NCT06181773

Brief Summary

Parental feeding practices are critical in shaping preschool children's eating habits and preventing childhood obesity. However, parents frequently adopt inappropriate feeding practices that are not optimal for their children's health and may result in children's nutrition-related problems. Thus, the research team developed a psychoeducational intervention - Empowering Parents to Optimize Feeding Practices with Preschool Children (EPO Feeding program) to support healthier feeding practices. The primary objective of this study is to test the feasibility and acceptability of the EPO Feeding program. The secondary objective is to test the potential effects of the EPO Feeding program against a control group, on parental feeding practices, parental perception of their child's weight, parenting sense of competence, their child's eating behaviors, and their child's BMI-Z scores.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

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

November 20, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

December 8, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2024

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

August 13, 2024

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

November 20, 2023

Last Update Submit

August 9, 2024

Conditions

Keywords

Feeding practicesPreschool childrenGroup-based training programCaregiversParentsWeight perception

Outcome Measures

Primary Outcomes (7)

  • Retention rate

    The percentage of participants who complete the intervention.

    Record in each module (week 1,2,3,4); retention rate will be caculated after completing intervention (week4)

  • Attendance/Adherence

    Number of modules attended

    Attendance record in each module (week 1,2,3,4)

  • Recruitment rate

    Recruitment rates: The percentage of participants take part in the intervention.

    Baseline

  • Participants Acceptance of Intervention

    An anonymous survey containing eight closed questions (e.g., How would you rate the quality of the program? How valuable was the program in helping you optimise feeding practices?) and one open question (i.e., comments on the experiences or feelings about the program) after the intervention. Each item is rated on a 10-point Likert scale. The acceptability will be calculated by averaging the scores of all the items with higher scores indicating greater acceptability of the program.

    Week 4 (after intervention)

  • Participants Acceptance of Intervention2

    Process evaluation of the program: semi-structured interviews with participants. The interview topic guide will be used to instruct the interview (e.g., participants' advice and suggestions on the program, outcome measures, and randomization).

    Week 4,5 (after intervention)

  • Provider Acceptance of Intervention (healthcare professionals)

    Process evaluation of the program: semi-structured interviews with healthcare professionals who will deliver the program (e.g., their advice and suggestions on the program).

    Week 4,5 (after intervention)

  • The completion rates of the outcome measures

    The percentage of the participants complete the questionnaires at each time point.

    Baseline, after intervention (week 4), and one-month follow-up (week 8,9)

Secondary Outcomes (6)

  • Parental feeding practices

    Baseline, after intervention (week 4), and one-month follow-up (week 8,9)

  • Parental accurate perception of preschool child weight (self-reported)

    Baseline, after intervention (week 4), and one-month follow-up (week 8,9)

  • Parental accurate perception of child weight (visual)

    Baseline, after intervention (week 4), and one-month follow-up (week 8,9)

  • Parenting Sense of Competence

    Baseline, after intervention (week 4), and one-month follow-up (week 8,9)

  • Child eating behaviors

    Baseline, after intervention (week 4), and one-month follow-up (week 8,9)

  • +1 more secondary outcomes

Other Outcomes (3)

  • The feasibility and acceptability of EPO Feeding program: Observation checklist

    Week 1,2,3,4 (record in each intervention)

  • The feasibility and acceptability of EPO Feeding program: Fidelity checklist

    Week 6-7 (after intervention)

  • The feasibility and acceptability of EPO Feeding program: Progress criteria assessment

    Week 13-14 (after follow-up measurement)

Study Arms (2)

EPO Feeding program + Usual care (intervention group)

EXPERIMENTAL

Participants in the intervention group will receive the EPO Feeding program and usual care. EPO Feeding program includes four, weekly group training sessions for parents of preschool children (aged 2-6) led by healthcare professionals. The intervention incorporates lessons and information (i.e., slide shows and handouts), group discussions, motivational interviewing, and other supplementary materials (e.g., stories, key messages, and educational videos) to improve parents' knowledge, skills, and behaviors regarding feeding preschool children. After each module, homework activities will be assigned to participants to help reinforce their knowledge, skills, and behaviors. The motivational interviewing will be conducted by healthcare professionals to provide individual support. Moreover, a WeChat group will be set up to facilitate parental involvement, learning, and communication.

Behavioral: EPO Feeding Program

Usual care (control group)

NO INTERVENTION

Parents involved in the control group will receive usual care, which is the printed materials of child health-related dietary recommendations published by the Chinese government/Nutrition Society. These materials will also be distributed to the participants in the intervention group. After the final data collection at one-month follow-up, participants from this control group will be offered the complete material package of the EPO Feeding program, their child's weight status measured at the final time point and provided access to pre-recorded modules by healthcare professionals as a incentive.

Interventions

The EPO Feeding program focused on providing parents with information based on scientific evidence and the most current nutritional recommendations regarding positive feeding practices and healthy eating during the preschool years.

EPO Feeding program + Usual care (intervention group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents who are the caregivers (caregivers (i.e., parents who are responsible for the family food environment and their preschool children's eating
  • One of their children aged 2 to 6 years (if (more than) two preschool children, the parent is instructed to focus on the child whose eating, nutrition or weight status they are more concerned about)
  • Parents are aged ≥18 years
  • Able to provide informed consent
  • Able to speak and write Chinese

You may not qualify if:

  • Parents with diagnosed severe mental illness such as schizophrenia, uncontrolled bipolar disorder, or mental retardation that would prevent participation in the feasibility intervention.
  • Their preschool children with diseases that influence their eating and nutrition (e.g., diagnosed eating disorders).
  • Parents who have eating disorders or are pregnant during the study period.
  • Parents or parents with children who are participating in another intervention related to child growth and nutrition.
  • Parents who have participated in previous aspects of the intervention development (e.g., focus groups).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

YangZhou Baoying Maternal and Child Health Hospital

Yangzhou, Jiangsu, 225800, China

Location

Related Publications (2)

  • Wang J, Chang YS, Wei X, Cao Y, Winkley K. Feasibility of a Psychoeducational Intervention for Empowering Parents to Optimise Feeding Practices in China: A Randomised Controlled Feasibility Trial. Matern Child Nutr. 2026 Mar;22(1):e70155. doi: 10.1111/mcn.70155.

  • Wang J, Cao Y, Wei X, Winkley K, Chang YS. Empowering parents to optimize feeding practices with preschool children (EPO-Feeding): A study protocol for a feasibility randomized controlled trial. PLoS One. 2024 Jun 3;19(6):e0304707. doi: 10.1371/journal.pone.0304707. eCollection 2024.

Study Officials

  • Jian Wang

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the study, only the research members who collect and analyze the data from participants can be masked to the randomization.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The participants will be randomly allocated to two arms: the intervention group and the control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

December 26, 2023

Study Start

December 8, 2023

Primary Completion

March 7, 2024

Study Completion

March 31, 2024

Last Updated

August 13, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations