Feeding PracticesNCT06181773
Empowering Parents to Optimize Feeding Practices With Preschool Children (EPO Feeding Program)
A study testing EPO Feeding Program in people with Feeding Practices, run by King's College London at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Feeding Practices
- What is being tested?
- EPO Feeding Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2023to 31 Mar 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
YangZhou Baoying Maternal and Child Health Hospital
Yangzhou, Jiangsu, 225800
About this study
Official title: Development and Feasibility Testing of Intervention on Improving Caregivers' Perception of Preschool Child Weight and Their Feeding Practices in Yangzhou City, China
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.
Read the 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.
- Conditions
- Feeding Practices
- Being tested
- EPO Feeding Program
- Keywords
- Feeding practices, Preschool children, Group-based training program, Caregivers, Parents, Weight perception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPO Feeding ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate
The percentage of participants who complete the intervention.
Measured: Record in each module (week 1,2,3,4); retention rate will be caculated after completing intervention (week4)
Attendance/Adherence
Number of modules attended
Measured: Attendance record in each module (week 1,2,3,4)
Recruitment rate
Recruitment rates: The percentage of participants take part in the intervention.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Week 4,5 (after intervention)
The completion rates of the outcome measures
The percentage of the participants complete the questionnaires at each time point.
Measured: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
Secondary outcomes (6)
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)
Measured: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
Parental accurate perception of preschool child weight (self-reported)
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."
Parental accurate perception of child weight was assessed by determining the discrepancy between their perceptions of child weight and the child's actual weight status. A score of zero indicated non-misperceptions, while negative or positive scores indicated misperceptions.
Measured: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
Parental accurate perception of child weight (visual)
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).
Parental accurate perception of child weight was assessed by determining the discrepancy between their perceptions of child weight and the child's actual weight status. A score of zero indicated non-misperceptions, while negative or positive scores indicated misperceptions.
Measured: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
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.
Measured: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
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)
Measured: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
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)
Measured: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start8 Dec 2023
- Primary completion7 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Feeding PracticesStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be randomly allocated to two arms: the intervention group and the control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Wang, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181773
- Sponsor's protocol ID
- 20231019
- Status last verified
- Oct 2023
- First submitted
- 20 Nov 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41503735Wang 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.
PubMed 38829882
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility Testing of Intervention on Improving Caregivers' Perception of Preschool Child Weight and Their Feeding Practices in Yangzhou City, China
- ClinicalTrials.gov ID
- NCT06181773
- Acronym / sponsor ID
- 20231019
- Conditions
- Feeding Practices
- Keywords
- Feeding practices, Preschool children, Group-based training program, Caregivers, Parents, Weight perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 26 Dec 2023 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The participants will be randomly allocated to two arms: the intervention group and the control group.
| Arm | Type | Receives |
|---|---|---|
| EPO Feeding program + Usual care (intervention group) | Experimental | Behavioral: EPO Feeding ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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).
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 |
|---|---|---|
| EPO Feeding ProgramThe 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. | Behavioural | EPO Feeding program + Usual care (intervention group) |
Primary outcome
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.
Attendance/Adherence
Time frame: Attendance record in each module (week 1,2,3,4)
Number of modules attended
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.
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).
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).
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.
6 secondary outcomes
Parental feeding practices
Time frame: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
Parental accurate perception of preschool child weight (self-reported)
Time frame: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
Parental accurate perception of child weight (visual)
Time frame: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
Parenting Sense of Competence
Time frame: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
Child eating behaviors
Time frame: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
Child weight status
Time frame: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
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 13 Aug 2024.
- Derived from this study: PubMed 41503735Wang 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.
- Derived from this study: PubMed 38829882Wang 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.
- Individual participant dataSharing planned: No
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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.
Jian Wang principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPO Feeding Program in people with Feeding Practices, run by King's College London at 1 site in China.
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 0 inclusion and 5 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 13 Aug 2024. 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 China. 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?
Retention rate (time frame: Record in each module (week 1,2,3,4); retention rate will be caculated after completing intervention (week4)). The study lists 7 primary outcomes in all. 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 NCT06181773, which also lists 2 linked publications.
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 13 Aug 2024.