NCT07641452

Brief Summary

The goal of this clinical trial is to learn whether an online family health education program can help Vietnamese children aged 7-9 years with overweight or obesity develop healthier habits. The main questions it aims to answer are:

  1. 1.Does the program improve parents' confidence, role modeling behaviors, family communication, and healthy family practices?
  2. 2.Does the program improve children's eating habits, physical activity, screen time, and body measurements related to overweight and obesity?
  3. 3.Complete surveys about their family's health habits and daily routines.
  4. 4.Attend health checkups that include measurements of height, weight, and waist size.
  5. 5.Receive either the online family health education program or standard health education materials.
  6. 6.Complete follow-up assessments after the program and four months later.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 2, 2026

Last Update Submit

June 10, 2026

Conditions

Keywords

childhood obesityfamily-centered interventionself-efficacyrole modelingmixed-methodsparent-mediated interventionVietnam

Outcome Measures

Primary Outcomes (2)

  • Child Body Mass Index-for-Age z-Score (BMI-for-Age z-Score)

    Child body mass index-for-age z-score will be calculated using the World Health Organization (WHO) growth reference for children aged 5-19 years. Body mass index (BMI) will first be calculated as body weight in kilograms divided by height in meters squared (kg/m²), and BMI values will then be converted to age- and sex-specific BMI-for-age z-scores using WHO reference standards. BMI-for-age z-scores are continuous measures with no fixed upper or lower limit. According to WHO criteria, children are classified as normal weight (\< +1 SD), overweight (≥ +1 SD), and obese (≥ +2 SD). Lower BMI-for-age z-scores indicate lower relative weight status, whereas higher BMI-for-age z-scores indicate greater relative weight status.

    Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up

  • Child Waist Circumference (cm)

    Child waist circumference will be assessed in centimeters using a non-elastic measuring tape. Measurements will be taken at the midpoint between the lowest rib and the iliac crest, with the child standing and measured at the end of normal expiration. Values will be recorded to the nearest 0.1 cm following standardized anthropometric measurement procedures. Waist circumference is a continuous measure with no fixed upper or lower limit. Lower waist circumference values indicate lower central adiposity, whereas higher values indicate greater central adiposity.

    Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up

Secondary Outcomes (8)

  • Brief Parental Self-Efficacy Scale (BPSES) Total Score

    Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up

  • Parental Role Modeling of Physical Activity Scale Total Score

    Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up

  • Parental Modeling of Eating Behavior Scale (PARM) Total Score

    Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up

  • Revised Family Communication Pattern Instrument (RFCP) Total Score

    Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up

  • Parental Stress Scale (PSS) Total Score

    Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up

  • +3 more secondary outcomes

Other Outcomes (3)

  • Percentage of Participants Completing All Study Assessments

    Throughout the study period (Baseline to 3-month follow-up)

  • Percentage of Assigned Program Activities Completed

    During the 8-week intervention period

  • Percentage of Participants Completing at Least 75% of Program Modules

    During the 8-week intervention period

Study Arms (2)

Web-Based Parental Role Modeling Program

EXPERIMENTAL

Parents in this group received the web-based parental role modeling program in addition to usual school health information. The program was delivered through a Learning Management System and was designed to help parents support healthy eating, physical activity, reduced screen time, and healthy family routines for children with overweight or obesity.

Behavioral: Web-based parental role modeling program

Standard Health Education Materials

ACTIVE COMPARATOR

Parents in this group received standard printed health education materials about healthy eating, physical activity, screen-time reduction, and healthy lifestyle practices for children with overweight or obesity. They did not receive access to the web-based program during the study period.

Behavioral: Standard health education materials

Interventions

Printed health education materials covering healthy nutrition, physical activity, reduced screen time, and healthy family lifestyle practices.

Also known as: Printed health education materials
Standard Health Education Materials

A culturally adapted online family health education program delivered through a Learning Management System. The program included six modules delivered over 8 weeks, with videos, presentations, quizzes, practical family activities, downloadable materials, self-monitoring tasks, reminders, and support through LMS and Zalo. Booster support was provided during the follow-up period.

Also known as: Parent-mediated intervention program
Web-Based Parental Role Modeling Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents of children aged 7-9 years with a BMI-for-age z-score ≥ +1 standard deviation (SD) according to the World Health Organization growth reference.
  • Willingness to participate in a web-based program, including attending online workshops and completing behavioral tasks and assessment.
  • Availability of the internet and digital devices necessary to engage in the web-based program.
  • Parents who were responsible for the child's daily health-related routines, including meals, physical activity, and screen-time management.

You may not qualify if:

  • Children with chronic medical conditions, physical disabilities, or developmental disorders that significantly affect dietary or physical activity behaviors or growth.
  • Parents who are unable to commit to the study timeline or program schedule.
  • Families already participating in another obesity-related program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hai Phong Medical University

Haiphong, Hai Phong, 180000, Vietnam

Location

MeSH Terms

Conditions

Pediatric ObesityOverweight

Condition Hierarchy (Ancestors)

ObesityOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Moonkyoung Park, PhD

    College of Nursing, Chungnam National University

    STUDY CHAIR
  • Do Thi Thu Huyen, MSN

    College of Nursing, Chungnam National University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study used a non-randomized parallel-group design. Participants were allocated to either an intervention group receiving a web-based parental role modeling program or a comparison group receiving standard health education materials. Outcomes were assessed at baseline, immediately after the 8-week intervention, 1 month after intervention, and 3 months after intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 11, 2026

Study Start

August 5, 2025

Primary Completion

February 1, 2026

Study Completion

February 18, 2026

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Beginning 6 months after publication of the primary study results and continuing for up to 5 years following publication.
Access Criteria
De-identified individual participant data, study protocol, statistical analysis plan, informed consent form, and analytic code will be available to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the study investigators and approved if consistent with the study objectives, ethical requirements, and participant confidentiality protections. Approved researchers will receive access to the requested materials through secure electronic transfer.

Locations