NCT06266507

Brief Summary

Feeding problems are common in children with a history of premature birth, and these problems continue into early childhood. Feeding problems are affected by many biopsychosocial factors, and the context in which feeding takes place and the attitudes and behaviors of parents can also be effective in the emergence or continuation of these problems. The aim of our study is to evaluate the effects of occupational therapy-based parent coaching intervention on mothers and their children, who are considered to be primarily responsible for the feeding of children in our country. 46 mothers with premature children will be included in our study and participants will be randomly assigned to intervention/control groups. Mothers will fill out a sociodemographic information form, Canadian Occupational Therapy Measure (COPM), Behavioral Pediatric Feeding Assessment Scale, Sensory Profile Questionnaire - Oral Sensory Processing Subtest, Family Feeding Strategies Scale and Parental Self-Efficacy Scale via Google forms. Mothers in the research group will be given online occupational therapy-based parent coaching training for 10 weeks. Second evaluations will be carried out after the training; Final evaluations will be applied after 1 month of follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

July 29, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

January 21, 2026

Status Verified

June 1, 2025

Enrollment Period

11 months

First QC Date

February 6, 2024

Last Update Submit

January 18, 2026

Conditions

Keywords

prematurityfeeding problemsoccupational therapyparent coaching

Outcome Measures

Primary Outcomes (3)

  • Behavioral Pediatric Feeding Assessment Scale

    This scale will be used to evaluate children's nutritional problems. Behavioral Pediatrics Feeding Assessment Scale (BPFAS) was developed by Crist and Napier Philips in 2001 and its original version consists of 35 questions. The usage age range of the survey is between 9 months and 7 years, and it is the scale with the most comprehensive reliability and validity data among the nutrition surveys administered by parents for preschool children. The questionnaire has good test-retest reliability and internal consistency, acceptable-to-good sensitivity, and good-to-excellent specificity. The BPFAS is capable of screening for a broad spectrum of feeding difficulties (nutritional and textural selectivity, food refusal, and oral motor difficulties). Turkish validity study by Önal et al. It was made by in 2017.

    The scale will be applied 3 times in total: at the beginning of the study, 10 weeks after the first evaluation and 4 weeks after the second evaluation.

  • Sensory Profile Questionnaire - Oral Sensory Processing Test

    This scale will be used to examine how children's oral sensory processing skills change before and after the intervention. Ergotherapist Prof. Sensory Profile of the individual developed by Winnie Dunn; It is a measurement tool used to evaluate sensory modulation, in other words, the tendency to respond to sensory stimuli during daily activities and which sensory systems affect daily life more. It is used in children between the ages of 3-10. The individual; The test, which is used to measure functional performance in daily living activities, sensory processing abilities and sensory processing effects, consists of 3 main sub-parameters (sensory processing, modulation and behavioral-emotional responses) and 9 factor scores consisting of these parameters. \*In our study, it was decided to use only the oral sensory processing subtest of questionnaire.

    The scale will be applied 3 times in total: at the beginning of the study, 10 weeks after the first evaluation and 4 weeks after the second evaluation.

  • Canadian Occupational Therapy Measurement (COPM)

    The Canadian Occupational Performance Measurement (COPM) is an outcome measure designed to identify changes in individuals' perceived performance and satisfaction levels over time in the areas of self-care, productivity, and leisure. In the application of the COPM, the client is first interviewed and listed occupations they want to do, are expected to do, but are unable to do, or are dissatisfied with the way they are performed. Performance and satisfaction levels are recorded before and after the intervention, allowing the difference between the two assessments to be calculated. The COPM will be used in this study to determine participants' goals for the intervention and to examine changes in performance and satisfaction following the intervention for the identified occupations.

    The scale will be applied 3 times in total: at the beginning of the study, 10 weeks after the first evaluation and 4 weeks after the second evaluation.

Secondary Outcomes (2)

  • Feeding Strategies Quesstionnaire

    The scale will be applied 3 times in total: at the beginning of the study, 10 weeks after the first evaluation and 4 weeks after the second evaluation.

  • Parental Self-Efficacy Scale

    The scale will be applied 3 times in total: at the beginning of the study, 10 weeks after the first evaluation and 4 weeks after the second evaluation.

Study Arms (2)

Research Group

EXPERIMENTAL

Mothers who will receive a 10-week occupational therapy-based parent coaching intervention will be included in this group.

Behavioral: Ergotherapy Based Parent Coaching

Control Group

OTHER

The control group will not receive an active intervention, but will be provided with an informative brochure on early childhood development. Additionally, once the research is completed, the right to participate in the intervention will be granted.

Other: Informative Brochure Distribution

Interventions

Occupational Therapy Based Parent Coaching intervention will last 10 sessions and will be carried out on the online platform. Sessions are planned to last between 45-60 minutes. The interviews to be held during the sessions are considered as the basic principles of parent coaching; It will be carried out in line with the principles of joint planning, observation, implementation, reflection and feedback. This intervention aims to educate mothers on proper feeding strategies for their children and to enable them to carry out these practices independently.

Also known as: Informative Brochure Distribution
Research Group

No active intervention will be made to the mothers in the target group; an informative brochure about early childhood development will be distributed.

Control Group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOur intervention is aimed at mothers of children with a history of premature birth.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Prematurity of the child (Birth week \<37)
  • The child is between 3-6 years old
  • The mother must have the competence to use online platforms, technological tools and internet connection.
  • The mother must have sufficient education to read, understand and fill out the scales.
  • Mothers reporting complaints about feeding problems in their children

You may not qualify if:

  • It may affect the child's feeding; Having a food allergy, disability, neurodevelopmental disease, chromosomal or structural anomalies
  • The child is fed non-orally
  • Being receiving occupational therapy, oral motor therapy or nutritional therapy at any center
  • Not allowing practices such as video sharing, camera/audio sharing, and recording of sessions during the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Medipol University

Ankara, Ankara/ Altındağ, 06110, Turkey (Türkiye)

Location

Related Publications (2)

  • Walton K, Daniel AI, Mahood Q, Vaz S, Law N, Unger SL, O'Connor DL. Eating Behaviors, Caregiver Feeding Interactions, and Dietary Patterns of Children Born Preterm: A Systematic Review and Meta-Analysis. Adv Nutr. 2022 Jun 1;13(3):875-912. doi: 10.1093/advances/nmac017.

    PMID: 35157009BACKGROUND
  • Dev DA, Padasas I, Hillburn C, Stage VC, Dzewaltowski DA. Ecological Approach to Family-Style, Multilevel Child Care Intervention: Formative Evaluation Using RE-AIM Framework. J Nutr Educ Behav. 2022 Aug;54(8):728-744. doi: 10.1016/j.jneb.2022.03.005. Epub 2022 Jun 26.

    PMID: 35768329BACKGROUND

MeSH Terms

Conditions

Feeding BehaviorFeeding and Eating DisordersPremature Birth

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Gökçen Akyürek, Ph. D.

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 20, 2024

Study Start

July 29, 2024

Primary Completion

June 22, 2025

Study Completion

August 15, 2025

Last Updated

January 21, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations