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Clinical Trials/NCT03138551
NCT03138551CompletedNot 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 enrollmentStarted: October 11, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Food Acceptance

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(while parents are practicing skills learned), and following parent training (when therapist support is withdrawn).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

Study Design

Study Type
Interventional
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Months to 60 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Mealtime PREP

Experimental

Every participant enrolled in this single-case experimental design trial with multiple replications progressed through three phases.

A: Baseline - typical mealtimes in the home.

B: Parent-Training - parents trained in Mealtime PREP (Promoting Routines of Exploration and Play) intervention.

B-prime: Family Autonomy - parents continue to deliver treatment strategies. Therapist support withdrawn.

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

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

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Angela Caldwell

Assistant Professor

University of Pittsburgh

Study Sites (1)

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