Back to resultsExamining Relationships Between Family Mealtime and Feeding Outcomes in Young Children With Sensory Food Aversions
Primary Purpose
Feeding Disorder of Infancy or Early Childhood
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mealtime PREP (Promoting Routines of Exploration and Play)
Sponsored by
About this trial
This is an interventional treatment trial for Feeding Disorder of Infancy or Early Childhood focused on measuring Sensory Food Aversions
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: None
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mealtime PREP
Arm Description
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 Therapist support withdrawn.
Outcomes
Primary Outcome Measures
Food Acceptance
Significant change in percentage of targeted food accepted between phases.
Secondary Outcome Measures
3-Day Food Diary
Increased number of foods eaten over a three-day period.
Behavioral Pediatric Feeding Assessment (BPFAS)
Clinically relevant change in child feeding behavior and/or parental report of mealtime problems.
Full Information
NCT ID
NCT03138551
First Posted
April 28, 2017
Last Updated
February 5, 2019
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT03138551
Brief Title
Examining Relationships Between Family Mealtime and Feeding Outcomes in Young Children With Sensory Food Aversions
Official Title
Examining Relationships Between Family Mealtime Routines and Feeding Outcomes in Young Children With Sensory Food Aversions
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 11, 2015 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Disorder of Infancy or Early Childhood
Keywords
Sensory Food Aversions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Single-Case Experimental Design
Masking
None (Open Label)
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mealtime PREP
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Mealtime PREP (Promoting Routines of Exploration and Play)
Primary Outcome Measure Information:
Title
Food Acceptance
Description
Significant change in percentage of targeted food accepted between phases.
Time Frame
30 meals video recorded throughout study participation (10 per phase, 1 month)
Secondary Outcome Measure Information:
Title
3-Day Food Diary
Description
Increased number of foods eaten over a three-day period.
Time Frame
Baseline through Study Completion (1 month)
Title
Behavioral Pediatric Feeding Assessment (BPFAS)
Description
Clinically relevant change in child feeding behavior and/or parental report of mealtime problems.
Time Frame
Baseline through Study Completion (1 month)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
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: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela R Caldwell, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is currently no plan to make individual participant data available to other researchers.
Citations:
PubMed Identifier
30760395
Citation
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.
Results Reference
derived
Learn more about this trial
Examining Relationships Between Family Mealtime and Feeding Outcomes in Young Children With Sensory Food Aversions
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