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

NCT03138551 | Completed DMC

• 1 other identifier: PRO15060533
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Feeding Disorder of Infancy or Early Childhood

Keywords

Sensory Food Aversions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 3-Day Food Diary

  Baseline through Study Completion (1 month)

• Behavioral Pediatric Feeding Assessment (BPFAS)

  Baseline through Study Completion (1 month)

Study Arms (1)

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 Therapist support withdrawn.

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

Interventions

Mealtime PREP (Promoting Routines of Exploration and Play) BEHAVIORAL

Mealtime PREP

Eligibility Criteria

• Age: 18 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (1)

• Caldwell AR, Skidmore ER, Raina KD, Rogers JC, Terhorst L, Danford CA, Bendixen RM. Behavioral Activation Approach to Parent Training: Feasibility of Promoting Routines of Exploration and Play During Mealtime (Mealtime PREP). Am J Occup Ther. 2018 Nov/Dec;72(6):7206205030p1-7206205030p8. doi: 10.5014/ajot.2018.028365.

  PMID: 30760395 DERIVED

Study Officials

• Angela R Caldwell, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single-Case Experimental Design

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 3, 2017
• Study Start: October 11, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)