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

NCT04711525 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2022-03-02

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Universiti Sultan Zainal Abidin

    lead OTHER

Principal Investigators

  • AHMAD FAEZI AB.RASHID · Universiti Sultan Zainal Abidin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-16
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Malaysia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04711525 on ClinicalTrials.gov