- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04075552
Healthy Eating ASD
Improving Healthy Eating of Children With Autism in a School Setting
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.
Study Overview
Status
Conditions
Detailed 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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Fleetwood, Pennsylvania, United States, 19522
- Hogan Learning Academy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participants
Participants are students from a specialized school for children with autism.
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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.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Increased consumption of healthy foods
Time Frame: Through study completion, 1 year.
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Direct measure of the number of healthy foods items eaten
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Through study completion, 1 year.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00005814
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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