Healthy Starts: Repeated Exposure Pilot

NCT05639361 | Unknown

• 1 other identifier: 22-1618
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Feeding Behavior

Keywords

Repeated Exposure; Infant/Toddler Feeding; Eating Behaviors

Outcome Measures

Primary Outcomes (6)

• Change in Consumption of the Novel Vegetable (Intervention Midpoint)

  Change in the amount of novel food consumed (in g)

  Baseline, Follow-up 1

• Change in Consumption of the Novel Vegetable (Intervention Endpoint)

  Change in the amount of novel food consumed (in g)

  Baseline, Follow-up 2

• Change in Consumption of the Novel Vegetable (Post-Intervention)

  Change in the amount of novel food consumed (in g)

  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)

  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)

  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)

  Baseline, Follow-up 3

Study Arms (3)

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.

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.

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).

Behavioral: Repeated Exposure

Interventions

Repeated Exposure 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; Periodic; Standard Condensed

Eligibility Criteria

• Age: 9 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Temple University: collaborator
• Vitamix Foundation: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (3)

• 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.

  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.

  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.

  BACKGROUND

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Katherine J Barrett, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Susan L Johnson, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine J Barrett, PhD

CONTACT

3037244710; katherine.barrett@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 6, 2022
• Study Start: April 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

US (1)