Food SelectivityNCT03756844
Effectiveness of the Just Right Challenge Food Club for Decreasing Food Selectivity and Increasing Mealtime Quality
A study testing Just Right Challenge Food Club in people with Food Selectivity, run by Western Michigan University.
Trial summary
This single subject study tested the effectiveness of the Just Right Challenge Food Club for decreasing food selectivity and increasing mealtime qualify for children with developmental disabilities. Read more about this study
- Who is it for?
- Ages 2 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Selectivity
- What is being tested?
- Just Right Challenge Food Club
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- 19 Oct 2016to 12 Dec 2017
- 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 2 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who accepted less than 15 foods as part of their regular diet
- Children who refused whole food groups
Who cannot join
- Children with life threatening food selectivity per parent report and physician referral information
About this study
This single subject study tested the effectiveness of the Just Right Challenge Food Club for decreasing food selectivity and increasing mealtime qualify for children with developmental disabilities.
Read the detailed description
This study used a single subject design to test the effectiveness of the Just Right Challenge Food Club for decreasing food selectivity and increasing mealtime quality for children with developmental disabilities. Baseline data was collected during the time that participants spent on the wait list for treatment. Treatment data was collected each week during treatment session. This protocol produced a significant change in both the number of foods the children in the study ate as well as the parents perception of mealtime quality.
- Conditions
- Food Selectivity
- Being tested
- Just Right Challenge Food Club
- Keywords
- Avoidant Restrictive Food Intake Disorder
- Medical subject headings
- Avoidant Restrictive Food Intake Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Just Right Challenge Food ClubBehavioural
Systematic desensitization, positive reinforcement and escape extinction at a level of just right challenge.
| Study group | Role | What they receive |
|---|---|---|
| Just Right Challenge Food Club Protocol | Experimental | There was only one arm in this study. All participants received the Just Right Challenge Food Club Protocol and single subject (time series) data was collected. Receives: Behavioral: Just Right Challenge Food Club |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Food Inventory questionnaire
Parents marked the foods that their child ate over the past week every week for up to 45 weeks
Measured: Every week for up to 45 weeks
Secondary outcomes (1)
Change in About Your Child's Eating questionnaire
A measure of parent perception of mealtime qualify
Measured: Up to 45 weeks between pre and post test measures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start19 Oct 2016
- Primary completion12 Dec 2017
- Study completion12 Dec 2017
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
- This was a single-subject (time series design).
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Michigan University
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Responsible party
- Principal investigator, Michelle A Suarez, Western Michigan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756844
- Sponsor's protocol ID
- JRCFC Single-Subject
- Status last verified
- Nov 2018
- First submitted
- 12 Nov 2018
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Just Right Challenge Food Club for Decreasing Food Selectivity and Increasing Mealtime Quality
- ClinicalTrials.gov ID
- NCT03756844
- Acronym / sponsor ID
- JRCFC Single-Subject
- Conditions
- Food Selectivity
- Keywords
- Avoidant Restrictive Food Intake Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Western Michigan UniversityUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield of Michigan Foundation
- Study start
- 19 Oct 2016 (actual)
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 12 Dec 2017 (actual)
- First posted
- 28 Nov 2018 (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.
This single subject study tested the effectiveness of the Just Right Challenge Food Club for decreasing food selectivity and increasing mealtime qualify for children with developmental disabilities.
Detailed description
This study used a single subject design to test the effectiveness of the Just Right Challenge Food Club for decreasing food selectivity and increasing mealtime quality for children with developmental disabilities. Baseline data was collected during the time that participants spent on the wait list for treatment. Treatment data was collected each week during treatment session. This protocol produced a significant change in both the number of foods the children in the study ate as well as the parents perception of mealtime quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This was a single-subject (time series design).
| Arm | Type | Receives |
|---|---|---|
| Just Right Challenge Food Club Protocol | Experimental | Behavioral: Just Right Challenge Food ClubThere was only one arm in this study. All participants received the Just Right Challenge Food Club Protocol and single subject (time series) data was collected. |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children who accepted less than 15 foods as part of their regular diet
- Children who refused whole food groups
Key exclusion criteria (1 listed)
- Children with life threatening food selectivity per parent report and physician referral information
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 |
|---|---|---|
| Just Right Challenge Food ClubSystematic desensitization, positive reinforcement and escape extinction at a level of just right challenge. | Behavioural | Just Right Challenge Food Club Protocol |
Primary outcome
Change in Food Inventory questionnaire
Time frame: Every week for up to 45 weeks
Parents marked the foods that their child ate over the past week every week for up to 45 weeks
1 secondary outcome
Change in About Your Child's Eating questionnaire
Time frame: Up to 45 weeks between pre and post test measures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Food Selectivity
Recruiting
Clinical Trial of "Exploradores de Sabores" to Improve Food Selectivity in ASD Kids
Autism Spectrum Disorder, Food Selectivity
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.
Questions about this trial
What is this clinical trial studying?
A study testing Just Right Challenge Food Club in people with Food Selectivity, run by Western Michigan University.
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 2 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: finished, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Food Inventory questionnaire (time frame: Every week for up to 45 weeks). 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 30 Nov 2018.