- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03756844
Effectiveness of the Just Right Challenge Food Club for Decreasing Food Selectivity and Increasing Mealtime Quality
November 28, 2018 updated by: Michelle A Suarez, Western Michigan University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
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
Ages Eligible for Study
2 years to 15 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children who accepted less than 15 foods as part of their regular diet
- Children who refused whole food groups
Exclusion Criteria:
- Children with life threatening food selectivity per parent report and physician referral information
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Just Right Challenge Food Club Protocol
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.
|
Systematic desensitization, positive reinforcement and escape extinction at a level of just right challenge.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Every week for up to 45 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in About Your Child's Eating questionnaire
Time Frame: Up to 45 weeks between pre and post test measures.
|
A measure of parent perception of mealtime qualify
|
Up to 45 weeks between pre and post test measures.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
October 19, 2016
Primary Completion (ACTUAL)
December 12, 2017
Study Completion (ACTUAL)
December 12, 2017
Study Registration Dates
First Submitted
November 12, 2018
First Submitted That Met QC Criteria
November 26, 2018
First Posted (ACTUAL)
November 28, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 30, 2018
Last Update Submitted That Met QC Criteria
November 28, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- JRCFC Single-Subject
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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