i-MaCHeL Study is a Two-group, Cluster-RCT, Involves 460 Preschool's Child-parent Dyads, to Prevent Childhood Obesity (i-MaCHeL)
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ClinicalTrials.gov Identifier: NCT04711525 |
Recruitment Status : Unknown
Verified February 2022 by Universiti Sultan Zainal Abidin.
Recruitment status was: Recruiting
First Posted : January 15, 2021
Last Update Posted : March 2, 2022
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Condition or disease | Intervention/treatment | Phase |
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Childhood Obesity Prevention | Behavioral: Experimental Group: Interactive Malaysian Childhood Healthy Lifestyle Program (i-MaCHeL) Behavioral: Control Group: Standard health education | Not Applicable |
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Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 460 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Masking Description: | 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. |
Primary Purpose: | Prevention |
Official Title: | Interactive Malaysian Childhood Healthy Lifestyle Program (i-MaCHeL) Intervention for Preschool's Child-parent Dyads to Prevent Childhood Obesity: A Cluster-randomized Controlled Trial |
Estimated Study Start Date : | March 16, 2022 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | December 31, 2022 |
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Arm | Intervention/treatment |
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Experimental: Interactive Malaysian Childhood Healthy Lifestyle Program (i-MaCHeL)
The preschool children in the experimental group will be exposed to interactive classroom instruction, and their parents will be exposed to the Web-based program. In the experimental group, apart from the standard preschool health education curriculum, the preschool children will also be exposed to the interactive activities and quizzes using Web 2.0 tools, educational videos of a healthy lifestyle, sensory-based food education activities, cooking demonstrations, fun, and active games, and exercises. Whereas the parents will be exposed to Web-based healthy lifestyle educational materials, videos, and pictures sharing, quizzes, and communication through the WhatsApp and closed Facebook groups. Besides, a total of 3 messages per week will be delivered to the parents in the experimental group. The messages will be included announcing the release of a new topic, a reminder to log in to the website and read the health information, and a reminder to participate in the online activities.
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Behavioral: Experimental Group: Interactive Malaysian Childhood Healthy Lifestyle Program (i-MaCHeL)
The preschool children in the experimental group 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. |
Active Comparator: Standard health education
The children in the control group do not have exposed to the i-MaCHeL interactive classroom instruction, and their parents do not have access to the i-MaCHeL website materials. Thus, the children will be continued with standard health education only in the preschool setting, and their parents will be received Web-based health newsletters. The Web-based newsletters consist of general health information that are relevant to the preschool life stage. In ensuring that the experimental and control groups appear the same, the topics in the Web-based newsletters will have a look and feel similar nature to the experimental group condition. But still, the topics will not be included the interactive components such as videos and pictures sharing activities, quizzes, individualized feedback, and communication through WhatsApp and closed Facebook groups. Only one message (announcement of the release of a new topic) per week will be delivered to parents of the control group.
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Behavioral: Control Group: Standard health education
The children in the control group will be continued with standard health education only in the preschool setting, and their parents will be received general Web-based health newsletters. |
- Changes in child BMI-for-age z-score [ Time Frame: 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).
- Changes in child dietary intake [ Time Frame: 3-month and 9-month after baseline ]Dietary intake information of the children will be obtained from a three-day food record (two weekdays and one weekend) and the average measurement will be taken. A dietary analysis software, Nutritionist Pro Inc. will be used for energy and nutrient analysis.
- Changes in child physical activity [ Time Frame: 3-month and 9-month after baseline ]Child physical activity duration (including light-, moderate-, and vigorous-intensity) and sedentary behavior (screen time spent in front of a television, computer, tablet, or video game) will be assessed using a validated Preschool-age Physical Activity Questionnaire (Pre-PAQ), a parent-proxy questionnaire. The parents will be required to report on the time spent (in minutes) in the activities their child did "yesterday" and "last weekend". A 3-day mean for the activities will be calculated as an average of one weekday, Saturday, and Sunday. The different kinds of physical activity are categorized into 5 levels: 1. Sedentary - no movement; 2. Sedentary play - limb or trunk moving; 3. Moving slowly; 4. Moving at a moderate pace and; 5. Moving at a fast pace.
- Changes in child health-related quality of life (HRQOL) [ Time Frame: 3-month and 9-month after baseline ]Child Health-Related Quality of Life (HRQOL) will be assessed using a validated Quality of Life Inventory Version 4.0 (PedsQL) Generic Core Scales, a parent-proxy questionnaire. A 5-point response scale is utilized (0 = never a problem; 4 = always a problem). The Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) so that a higher score indicates better HRQOL functioning.
- Changes in parental self-efficacy [ Time Frame: 3-month and 9-month after baseline ]Parental self-efficacy will be assessed using a validated Parental Self-Efficacy for Healthy Dietary and Physical Activity Behaviors in Preschoolers Scale (PDAP), a parent-proxy questionnaire. An 11-point Likert scale will be used to record responses, ranging from 0 (not at all confident) to 10 (completely confident). Twelve of the 21 items from the questionnaire will be summed to yield separate scores for parental self-efficacy for promoting child physical activity, and the other 9 items will be summed to yield scores for parental self-efficacy for promoting child's healthy eating.
- Changes in parental role modeling [ Time Frame: 3-month and 9-month after baseline ]Parental role modeling will be assessed using a validated Home Environment Survey (HES), a parent-proxy questionnaire. A 5-point Likert scale will be utilized for parental role modeling items with responses ranging from "never" (0) to "always" (4).
- Changes in parental policies [ Time Frame: 3-month and 9-month after baseline ]Parental policies will be assessed using a validated Home Environment Survey (HES), a parent-proxy questionnaire. A 5-point Likert scale will be utilized for parental policy items with responses ranging from "never" (0) to "always" (4).
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Ages Eligible for Study: | 5 Years to 49 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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
Exclusion Criteria:
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04711525
Contact: Ahmad Faezi Ab.Rashid | +601165511200 | faezi.ar@umk.edu.my | |
Contact: Sharifah Wajihah Wafa Syed Saadun Tarek Wafa | +60126911510 | sharifahwajihah@unisza.edu.my |
Malaysia | |
Universiti Sultan Zainal Abidin | Recruiting |
Kampung Gong Badak, Terengganu, Malaysia, 21300 | |
Contact: NUR AFIQAH NOROZI +6096688515 afiqah@unisza.edu.my | |
Contact: AFIFAH MOHD YUSOFF +6096688556 afifahmyusoff@unisza.edu.my |
Principal Investigator: | AHMAD FAEZI AB.RASHID | Universiti Sultan Zainal Abidin |
Responsible Party: | Universiti Sultan Zainal Abidin |
ClinicalTrials.gov Identifier: | NCT04711525 |
Other Study ID Numbers: |
UniSZA/UHREC/2020/184 |
First Posted: | January 15, 2021 Key Record Dates |
Last Update Posted: | March 2, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Obesity Preschool children Web based program Body Mass Index Dietary intake |
Physical activity Health related quality of life Self efficacy Role modeling Cluster randomized controlled trial |
Obesity Pediatric Obesity Overweight |
Overnutrition Nutrition Disorders Body Weight |