Healthy Starts: Repeated Exposure Pilot

NCT ID: NCT05639361

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-06-30

Brief 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 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.

Conditions

Feeding Behavior

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Repeated Exposure

Intervention Type: BEHAVIORAL

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.

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.

Repeated Exposure

Intervention Type: BEHAVIORAL

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.

Extended

Will complete a schedule of 10 exposures over a continuous 6-week period of time (approximately one exposure every 3-5 days).

Repeated Exposure

Intervention Type: BEHAVIORAL

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.

Interventions

Repeated Exposure

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Temple University

OTHER

Sponsor Role: collaborator

Vitamix Foundation

UNKNOWN

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine J Barrett, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Susan L Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Katherine J Barrett, PhD

Role: CONTACT

katherine.barrett@cuanschutz.edu

3037244710

Facility Contacts

Katherine J Barrett, PhD

Role: primary

katherine.barrett@cuanschutz.edu

303-724-2922

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

Other Identifiers

22-1618

Identifier Type: -

Identifier Source: org_study_id