Empowering Parents to Optimize Feeding Practices With Preschool Children (EPO Feeding Program)

Feeding Practices Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06181773
• Other study ID #: 20231019
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2023
• Est. completion date: April 2024

Study information

• Verified date: October 2023
• Source: King's College London
• Contact: Jian Wang
• Phone: +44(0)7522509450
• Email: jian.3.wang[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 novel intervention (group-based training) - 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.

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) implementation 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' 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Parents Inclusion Criteria:

1. Parents who are the caregivers (caregivers (i.e., parents who are responsible for the family food environment and their preschool children's eating

2. 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)

3. Parents are aged =18 years

4. Able to provide informed consent

5. Able to speak and write Chinese

Exclusion Criteria:

1. Parents with diagnosed severe mental illness such as schizophrenia, uncontrolled bipolar disorder, or mental retardation that would prevent participation in the feasibility intervention.

2. Their preschool children with diseases that influence their eating and nutrition (e.g., diagnosed eating disorders).

3. Parents who have eating disorders or are pregnant during the study period.

4. Parents or parents with children who are participating in another intervention related to child growth and nutrition.

5. Parents who have participated in previous aspects of the intervention development (e.g., focus groups).

Related Conditions & MeSH terms

• Feeding Practices

Intervention

Behavioral:
• EPO Feeding Program
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.

Locations

Country	Name	City	State
China	YangZhou Baoying Maternal and Child Health Hospital	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The feasibility and acceptability of EPO Feeding program: Observation checklist	Process evaluation: observation checklist. The researcher will make fieldnotes about the module delivery and responses to the modules provided on the program, barriers and enablers of the program completion, participants' task engagement and its overall structure, delivery, and content of the program.	Week 1,2,3,4 (record in each intervention)
Other	The feasibility and acceptability of EPO Feeding program: Fidelity checklist	The fidelity checklist of the EPO Feeding program delivery will be used to measure how closely they adhere to the manual and the underpinned theoretical models. All modules will be audio recorded by a facilitator and watched by another researcher to rate against the fidelity checklists and ensure modules are delivered as intended.	Week 4,5 (after intervention)
Primary	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)
Primary	Attendance/Adherence	Number of modules attended	Attendance record in each module (week 1,2,3,4)
Primary	Recruitment rate	Recruitment rates: The percentage of participants take part in the intervention.	Baseline
Primary	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)
Primary	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)
Primary	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)
Primary	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	Parental feeding practices	The Chinese Preschoolers' Caregivers' Feeding Behavior Scale (CPCFBS) will be used to evaluate parental restrictive feeding, pressure to eat, monitoring, encouragement of healthy eating and modeling. The Chinese version of the Child Feeding Questionnaire (C-CFQ) will be used to assess use of food as a reward. Each item of CPCFBS and C-CFQ is rated on a 5-point Likert scale. The response options for each item are 1"never", 2"rarely", 3"sometimes", 4"usually", and 5"always". Each subscale is calculated by averaging the scores of all the items in that subscale with higher scores indicating a greater prevalence of that feeding practice. (positive/responsive feeding: monitoring, encouragement of healthy eating and modeling; negative/non-responsive feeding: restrictive feeding, pressure to eat and reward)	Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
Secondary	Parental self-reported perception of preschool child weight	The Chinese version of the Child Feeding Questionnaire (C-CFQ) will be used to measure self-reported perception of child weight by asking, "How would you describe your child's weight?". Each item is rated on a 5-point Likert scale. The responses include 1"very underweight," 2"slightly underweight," 3"normal weight," 4"slightly overweight," and 5"very overweight."	Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
Secondary	Parental visual perception of child weight	Parental visual perception of child weight will be assessed by the perception of Healthy Weight (PPHW) in the age range 2 to 6 years old. The parent will be asked to select one gender from an appropriate image/sketch that most closely matches the child's body type on a 7-point scale (1 = a severely underweight child, 4 = an average-weight child, 7 = an obese child).	Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
Secondary	Parenting Sense of Competence	The Chinese version of Parenting Sense of Competence Scale will be used to assess parental perception of their abilities to manage the demands of parenting. It includes two subscales: Efficacy and Satisfaction. Each item is rated on a 6-point Likert scale from "Absolutely disagree" to "Absolutely agree". Each subscale is calculated by averaging the scores of all the items in that subscale with higher scores indicating a greater efficacy and satisfaction of parenting role.	Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
Secondary	Child eating behaviors	Five types of child eating behaviors are assessed by the Chinese Preschoolers' Eating Behavior Questionnaire (CPEBQ), including food fussiness, satiety responsiveness, food responsiveness, emotional eating and initiative eating. Each item is rated on a 5-point Likert scale with higher scores indicating a greater prevalence of that eating behavior. The response options for each item are 1"never", 2"rarely", 3"sometimes", 4"usually", and 5"always". Each subscale is calculated by averaging the scores of all the items in that subscale. (positive eating behaviors: initiative eating; negative eating behaviors: food fussiness, satiety responsiveness, food responsiveness, and emotional eating)	Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
Secondary	Child weight status	BMI Z-scores are categorized into three groups: underweight (Z-score < -2), normal weight (-2 = Z-score = 1), overweight (1 < Z-score = 2) and obese (Z-score > 2)	Baseline, after intervention (week 4), and one-month follow-up (week 8,9)