Food SelectivityNCT04075552
Healthy Eating ASD
A study testing Pre Meal Presentation, Pre Meal Presentation + Modeling and Pre Meal Presentation + Token Economy in people with Food Selectivity, run by Penn State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Selectivity
- What is being tested?
- Pre Meal Presentation, Pre Meal Presentation + Modeling and Pre Meal Presentation + Token Economy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2016to 26 Sep 2022
- Phase
- Interventional
- 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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants will be students in a private school with a diagnosis of an autism spectrum disorder and between 6-14 years of age.
Who cannot join
- Parents who report their children have food allergies of any kind will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hogan Learning Academy
Fleetwood, Pennsylvania, 19522
About this study
Official title: 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.
Read the 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.
- Conditions
- Food Selectivity
- Being tested
- Pre Meal Presentation, Pre Meal Presentation + Modeling, Pre Meal Presentation + Token Economy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre Meal PresentationBehavioural
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 + ModelingBehavioural
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 EconomyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Participants are students from a specialized school for children with autism. Receives: Behavioral: Pre Meal Presentation; Behavioral: Pre Meal Presentation + Modeling; Behavioral: Pre Meal Presentation + Token Economy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased consumption of healthy foods
Direct measure of the number of healthy foods items eaten
Measured: Through study completion, 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start23 Sep 2016
- Primary completion26 Sep 2022
- Study completion26 Sep 2022
Why it stopped: Disruptions due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food SelectivityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single subject research methodology
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Ivy, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075552
- Sponsor's protocol ID
- STUDY00005814
- Status last verified
- Sep 2022
- First submitted
- 28 Aug 2019
- Last updated
- 28 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Healthy Eating of Children With Autism in a School Setting
- ClinicalTrials.gov ID
- NCT04075552
- Acronym / sponsor ID
- STUDY00005814
- Conditions
- Food Selectivity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Disruptions due to COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 23 Sep 2016 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 26 Sep 2022 (actual)
- First posted
- 30 Aug 2019 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single subject research methodology
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Behavioral: Pre Meal Presentation, Behavioral: Pre Meal Presentation + Modeling, Behavioral: Pre Meal Presentation + Token EconomyParticipants are students from a specialized school for children with autism. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants will be students in a private school with a diagnosis of an autism spectrum disorder and between 6-14 years of age.
Key exclusion criteria (1 listed)
- Parents who report their children have food allergies of any kind will be excluded.
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 |
|---|---|---|
| Pre Meal PresentationPre-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. | Behavioural | Participants |
| Pre Meal Presentation + ModelingSimilar 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. | Behavioural | Participants |
| Pre Meal Presentation + Token EconomySimilar 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. | Behavioural | Participants |
Primary outcome
Increased consumption of healthy foods
Time frame: Through study completion, 1 year.
Direct measure of the number of healthy foods items eaten
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
Related trials for Food Selectivity
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Clinical Trial of "Exploradores de Sabores" to Improve Food Selectivity in ASD Kids
Autism Spectrum Disorder, Food Selectivity
Recruiting
Exploring Virtual Reality As an Intervention for Food Selectivity: a Clinical Trial
Autism, Autism Spectrum 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre Meal Presentation, Pre Meal Presentation + Modeling and Pre Meal Presentation + Token Economy in people with Food Selectivity, run by Penn State University 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 28 Sep 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased consumption of healthy foods (time frame: Through study completion, 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2022.