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Clinical Trials/NCT06181773
NCT06181773
Completed
Not Applicable

Development and Feasibility Testing of Intervention on Improving Caregivers' Perception of Preschool Child Weight and Their Feeding Practices in Yangzhou City, China

King's College London1 site in 1 country84 target enrollmentDecember 8, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Feeding Practices
Sponsor
King's College London
Enrollment
84
Locations
1
Primary Endpoint
Attendance/Adherence
Status
Completed
Last Updated
last year

Overview

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.

Detailed Description

The development process of the EPO Feeding program was conducted according to the MRC framework and included a systematic review of the relevant literature and stakeholder participation through qualitative interviews with parents and healthcare professionals and focus groups with kindergarten staff. The cross-sectional study was also conducted to determine if parental perception of child weight had a close link to their specific feeding practices. It also provided information on the frequency of specific feeding practices in the research setting, which aided inform the prioritization of intervention content. After structuring the EPO Feeding program, more stakeholders were engaged to further refine the intervention before designing the feasibility RCT. After completing the baseline assessment, parents of preschool children who are responsible for their child's eating behaviors and family food environment will be randomized and allocated to one of the groups through a concealed computerized random number generator. 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. Parents will complete the measures immediately after the 4-week program, and at one-month follow-up. The primary outcomes are i) feasibility measured through retention rates and adherence; ii) acceptability of the program to parents and the healthcare professionals delivering the program through an anonymous survey, qualitative process evaluation, and fidelity of intervention delivery. The secondary outcomes focus on the potential program effects on i) parental feeding practices; ii) parents' accurate perception of their child's weight; iii) parenting sense of competence; iv) parental accounts of their child's eating behaviors; and v) children's BMI-Z scores.

Registry
clinicaltrials.gov
Start Date
December 8, 2023
End Date
March 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

Attendance/Adherence

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

Number of modules attended

Participants Acceptance of Intervention2

Time Frame: Week 4,5 (after intervention)

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).

Retention rate

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

The percentage of participants who complete the intervention.

The completion rates of the outcome measures

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

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

Recruitment rate

Time Frame: Baseline

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

Participants Acceptance of Intervention

Time Frame: Week 4 (after 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.

Provider Acceptance of Intervention (healthcare professionals)

Time Frame: Week 4,5 (after intervention)

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).

Secondary Outcomes

  • Child weight status(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))
  • 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))
  • 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))

Study Sites (1)

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