Back to resultsHelping Young Children Improve Eating
Primary Purpose
Feeding and Eating Disorders of Childhood
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent Education Videos
Educational Handout
Sponsored by
About this trial
This is an interventional treatment trial for Feeding and Eating Disorders of Childhood
Eligibility Criteria
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:
- 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.
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Educational handout
Video plus educational handout
Arm Description
Outcomes
Primary Outcome Measures
Behavioral Pediatrics Feeding Assessment
Parent questionnaire that measures parent and child feeding behaviors and attitudes. A higher score indicates more difficulties.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03324568
Brief Title
Helping Young Children Improve Eating
Official Title
Helping Young Children Improve Eating
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 4, 2018 (Actual)
Primary Completion Date
January 8, 2019 (Actual)
Study Completion Date
January 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kelly Tanner
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding and Eating Disorders of Childhood
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Educational handout
Arm Type
Other
Arm Title
Video plus educational handout
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Parent Education Videos
Intervention Description
Participants will receive educational videos describing behavioral techniques to improve parent and child eating behavior.
Intervention Type
Behavioral
Intervention Name(s)
Educational Handout
Intervention Description
Participants will receive educational handouts describing behavioral techniques to improve parent and child eating behavior.
Primary Outcome Measure Information:
Title
Behavioral Pediatrics Feeding Assessment
Description
Parent questionnaire that measures parent and child feeding behaviors and attitudes. A higher score indicates more difficulties.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Food Frequency Questionnaire
Description
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not yet decided.
Learn more about this trial
Helping Young Children Improve Eating
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