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Helping Young Children Improve Eating

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ClinicalTrials.gov Identifier: NCT03324568
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Kelly Tanner, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Feeding and Eating Disorders of Childhood Behavioral: Parent Education Videos Behavioral: Educational Handout Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Helping Young Children Improve Eating
Actual Study Start Date : February 4, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Educational handout Behavioral: Educational Handout
Participants will receive educational handouts describing behavioral techniques to improve parent and child eating behavior.

Experimental: Video plus educational handout Behavioral: Parent Education Videos
Participants will receive educational videos describing behavioral techniques to improve parent and child eating behavior.

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Food Frequency Questionnaire [ Time Frame: 4 weeks ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324568


Contacts
Contact: Kelly Tanner, PhD 6147228697 kelly.tanner@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Kelly Tanner, PhD    614-722-8697    kelly.tanner@nationwidechildrens.org   
Sponsors and Collaborators
Kelly Tanner

Responsible Party: Kelly Tanner, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03324568     History of Changes
Other Study ID Numbers: IRB17-00420
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not yet decided.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Feeding and Eating Disorders
Feeding and Eating Disorders of Childhood
Mental Disorders