Healthy Eating ASD

Food Selectivity Clinical Trial

Official title:

Improving Healthy Eating of Children With Autism in a School Setting

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04075552
• Other study ID #: STUDY00005814
• Status: Withdrawn
• Phase: N/A
• Start date: September 23, 2016
• Est. completion date: September 26, 2022

Study information

• Verified date: September 2022
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Most studies which have addressed food selectivity among children with autism spectrum disorders have been conducted in either clinic or home settings. School-based research has been conducted to increase healthy eating, but this research was largely conducted with children without special needs or if children with special needs did participate, they were not identified.

This study will focus on increasing consumption of fruits and vegetables among children with an Autism Spectrum Disorder in a school setting.

Description:

Food Preference Inventory: A survey of food preference and eating habits, developed by the experimenter, will be provided to the parents/guardians of prospective participants. The Food Preference Inventory is anticipated to take between 10 and 20 mins to complete. The parent/guardian of the prospective participant is asked to return toe inventory to the school if 1) the parent/guardian gives permission for his/her child to participate and 2) if the child does not have a food allergy.

General Procedures: Each day of the study (1-5 days per week), school staff will offer participants a small portion of a fruit or vegetable (about 1/8 cup) to eat during lunch time. The participant will have about 5 min to consume the item before it is recollected by school staff.

Baseline: The fruit or vegetable is presented with the participants lunch. Eating the item produces no programmed consequences.

Single Item Presentation: The fruit or vegetable is presented before the participants lunch (about 5 min). Eating the item produces no programmed consequences.

Single Item Presentation + Modeling: The fruit or vegetable is presented before the participants lunch (about 5 min). School staff will model eating the food item.

Single Item Presentation + Token Economy: The fruit or vegetable is presented before the participants lunch (about 5 min). Eating the item will produce a token (e.g., a sticker or hole punch). Once the student collects a few tokens (e.g., 3-5), he/she can exchange the tokens for a small price (e.g., pencil or crayon).

Data Collection: Data will be collected by school staff. Staff will record whether each participant consume the fruit or vegetable item.

Safety Procedures: School staff will monitor lunch - as they typically do.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 26, 2022
• Est. primary completion date: September 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

Inclusion Criteria:

• Participants will be students in a private school with a diagnosis of an autism spectrum disorder and between 6-14 years of age.

Exclusion Criteria:

• Parents who report their children have food allergies of any kind will be excluded.

Related Conditions & MeSH terms

• Food Selectivity

Intervention

Behavioral:
• Pre Meal Presentation
Pre-Meal Presentation. In the Pre-Meal Presentation (PMP) condition, school staff delivered the plate of vegetable pieces prior to students regularly scheduled lunchtime (about 5 min). Like baseline, no programmed consequences were provided for student interaction or consumption of the vegetables.
• Pre Meal Presentation + Modeling
Similar to the prior condition, each participant will be offered a plate containing target foods for 4 min. Once the plate has been delivered to each participant, a staff person will model eating the food. The model will have an identical plate of food. Within six feet of students oriented towards the model (i.e., the students will be facing the model), the model will pick up one piece of food, say "Yum, this looks good" in a loud and excited tone, eat it, and then deliver a "soft" prompt to the participants to try it (e.g., "You should try this!"). Staff will avoid giving a firm/hard demand (e.g., "Eat the food"). Repeat this for four pieces of food, alternating between the two target foods, with about 10-20 sec between each bite. Repeat the model as necessary based on the room arrangement, such that each students contacts the model within six feet while oriented towards the model.
• Pre Meal Presentation + Token Economy
Similar to prior condition, expect each participant can earn tokens for eating food items. Tokens can be exchanged for small prizes (e.g., pencil or sticker) at the end of a session.

Locations

Country	Name	City	State
United States	Hogan Learning Academy	Fleetwood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased consumption of healthy foods	Direct measure of the number of healthy foods items eaten	Through study completion, 1 year.