- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03324568
Helping Young Children Improve Eating
February 22, 2019 updated by: Kelly Tanner
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
156
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Educational handout
|
Participants will receive educational handouts describing behavioral techniques to improve parent and child eating behavior.
|
EXPERIMENTAL: Video plus educational handout
|
Participants will receive educational handouts describing behavioral techniques to improve parent and child eating behavior.
Participants will receive educational videos describing behavioral techniques to improve parent and child eating behavior.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 4, 2018
Primary Completion (ACTUAL)
January 8, 2019
Study Completion (ACTUAL)
January 8, 2019
Study Registration Dates
First Submitted
October 17, 2017
First Submitted That Met QC Criteria
October 24, 2017
First Posted (ACTUAL)
October 27, 2017
Study Record Updates
Last Update Posted (ACTUAL)
February 25, 2019
Last Update Submitted That Met QC Criteria
February 22, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB17-00420
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Not yet decided.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Feeding and Eating Disorders of Childhood
-
Children's Mercy Hospital Kansas CityThe Gerber FoundationEnrolling by invitationFeeding and Eating Disorders of Childhood | Gastrostomy | Feeding Disorder of Infancy and ChildhoodUnited States
-
Meyer Children's Hospital IRCCSActive, not recruitingFeeding and Eating Disorders of ChildhoodItaly
-
Benny Kerzner, MDAbbott NutritionWithdrawnFeeding and Eating Disorders of Childhood | Feeding DifficultiesUnited States
-
Emory UniversityCompletedFeeding and Eating Disorders of ChildhoodUnited States
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin; Filiere de Sante Maladies Rares TETECOURecruiting
-
Universidad Francisco de VitoriaDavid Varillas Delgado; María Cristina Martincrespo-Blanco; Saray Blanco-Abril; María Gema Cid-Expósito and other collaboratorsCompleted
-
Federal University of Health Science of Porto AlegreMinistry of Health, Brazil; Fundação de Amparo à Pesquisa do Estado do Rio...CompletedFeeding and Eating Disorders of ChildhoodBrazil
-
Emory UniversityCompletedFeeding and Eating Disorders of ChildhoodUnited States
-
University of BristolMedical Research Council; Wellcome Trust; NestléCompletedFeeding and Eating Disorders of Childhood | Parent-Child Relations | Parenting | Child Behavior | Eating Behavior | Child Rearing
-
BeerYaakov Mental Health CenterUnknownFeeding and Eating Disorders of Childhood | Developmental DisabilitiesIsrael
Clinical Trials on Educational Handout
-
Elizabeth MuellerCompletedPelvic Floor Disorders | Patient ComplianceUnited States
-
Stanford UniversityRecruitingSelf Efficacy | Sleepiness | Lifestyle, Healthy | Work Related Stress | Alertness | Self-Compassion | Shift-Work Related Sleep DisturbanceUnited States
-
University of MichiganCommunity Foundation of Greater FlintRecruitingAnterior Cruciate Ligament Injuries | Lower Extremity ProblemUnited States
-
University of Colorado, DenverNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...CompletedHeart Failure | Heart Failure, SystolicUnited States
-
University of PennsylvaniaCompletedHPV-Related Cervical CarcinomaUnited States
-
Kaiser PermanentePatient-Centered Outcomes Research InstituteRecruitingHypoglycemia | Type 2 Diabetes Treated With Insulin | Primary Health Care | PolypharmacyUnited States
-
Wake Forest University Health SciencesRecruitingStorytelling To Prevent Obesity and Encourage Responsive Feeding Practices in Young Children (STORY)Obesity, ChildhoodUnited States
-
VA Office of Research and DevelopmentCompleted
-
University of California, San DiegoCompleted
-
University of Kansas Medical CenterCompleted