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Childhood ObesityNCT07641452

Development and Evaluation of a Web-based Parental Role Modeling Program for Childhood Obesity Management

A study testing Web-based parental role modeling program and Standard health education materials in people with Childhood Obesity and Overweight and Obese Children, run by Do Thi Thu Huyen at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Web-based parental role modeling program and Standard health education materials
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteVietnam
Study dates
5 Aug 2025to 18 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site
  • Hai Phong Medical University

    Haiphong, Hai Phong, 180000

Other trials in Vietnam

About this study

Official title: Development and Evaluation of a Culturally Adapted Web-based Parental Role Modeling Program for Obesity Management in Vietnamese Primary-school Children

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:

Read more
  1. Does the program improve parents' confidence, role modeling behaviors, family communication, and healthy family practices?
  2. Does the program improve children's eating habits, physical activity, screen time, and body measurements related to overweight and obesity?

Researchers will compare the online family health education program with standard health education materials to see whether the program leads to greater improvements in children and their families.

Participants will:

  1. Complete surveys about their family's health habits and daily routines.
  2. Attend health checkups that include measurements of height, weight, and waist size.
  3. Receive either the online family health education program or standard health education materials.
  4. Complete follow-up assessments after the program and four months later.

The results of this study may help identify effective ways to support families in managing childhood overweight and obesity in Vietnam.

Read the detailed description

Childhood overweight and obesity have become increasingly prevalent in Vietnam and represent an important public health challenge. Children aged 7-9 years are at a developmental stage in which lifestyle habits, including dietary patterns, physical activity, and screen-related behaviors, are becoming established. At the same time, children remain strongly influenced by parental guidance and behavioral modeling. Parents therefore represent a key target for interventions designed to improve obesity-related behaviors and health outcomes among school-age children.

This study was conducted to develop and preliminarily evaluate a culturally adapted web-based parental role modeling program for parents of Vietnamese children aged 7-9 years with overweight or obesity. The intervention was designed to strengthen parental capacity to support healthy lifestyle behaviors within the family environment through education, behavioral practice, and ongoing digital support. The program was guided primarily by Social Cognitive Theory, which emphasizes observational learning, role modeling, reinforcement, and self-efficacy as mechanisms of behavior change. Bowen's concept of differentiation of self was incorporated into selected intervention activities to support parental emotional regulation, effective communication, consistent rule-setting, and maintenance of healthy family routines.

The study was conducted in two phases.

