Clinical trial NCT06181773: Empowering Parents to Optimize Feeding Practices With Preschool Children (EPO Feeding Program)
Official title: Development and Feasibility Testing of Intervention on Improving Caregivers' Perception of Preschool Child Weight and Their Feeding Practices in Yangzhou City, China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Practices
Keywords: Feeding practices
Preschool children
Group-based training program
Caregivers
Parents
Weight perception
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants will be randomly allocated to two arms: the intervention group and the control group.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Retention rate
timeFrame: Record in each module (week 1,2,3,4); retention rate will be caculated after completing intervention (week4)
measure: Attendance/Adherence
timeFrame: Attendance record in each module (week 1,2,3,4)
measure: Recruitment rate
timeFrame: Baseline
measure: Participants Acceptance of Intervention
timeFrame: Week 4 (after intervention)
measure: Participants Acceptance of Intervention2
timeFrame: Week 4,5 (after intervention)
measure: Provider Acceptance of Intervention (healthcare professionals)
timeFrame: Week 4,5 (after intervention)
measure: The completion rates of the outcome measures
timeFrame: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
Secondary outcomes:
measure: Parental feeding practices
timeFrame: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
measure: Parental accurate perception of preschool child weight (self-reported)
timeFrame: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
measure: Parental accurate perception of child weight (visual)
timeFrame: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
measure: Parenting Sense of Competence
timeFrame: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
measure: Child eating behaviors
timeFrame: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
measure: Child weight status
timeFrame: Baseline, after intervention (week 4), and one-month follow-up (week 8,9)
Other outcomes:
measure: The feasibility and acceptability of EPO Feeding program: Observation checklist
timeFrame: Week 1,2,3,4 (record in each intervention)
measure: The feasibility and acceptability of EPO Feeding program: Fidelity checklist
timeFrame: Week 6-7 (after intervention)
measure: The feasibility and acceptability of EPO Feeding program: Progress criteria assessment
timeFrame: Week 13-14 (after follow-up measurement)
Locations:
city: Yangzhou
country: China
facility: YangZhou Baoying Maternal and Child Health Hospital
state: Jiangsu
Study officials:
affiliation: King's College London
name: Jian Wang
role: PRINCIPAL_INVESTIGATOR
References: