NCT03324568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

February 4, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2019

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

October 17, 2017

Last Update Submit

February 22, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Behavioral Pediatrics Feeding Assessment

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

    4 weeks

Secondary Outcomes (1)

  • Food Frequency Questionnaire

    4 weeks

Study Arms (2)

Educational handout

OTHER
Behavioral: Educational Handout

Video plus educational handout

EXPERIMENTAL
Behavioral: Parent Education VideosBehavioral: Educational Handout

Interventions

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

Video plus educational handout

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

Educational handoutVideo plus educational handout

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders of Childhood

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 27, 2017

Study Start

February 4, 2018

Primary Completion

January 8, 2019

Study Completion

January 8, 2019

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations