PEaters Choice™: Randomized Control Trial to Improve Picky Eating Behaviour Among Children Aged 3-5 Years
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Change of food repertoire from baseline at sixth weeks
研究概览
简要总结
Picky eaters (PE) are defined as individuals with a lack of diversity in food intake and fear of trying new foods which generally leads to malnutrition. Globally, between 20% to 55% of children worldwide are being reported as PE. Malaysia particularly has 31.8% PE children. To date, limited comprehensive modules on dietary recommendations are designed to help parents and/or primary healthcare workers to address this issue. This study is a single-blind randomized controlled trial to evaluate the effectiveness of PEaters Choice™ designed for PE children aged three to five years, with the objective to increase the food repertoire of the children. The PEaters Choice™ is a 12-week intervention program designed for mother, father or guardian-child dyads. The dyads will be divided into two groups; Intervention and Control Group. This trial will require each group to complete a list of commonly eaten foods, Child Eating Behavior Questionnaires, and a set of anthropometric data. Intervention groups will then follow three phases of the intervention program. This module suits primary healthcare settings, helping parents or guardians strategize meal planning, hence lowering the risk of malnutrition among PE children.
详细描述
The study will be conducted at the UKM Specialist Children's Hospital (HPKK UKM) in Kuala Lumpur to simulate real-life situations for this module. All briefings, therapies, and activities will be conducted in this setting. Considering several factors, especially subjects' commitment to attend the prescribed session, the selected area to participate in the study is a 5km radius from HPKK UKM.
The study information sheet and consent form are written in Malay, the Malaysian national language, and in the English language. The head researcher is responsible for the consent process and answering all relevant questions. However, other researchers will also assist in conveying this information from time to time. After the briefing session, mother, father or guardian will be given time to understand and ask any questions related to the study. If the parents or guardians feel it is necessary to take a longer time before making a decision, they may also take the study information form and consent form home.
Sample size calculation using the G-Power program (95% confidence interval, 80% power) found a minimum of 138 subjects required. The study sample was increased by 10%, considering the dropout factors to 154 subjects (77 people for each group).
The dyads who have consented to participate in the study will be placed in the same age nursery or kindergartens group and randomly selected to participate in intervention groups. Children in the same nursery/kindergarten will receive the same intervention. As the intervention will be conducted by the researcher, the dyads will not be informed (blinded) of their type of intervention.
The research team will manage all data. Data will be entered into the SPSS program by the researcher and reviewed by the head researcher. Questionable data will be confirmed with original forms or relevant sources. Outlier data that is deemed unreasonable will be removed and marked as missing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are between three and five years old
- •Subjects had PE problems (screened using the CEBQ)
排除标准
- •subject has clinical health problems such as autism, down syndrome, global developmental delay, dyslexia, or any health problem interfering with eating habits.
结局指标
主要结局
Change of food repertoire from baseline at sixth weeks
时间窗: The list will be collected at the sixth weeks.
List of food eaten by the subject
Change of food repertoire from baseline at 12th weeks
时间窗: The list will be collected the 12th weeks.
List of food eaten by the subject
次要结局
- Change of weight-for-age (z-scores) from baseline at sixth weeks(It will be collected at the sixth weeks)
- Change of weight-for-age (z-scores) from baseline at 12th weeks(It will be collected at the 12th weeks)
- Change of height-for-age (z-scores) from baseline at sixth weeks(It will be collected at the sixth weeks)
- Change of children's eating behaviors (CEBQ) from baseline at 12th weeks(It will be collected at the 12th weeks)
- Change of BMI-for-age (z-scores) from baseline at sixth weeks(It will be collected at the sixth weeks)
- Change of BMI-for-age (z-scores) from baseline at 12th weeks(It will be collected at the 12th weeks)
- Change of children's eating behaviors (CEBQ) from baseline at sixth weeks(It will be collected at the sixth weeks)
- Change of weight-for-height (z-scores) from baseline at sixth weeks(It will be collected at the sixth weeks)
- Change of height-for-age (z-scores) from baseline at 12th weeks(It will be collected at the 12th weeks)
- Change of weight-for-height (z-scores) from baseline at 12th weeks(It will be collected at the 12th weeks)
研究者
Dr Nur Hana Hamzaid
Principal Investigator
National University of Malaysia