Interactive Malaysian Childhood Healthy Lifestyle Program (i-MaCHeL) Intervention for Preschool's Child-parent Dyads to Prevent Childhood Obesity: A Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 460
- 试验地点
- 2
- 主要终点
- Changes in child BMI-for-age z-score
研究概览
简要总结
Background: Strategies to treat and prevent obesity are urgently required in Malaysia, and it is now considered a public health priority. Aims: The present study aims to evaluate the effectiveness of the i-MaCHeL intervention for preschool's child-parent dyads. The primary objective of the present study is to compare the changes in the child BMI-for-age z-score at 3- and 9-month after baseline measurement. The secondary objectives of the present study are to compare the changes in child dietary intake, child physical activity, child health-related quality of life, parental self-efficacy, parental role modeling, and parental policies at 3- and 9-month after baseline measurement. Study design: The i-MaCHeL intervention is a single-blind, two-group cluster-randomized controlled trial that evaluates the effectiveness of a 3-month obesity prevention intervention on preschool's child-parent dyads at 3- and 9-month after baseline. The participating preschools (n=12) will be randomized to either the intervention or control group in a 1:1 ratio. The present study will involve 460 child-parent dyads of preschool children aged 5 and 6 years old and their parents in Terengganu, Malaysia. Briefly, the preschool children in the experimental group will be received the i-MaCHeL program delivered through interactive classroom instruction, and their parents will have access to the i-MaCHeL Web-based program. In the control group, the preschool children will be received a standard preschool health education curriculum, and their parents will have access to the general Web-based health newsletters. Instruments: Anthropometric measurements (body weight and height) will be assessed according to the WHO standard procedures. Dietary intake of children will be measured using dietary records for three days. Child physical activity, child health-related quality of life, parental role modeling, parental policies, and parental self-efficacy will be assessed using previously validated parent-proxy questionnaires. Conclusion: The strategies to promote healthy eating in reducing the prevalence of obesity among Malaysian preschool children may have long-term benefits to children's health. The combinations of the two modes of delivery (interactive classroom instruction for preschool children and a Web-based program for parents) will have a strong potential to be effective strategies to sustain child-parent engagement and participation in the health-related behavior change program.
详细描述
- Research Hypotheses
The primary hypothesis of the present study is that the preschool children in the i-MaCHeL intervention group would achieve a significant improvement in BMI z-score compared with those in the comparison group at 3- and 9-month after baseline measurement.
The secondary hypotheses of the present study, as stated below:
- Preschool children in the i-MaCHeL intervention group would achieve significant improvements in dietary intake, physical activity, and health-related quality of life compared with those in the comparison group at 3- and 9-month after baseline measurement.
- Parents of preschool children in the i-MaCHeL intervention group would achieve significant improvements in parental self-efficacy, parental role modeling, and parental policies compared with those in the comparison group at 3- and 9-month after baseline measurement.
- Study Location
Two districts, which are Kuala Terengganu and Kuala Nerus, will be included in this study. These two districts are chosen based on demographic and logistic factors as it is within 35 miles (56 kilometers) of the study center. 3. Reference Population
The reference population will be based on a sample population drawn from the MOE public preschools in the Terengganu that are registered at the Ministry of Education Malaysia (MOE). There are 307 MOE public preschools with a total of 11,600 children in Terengganu. All children attending MOE public preschool in the Kuala Terengganu and Kuala Nerus districts will be included as the reference population in the present study. 4. Source Population
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The single-blind RCT will be applied in the present study, in which the researcher but not the study participants know which intervention has been allocated at the preschool level. In the experimental group, the preschool children will be received the i-MaCHeL program delivers through interactive classroom instruction, and their parents will have access to the i-MaCHeL Web-based program. Whereas in the control group, the preschool children will be received a standard preschool health education curriculum, and their parents will have access to the general Web-based health newsletters.
入排标准
- 年龄范围
- 5 Years 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be included in the study, children have to be aged 5- or 6-years Malaysian citizens and attending MOE public preschools in the Kuala Terengganu and Kuala Nerus districts. Besides, the parent/guardian of the preschool children must:
- •Could read and understand either English or Malay
- •To be aged between 25 to 49 years
- •Have regular internet access via a tablet device, mobile phone, or computer/laptop
- •Have regular access to a phone with texting capability
- •Have WhatsApp and Facebook accounts or agreed to create the accounts
- •Comfortable to read/view materials on electronic devices
- •Willing to complete all questionnaires with their child throughout the study
排除标准
- •Child-parent dyads will be excluded if they have the following criteria:
- •Children that are taking medications or have a medical condition with the potential to affect the weight or restrict age-appropriate play
- •Children that are having conditions that require the restriction of certain foods (e.g., celiac disease or food allergies)
- •Parents that are suffering from a severe physical or psychological illness, making the study too demanding for the family
结局指标
主要结局
Changes in child BMI-for-age z-score
时间窗: 3-month and 9-month after baseline
Anthropometric measurements such as body weight and height will be assessed according to the standard procedures of the World Health Organization (1995). BMI will be calculated using the standard formula (kg/m2). BMI-for-age Z-score curve, according to the WHO references will be used to classify weight status. The child weight status will be categorized into four categories which are overweight (\> +1SD of BMI-for-age z-score), obese (\> +2SD of BMI-for-age z-score), thinness/wasting (\< -2SD of BMI-for-age z score) and normal weight (+1SD to -2SD of BMI-for-age z-score).
次要结局
- Changes in child dietary intake(3-month and 9-month after baseline)
- Changes in child physical activity(3-month and 9-month after baseline)
- Changes in child health-related quality of life (HRQOL)(3-month and 9-month after baseline)
- Changes in parental self-efficacy(3-month and 9-month after baseline)
- Changes in parental role modeling(3-month and 9-month after baseline)
- Changes in parental policies(3-month and 9-month after baseline)