Healthy Eating ASD

September 26, 2022 updated by: Jonathan Ivy, Penn State University

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Fleetwood, Pennsylvania, United States, 19522
        • Hogan Learning Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Participants
Participants are students from a specialized school for children with autism.
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.
Behavioral: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Increased consumption of healthy foods
Time Frame: Through study completion, 1 year.
Direct measure of the number of healthy foods items eaten
Through study completion, 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00005814

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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