Examining Relationships Between Family Mealtime and Feeding Outcomes in Young Children With Sensory Food Aversions

Feeding Disorder of Infancy or Early Childhood Clinical Trial

Official title:

Examining Relationships Between Family Mealtime Routines and Feeding Outcomes in Young Children With Sensory Food Aversions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138551
• Other study ID #: PRO15060533
• Status: Completed
• Phase: N/A
• Start date: October 11, 2015
• Est. completion date: October 1, 2018

Study information

• Verified date: February 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will examine the feasibility and preliminary effects of the Mealtime PREP (Promoting Routines of Exploration and Play) intervention package for young children with Sensory Food Aversions and their parents.

Description:

This pilot study will collect rich data from twenty participants on the feasibility and effects of a novel intervention, the Mealtime PREP, which has a dyadic focus on both the young child and the parent participants. The investigators will collect video recorded child meals in the home during a baseline period (under normal circumstances), during parent-training (while parents are practicing skills learned), and following parent training (when therapist support is withdrawn). This in depth examination of child meals will provide valuable information to guide the optimization of this intervention approach for future trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 60 Months

Eligibility

Inclusion Criteria:

• Child must meet all criteria of the diagnosis of Sensory Food Aversions

1. The child consistently refuses to eat specific foods with specific tastes/textures and/or smells.

2. Onset of food refusal occurs during the introduction of a novel type of food (e.g., the child may drink one type of milk but refuse another, may eat carrots but refuse green beans, may drink milk but refuse baby food).

3. The child eats without difficulty when offered preferred foods.

4. The food refusal causes specific nutritional deficiencies or delay of oral motor development.

• Parent is able to read, write, speak and understand English.

Exclusion Criteria: None

Related Conditions & MeSH terms

• Feeding and Eating Disorders
• Feeding Disorder of Infancy or Early Childhood

Intervention

Behavioral:
• Mealtime PREP (Promoting Routines of Exploration and Play)

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food Acceptance	Significant change in percentage of targeted food accepted between phases.	30 meals video recorded throughout study participation (10 per phase, 1 month)
Secondary	3-Day Food Diary	Increased number of foods eaten over a three-day period.	Baseline through Study Completion (1 month)
Secondary	Behavioral Pediatric Feeding Assessment (BPFAS)	Clinically relevant change in child feeding behavior and/or parental report of mealtime problems.	Baseline through Study Completion (1 month)