Feeding and Eating Disorders of ChildhoodNCT03324568
Helping Young Children Improve Eating
A study testing Parent Education Videos and Educational Handout in people with Feeding and Eating Disorders of Childhood, run by Kelly Tanner at 1 site in United States.
Trial summary
This study will evaluate the impact of different types of educational materials on parent and child feeding behaviors. Specifically, the investigators will test the feasibility, acceptability, and effectiveness of an investigator-developed series of parent training videos designed to teach behavioral strategies to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Feeding and Eating Disorders of Childhood
- What is being tested?
- Parent Education Videos and Educational Handout
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2018to 8 Jan 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parents of patients ages 18 months through 6 years currently on the waitlist (for an estimated time of at least 4-6 weeks) for outpatient feeding therapy, or with feeding concerns identified in a primary care visit; English-speaking parents; parent has the technology to access the videos and REDCap survey.
Who cannot join
- Parents of patients not currently eating by mouth; parents of patients currently being treated by a psychologist, occupational therapist, or speech therapist to address feeding, eating, or swallowing skills; parents of patients who have aspirated on their most recent videofluoroscopic swallow study or who currently have a tracheostomy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This study will evaluate the impact of different types of educational materials on parent and child feeding behaviors. Specifically, the investigators will test the feasibility, acceptability, and effectiveness of an investigator-developed series of parent training videos designed to teach behavioral strategies to promote feeding in young children with feeding difficulties.
- Being tested
- Parent Education Videos, Educational Handout
- Medical subject headings
- Feeding and Eating Disorders of Childhood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Education VideosBehavioural
Participants will receive educational videos describing behavioral techniques to improve parent and child eating behavior.
Educational HandoutBehavioural
Participants will receive educational handouts describing behavioral techniques to improve parent and child eating behavior.
| Study group | Role | What they receive |
|---|---|---|
| Educational handout | Other | Not described Receives: Behavioral: Educational Handout |
| Video plus educational handout | Experimental | Not described Receives: Behavioral: Parent Education Videos; Behavioral: Educational Handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Pediatrics Feeding Assessment
Parent questionnaire that measures parent and child feeding behaviors and attitudes. A higher score indicates more difficulties.
Measured: 4 weeks
Secondary outcomes (1)
Food Frequency Questionnaire
Parent questionnaire that measures the amount of different foods children ate over a specific time period (e.g. one month). A higher score indicates more different foods were consumed by the child.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start4 Feb 2018
- Primary completion8 Jan 2019
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding and Eating Disorders of ChildhoodStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kelly Tanner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kelly Tanner, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324568
- Sponsor's protocol ID
- IRB17-00420
- Status last verified
- Feb 2019
- First submitted
- 17 Oct 2017
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet decided.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Young Children Improve Eating
- ClinicalTrials.gov ID
- NCT03324568
- Acronym / sponsor ID
- IRB17-00420
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Kelly TannerUniversity, hospital or other
- Study start
- 4 Feb 2018 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 27 Oct 2017 (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 study will evaluate the impact of different types of educational materials on parent and child feeding behaviors. Specifically, the investigators will test the feasibility, acceptability, and effectiveness of an investigator-developed series of parent training videos designed to teach behavioral strategies to promote feeding in young children with feeding difficulties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational handout | Other | Behavioral: Educational Handout |
| Video plus educational handout | Experimental | Behavioral: Parent Education Videos, Behavioral: Educational Handout |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parents of patients ages 18 months through 6 years currently on the waitlist (for an estimated time of at least 4-6 weeks) for outpatient feeding therapy, or with feeding concerns identified in a primary care visit; English-speaking parents; parent has the technology to access the videos and REDCap survey.
Key exclusion criteria (1 listed)
- Parents of patients not currently eating by mouth; parents of patients currently being treated by a psychologist, occupational therapist, or speech therapist to address feeding, eating, or swallowing skills; parents of patients who have aspirated on their most recent videofluoroscopic swallow study or who currently have a tracheostomy.
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 |
|---|---|---|
| Parent Education VideosParticipants will receive educational videos describing behavioral techniques to improve parent and child eating behavior. | Behavioural | Video plus educational handout |
| Educational HandoutParticipants will receive educational handouts describing behavioral techniques to improve parent and child eating behavior. | Behavioural | Educational handout, Video plus educational handout |
Primary outcome
Behavioral Pediatrics Feeding Assessment
Time frame: 4 weeks
Parent questionnaire that measures parent and child feeding behaviors and attitudes. A higher score indicates more difficulties.
1 secondary outcome
Food Frequency Questionnaire
Time frame: 4 weeks
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 25 Feb 2019.
- Individual participant dataSharing planned: Undecided. Not yet decided.
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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 Parent Education Videos and Educational Handout in people with Feeding and Eating Disorders of Childhood, run by Kelly Tanner 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: finished, as of the sponsor's last update on 25 Feb 2019. 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 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?
Behavioral Pediatrics Feeding Assessment (time frame: 4 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 25 Feb 2019; AzTrials last refreshed its copy on 29 Oct 2026.