i-MaCHeL Study is a Two-group, Cluster-RCT, Involves 460 Preschool's Child-parent Dyads, to Prevent Childhood Obesity

NCT04711525 | Unknown

• 1 other identifier: UniSZA/UHREC/2020/184
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Childhood Obesity Prevention

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Changes in child BMI-for-age z-score

  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).

  3-month and 9-month after baseline

Secondary Outcomes (6)

• 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

Study Arms (2)

Interactive Malaysian Childhood Healthy Lifestyle Program (i-MaCHeL)

EXPERIMENTAL

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.

Behavioral: Experimental Group: Interactive Malaysian Childhood Healthy Lifestyle Program (i-MaCHeL)

Standard health education

ACTIVE COMPARATOR

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.

Behavioral: Control Group: Standard health education

Interventions

Experimental Group: Interactive Malaysian Childhood Healthy Lifestyle Program (i-MaCHeL) BEHAVIORAL

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.

Interactive Malaysian Childhood Healthy Lifestyle Program (i-MaCHeL)

Control Group: Standard health education BEHAVIORAL

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.

Standard health education

Eligibility Criteria

• Age: 5 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sultan Zainal Abidin: lead

Study Sites (1)

Universiti Sultan Zainal Abidin

Kampung Gong Badak, Terengganu, 21300, Malaysia

RECRUITING

Related Publications (2)

• Rashid AFA, Syed Saadun Tarek Wafa SWW, Talib RA, Bakar NMA. Interactive Malaysian Childhood Healthy Lifestyle (i-MaCHeL) programme: a single-arm pilot study. Pilot Feasibility Stud. 2024 May 18;10(1):80. doi: 10.1186/s40814-024-01483-7.

  PMID: 38762727 DERIVED

• Rashid AF, Wafa SW, Abd Talib R, Abu Bakar NM. An interactive Malaysian Childhood Healthy Lifestyle (i-MaCHeL) intervention programme to change weight-related behaviour in preschool child-parent dyads: Study protocol of a cluster randomised controlled trial. PLoS One. 2022 Oct 31;17(10):e0276843. doi: 10.1371/journal.pone.0276843. eCollection 2022.

  PMID: 36315523 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• AHMAD FAEZI AB.RASHID

  Universiti Sultan Zainal Abidin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad Faezi Ab.Rashid

CONTACT

+601165511200; faezi.ar@umk.edu.my

Sharifah Wajihah Wafa Syed Saadun Tarek Wafa

CONTACT

+60126911510; sharifahwajihah@unisza.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2021
• First Posted: January 15, 2021
• Study Start: March 16, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)