ClinicalTrials.gg
CompletedNCT03324568Updated Feb 25, 2019

Helping Young Children Improve Eating

An interventional study of Parent Education Videos and Educational Handout in Feeding and Eating Disorders of Childhood, sponsored by Kelly Tanner. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-02-25.

Sponsored by Kelly Tanner · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
156
Allocation
Randomized
Sex
All
01

Study 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 promote feeding in young children with feeding difficulties.

02

Conditions studied

  • Feeding and Eating Disorders of Childhood
03

In context

Feeding and Eating Disorders of Childhood

21 studies on the registry are indexed under Feeding and Eating Disorders of Childhood; 3 are open to participants now.

This study's enrollment of 156 is above the median of 85 across 10 interventional studies indexed under Feeding and Eating Disorders of Childhood.

Browse Feeding and Eating Disorders of Childhood studies →

Lead sponsor

Kelly Tanner is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
156 participants (actual)

Study arms

  • Other
    Educational handout

    Behavioral: Educational Handout

  • Experimental
    Video plus educational handout

    Behavioral: Parent Education Videos · Behavioral: Educational Handout

Interventions

  • BehavioralParent Education Videos

    Participants will receive educational videos describing behavioral techniques to improve parent and child eating behavior.

  • BehavioralEducational Handout

    Participants will receive educational handouts describing behavioral techniques to improve parent and child eating behavior.

06

What researchers measure

Primary outcomes

  1. Behavioral Pediatrics Feeding Assessment

    Parent questionnaire that measures parent and child feeding behaviors and attitudes. A higher score indicates more difficulties.

    Time frame: 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.

    Time frame: 4 weeks

07

Study locations

1 site
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
08

References and documents

Individual participant data

Plan to share: Undecided — Not yet decided.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Jan 2019, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 17, 2017
First posted
Oct 27, 2017
StartActual
Feb 4, 2018
Primary completionActual
Jan 8, 2019
CompletionActual
Jan 8, 2019
Last update
Feb 25, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03324568
Lead sponsor
Kelly Tanner
Responsible party
Kelly Tanner (Principal Investigator, Nationwide Children's Hospital) — Sponsor-investigator
First posted
Oct 27, 2017
Start date
Feb 4, 2018
Primary completion
Jan 8, 2019
Completion
Jan 8, 2019
Last update
Feb 25, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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