked not to feed their child less than 90 minutes before arriving for their visit, so that their child will be hungry when they are being offered food. The feeding sessions during each visit will be video recorded. Child acceptance of the novel vegetable will be measured by intake (consumption in grams) and rate of acceptance. The vegetable will be weighed before and after it is offered to calculate intake by the child. The videos will be coded by trained coders trained to reliability, who will code for the child's rate of acceptance of the novel food, which ranges from rejection of the food to eager anticipation of the bite (Hetherington et al. 2016 Food Qual Prefer; Nekitsing et al. 2016 Food Qual Prefer), and for child and caregiver behaviors (Barrett et al. 2021 Curr Dev Nutr).
Caregivers will be provided the novel vegetable to offer their child at home. They will be asked to offer a small taste (2 small bites' worth or up to 3 rejections) at the intervals specified above. During the in-home exposure period, caregivers will be asked to keep a brief log of each offer of the novel food. These logs will include the method of food preparation (pureed or mashed vs. whole or in small pieces), whether the caregiver fed the child or the child fed themselves, whether the child tasted the food, and the caregiver's perception of the child's liking of the vegetable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Condensed | – | Behavioral: Repeated ExposureWill complete a "traditional" schedule of 10 exposures over a 2-week period followed by a one-month "break" period before the final assessment. Because this schedule of exposure has been used most frequently in repeated exposure studies, this group will serve as the reference group. |
| Periodic | – | Behavioral: Repeated ExposureWill complete a schedule of 5 exposures over a 2-week period, followed by a 2-week break, and then another 5 exposures over an additional 2-week period. |
| Extended | – | Behavioral: Repeated ExposureWill complete a schedule of 10 exposures over a continuous 6-week period of time (approximately one exposure every 3-5 days). |
Who may qualify
- Ages
- 9 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population includes healthy, typically-developing infants aged 9-12 months and a healthy primary caregiver living in the Denver, CO metro area.
Key inclusion criteria (4 listed)
- Adult caregivers ≥ 18 years of age
- Infants 9-12 months of age
- Infants born ≥ 37 weeks gestational age
- Infants have not been diagnosed with developmental delays, congenital or other medical conditions that may interfere with feeding (e.g., dysphagia).
Key exclusion criteria (5 listed)
- Caregivers younger than 18 years of age
- Caregivers do not speak English or Spanish
- Caregivers do not live in the Denver Metro area
- Infants who were born < 37 weeks gestational age
- Infants have been diagnosed with a developmental delay or congenital or medical condition that may interfere with feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repeated ExposureCaregivers will be asked to offer a novel vegetable to their infant/toddler 10 times at home according to the schedule of repeated exposure to which they are randomized. | Behavioural | Extended, Periodic, Standard Condensed |
Primary outcome
Change in Consumption of the Novel Vegetable (Intervention Midpoint)
Time frame: Baseline, Follow-up 1
Change in the amount of novel food consumed (in g)
Change in Consumption of the Novel Vegetable (Intervention Endpoint)
Time frame: Baseline, Follow-up 2
Change in the amount of novel food consumed (in g)
Change in Consumption of the Novel Vegetable (Post-Intervention)
Time frame: Baseline, Follow-up 3
Change in the amount of novel food consumed (in g)
Change in Rate of Acceptance of the Novel Vegetable (Intervention Midpoint)
Time frame: Baseline, Follow-up 1
Difference in mean rate of acceptance between between follow-up and baseline. 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)
Change in Rate of Acceptance of the Novel Vegetable (Intervention Endpoint)
Time frame: Baseline, Follow-up 2
Difference in mean rate of acceptance between between end of intervention and baseline. 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)
Change in Rate of Acceptance of the Novel Vegetable (Post-Intervention)
Time frame: Baseline, Follow-up 3
Difference in mean rate of acceptance between between post-intervention follow-up and baseline. 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- BackgroundHetherington MM, Madrelle J, Nekitsing C, Barends C, de Graaf C, Morgan S, Parrott H, Weenen H. Developing a novel tool to assess liking and wanting in infants at the time of complementary feeding - The Feeding Infants: Behaviour and Facial Expression Coding System (FIBFECS). Food Quality and Preference. 2016; 48: 238-250.
- BackgroundNekitsing C, Madrelle J, Barends C, de Graaf C, Parrott H, Morgan S, Weenen H, Hetherington MM. Application and validation of the Feeding Infants: Behaviour and Facial Expression Coding System (FIBFECS) to assess liking and wanting in infants at the time of complementary feeding. Food Quality and Preference. 2016; 48: 228-237.
- BackgroundBarrett KJ, Flesher A, Moding KJ, Johnson SL. Characterizing Caregiver Verbalizations to Infants During the Introduction of a Novel Food. Current Developments in Nutrition. 2021; 5(Supplement_2): 716-716.
- Derived from this study: PubMed 41903739Shapiro ALB, Barrett K, Tanner B, Schaefer C, Forestell CA, Diab L, Johnson SL. Children's Introduction to Novel Plant-Based Foods through Varying Repeated Exposure Schedules. J Pediatr. 2026 Jul;294:115082. doi: 10.1016/j.jpeds.2026.115082. Epub 2026 Mar 26.
- Individual participant dataSharing planned: Undecided. Data may be available upon request to the Principal Investigator
Related trials for Feeding Behavior
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
RecruitingObservational study
Children s Growth and Behavior Study
Obesity, Eating Behaviors
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine J Barrett, PhD principal investigator
University of Colorado, Denver
Susan L Johnson, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Feeding Behavior, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katherine J Barrett, PhD (3037244710, katherine.barrett@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Consumption of the Novel Vegetable (Intervention Midpoint) (time frame: Baseline, Follow-up 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05639361, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.