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Clinical Trials/NCT03138551
NCT03138551
Completed
Not Applicable

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

University of Pittsburgh1 site in 1 country20 target enrollmentOctober 11, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Feeding Disorder of Infancy or Early Childhood
Sponsor
University of Pittsburgh
Enrollment
20
Locations
1
Primary Endpoint
Food Acceptance
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

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(while parents are practicing skills learned), and following parent training (when therapist support is withdrawn).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

Registry
clinicaltrials.gov
Start Date
October 11, 2015
End Date
October 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Angela Caldwell

Assistant Professor

University of Pittsburgh

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

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

  • Behavioral Pediatric Feeding Assessment (BPFAS)(Baseline through Study Completion (1 month))
  • 3-Day Food Diary(Baseline through Study Completion (1 month))

Study Sites (1)

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