Feeding Disorder of Infancy or Early ChildhoodNCT03138551
Examining Relationships Between Family Mealtime and Feeding Outcomes in Young Children With Sensory Food Aversions
A study testing Mealtime PREP (Promoting Routines of Exploration and Play) in people with Feeding Disorder of Infancy or Early Childhood, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 months
- Conditions the study is for
- Feeding Disorder of Infancy or Early Childhood
- What is being tested?
- Mealtime PREP (Promoting Routines of Exploration and Play)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2015to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Examining Relationships Between Family Mealtime Routines 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.
Read the 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.
- Being tested
- Mealtime PREP (Promoting Routines of Exploration and Play)
- Keywords
- Sensory Food Aversions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mealtime PREP (Promoting Routines of Exploration and Play)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mealtime PREP (Promoting Routines of Exploration and Play) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Acceptance
Significant change in percentage of targeted food accepted between phases.
Measured: 30 meals video recorded throughout study participation (10 per phase, 1 month)
Secondary outcomes (2)
3-Day Food Diary
Increased number of foods eaten over a three-day period.
Measured: Baseline through Study Completion (1 month)
Behavioral Pediatric Feeding Assessment (BPFAS)
Clinically relevant change in child feeding behavior and/or parental report of mealtime problems.
Measured: Baseline through Study Completion (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start11 Oct 2015
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feeding Disorder of Infancy or Early ChildhoodStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Model description
- Single-Case Experimental Design
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Caldwell, University of Pittsburgh
- Investigators
- Angela R Caldwell, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138551
- Sponsor's protocol ID
- PRO15060533
- Status last verified
- Feb 2019
- First submitted
- 28 Apr 2017
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: There is currently no plan to make individual participant data available to other researchers.
Publications
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.
PubMed 30760395
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Relationships Between Family Mealtime Routines and Feeding Outcomes in Young Children With Sensory Food Aversions
- ClinicalTrials.gov ID
- NCT03138551
- Acronym / sponsor ID
- PRO15060533
- Keywords
- Sensory Food Aversions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 11 Oct 2015 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-Case Experimental Design
| Arm | Type | Receives |
|---|---|---|
| Mealtime PREP | Experimental | Behavioral: Mealtime PREP (Promoting Routines of Exploration and Play)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. |
Who may qualify
- Ages
- 18 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child must meet all criteria of the diagnosis of Sensory Food Aversions
- Parent is able to read, write, speak and understand English.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mealtime PREP (Promoting Routines of Exploration and Play) | Behavioural | Mealtime PREP |
Primary outcome
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.
2 secondary outcomes
3-Day Food Diary
Time frame: Baseline through Study Completion (1 month)
Behavioral Pediatric Feeding Assessment (BPFAS)
Time frame: Baseline through Study Completion (1 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Derived from this study: PubMed 30760395Caldwell 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.
- Individual participant dataSharing planned: No. There is currently no plan to make individual participant data available to other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela R Caldwell, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mealtime PREP (Promoting Routines of Exploration and Play) in people with Feeding Disorder of Infancy or Early Childhood, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Acceptance (time frame: 30 meals video recorded throughout study participation (10 per phase, 1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03138551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.