Skip to main content
OpenTrials
Completed

NCT Number: NCT03138551

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

About this study

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parent-training (while parents are practicing skills learned), and following parent training (when therapist support is withdrawn).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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child must meet all criteria of the diagnosis of Sensory Food Aversions
  • The child consistently refuses to eat specific foods with specific tastes/textures and/or smells.
  • 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).
  • The child eats without difficulty when offered preferred foods.
  • 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

Treatment and study plan

Mealtime PREP (Promoting Routines of Exploration and Play)

Behavioral

Primary outcomes

  1. Food Acceptance

    Time frame: 30 meals video recorded throughout study participation (10 per phase, 1 month)

    Significant change in percentage of targeted food accepted between phases.

Secondary outcomes

  1. 3-Day Food Diary

    Time frame: Baseline through Study Completion (1 month)

    Increased number of foods eaten over a three-day period.

  2. Behavioral Pediatric Feeding Assessment (BPFAS)

    Time frame: Baseline through Study Completion (1 month)

    Clinically relevant change in child feeding behavior and/or parental report of mealtime problems.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 3, 2017
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.