  1. Phase 1: Development of the Web-Based Parental Role Modeling Program The intervention was developed using the ADDIE instructional design framework, consisting of Analysis, Design, and Development phases. During the analysis phase, a comprehensive literature review was conducted to identify evidence-based strategies related to childhood obesity management, parental role modeling, family-based behavioral interventions, and web-based health education. In addition, semi-structured interviews were conducted with 10 parents of children aged 7-9 years with overweight or obesity to explore educational needs, barriers to healthy lifestyle practices, family routines, caregiving challenges, and preferences for digital learning. Findings from the literature review and needs assessment were used to determine intervention priorities, learning objectives, educational content, and delivery strategies. During the design phase, a theory-based intervention framework was established. Program objectives, educational strategies, module sequencing, learning activities, and digital delivery methods were developed. The intervention consisted of six educational modules delivered over an 8-week period, followed by a 4-month maintenance and observation phase. Module content addressed childhood overweight and obesity, healthy nutrition, physical activity promotion, reduction of sedentary behaviors and recreational screen time, parental role modeling, family communication, family routines, and maintenance of long-term behavior change. During the development phase, educational materials and the Learning Management System (LMS) were created. Program materials included educational videos, presentations, quizzes, practical family activities, posters, visual reminders, and downloadable learning resources. Expert review was conducted to assess content validity, cultural appropriateness, practical applicability, and theoretical alignment. Prototype testing and usability testing were subsequently conducted with parents and experts, and revisions were made before implementation.
  2. Phase 2: Feasibility and Preliminary Evaluation The evaluation phase employed an explanatory sequential mixed-methods design consisting of a quantitative quasi-experimental study followed by qualitative exit interviews. The quantitative component used a non-equivalent control group pretest-posttest design. Participants were recruited from five elementary schools in Hai Phong, Vietnam. Eligible participants were parents or primary caregivers of children aged 7-9 years with a BMI-for-age z-score ≥ +1 SD according to the World Health Organization growth reference. Parents were required to have access to the internet and digital devices and to be responsible for the child's daily routines related to eating, physical activity, and screen use. Children with chronic medical conditions, physical disabilities, developmental disorders affecting growth or lifestyle behaviors, families already participating in obesity-related programs, and parents unable to commit to the study schedule were excluded. Because randomization was not feasible, schools were allocated to either the intervention or control condition prior to participant recruitment to minimize contamination between groups. Parents recruited from intervention schools received the web-based parental role modeling program, whereas parents recruited from control schools received standard printed health education materials. A total of 60 parents were enrolled, with 30 allocated to the intervention group and 30 allocated to the control group. One participant withdrew from the intervention group during the study, resulting in a final sample of 59 participants.
  • Intervention Procedures Participants in the intervention group attended an online orientation session before beginning the program. During this session, parents received instructions on accessing the LMS, completing learning modules, participating in quizzes and activities, monitoring progress, and using the Zalo platform for communication and support. Parents then completed six web-based educational modules over an 8-week intervention period. Educational content was delivered through videos, presentations, quizzes, self-monitoring activities, and practical family-based exercises. Reminders and notifications were delivered through both the LMS and Zalo to encourage participation and adherence. Parents were also able to communicate with the research team through discussion forums and messaging functions. During the subsequent 4-month follow-up period, booster support activities were provided to reinforce learning and support maintenance of behavior change. These booster activities included online workshops, webinars, posters, infographics, and visual educational materials focusing on healthy nutrition, physical activity, family routines, and parental role modeling. Participants in the control group received printed educational materials related to healthy lifestyle practices but did not receive access to the LMS, online modules, or booster activities. Outcome Assessments: Data were collected at four time points:
  • Baseline before intervention (T0)
  • Immediately after completion of the 8-week intervention (T1)
  • One-month follow-up (T2)
  • Three-month follow-up (T3)
  • The primary focus of evaluation was feasibility. Primary feasibility outcomes included recruitment rate, retention rate, module completion rate, adherence to intervention activities, data completeness, usability, acceptability, participant satisfaction, perceived burden, and intervention-related adverse events. Predefined feasibility criteria were established before study implementation.
  • Secondary and exploratory outcomes included both parent-level and child-level outcomes. Parent-level outcomes included:
  • Parental self-efficacy
  • Parental role modeling of healthy eating
  • Parental role modeling of physical activity
  • Family communication patterns
  • Parental stress Child-level outcomes included:
  • Fruit and vegetable consumption
  • Physical activity behaviors
  • Recreational screen-time behaviors
  • BMI-for-age z-score
  • Waist circumference Anthropometric assessments were conducted by trained research personnel using standardized procedures. Height, weight, and waist circumference measurements were obtained at Hai Phong University of Medicine and Pharmacy Hospital. BMI-for-age z-scores were calculated using WHO growth references for children aged 5-19 years.
  • Qualitative Evaluation Following completion of the quantitative phase, purposive sampling was used to recruit intervention participants for individual semi-structured exit interviews. Interviews explored participant experiences with the LMS platform, perceived usefulness of program content, changes in parenting practices and family routines, barriers and facilitators to participation, satisfaction with the intervention, and recommendations for future improvement. Interviews were conducted face-to-face, audio-recorded with participant consent, and lasted approximately 30-45 minutes. Qualitative data were analyzed using thematic analysis. Findings from the qualitative phase were integrated with quantitative findings during interpretation to provide a more comprehensive understanding of intervention feasibility, acceptability, implementation processes, and potential mechanisms of behavior change. This study was designed to determine whether a culturally adapted web-based parental role modeling intervention is feasible, acceptable, and potentially effective for supporting healthy lifestyle behaviors and obesity management among Vietnamese primary-school children with overweight or obesity. Findings will inform the design of future large-scale randomized controlled trials and the development of scalable family-based childhood obesity interventions in Vietnam.
Being tested
Web-based parental role modeling program, Standard health education materials
Keywords
childhood obesity, family-centered intervention, self-efficacy, role modeling, mixed-methods, parent-mediated intervention, Vietnam
Medical subject headings
Pediatric Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web-based parental role modeling programBehavioural

    Also called Parent-mediated intervention program

    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.

  • Standard health education materialsBehavioural

    Also called Printed health education materials

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

Study groups in NCT07641452
Study groupRoleWhat they receive
Web-Based Parental Role Modeling ProgramExperimentalParents 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.
Receives: Behavioral: Web-based parental role modeling program
Standard Health Education MaterialsActive comparatorParents 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.
Receives: Behavioral: Standard health education materials

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (8)
  1. Brief Parental Self-Efficacy Scale (BPSES) Total Score

    Parental self-efficacy will be assessed using the Brief Parental Self-Efficacy Scale (BPSES), a 5-item questionnaire rated on a 5-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree). Total scores range from 5 to 25, with higher scores indicating greater parental confidence in implementing healthy lifestyle behaviors for their child.

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

  2. Parental Role Modeling of Physical Activity Scale Total Score

    Parental role modeling of physical activity will be assessed using the Parental Role Modeling of Physical Activity Scale. The scale contains 8 items scored from 0 (Never) to 4 (Always). Total scores range from 0 to 32, with higher scores indicating greater parental modeling of physical activity behaviors.

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

  3. Parental Modeling of Eating Behavior Scale (PARM) Total Score

    Eating-related parental role modeling will be assessed using the Parental Modeling of Eating Behavior Scale (PARM), a 15-item questionnaire rated on a 5-point Likert scale from 1 (Never) to 5 (Always). A total score will be calculated by summing all items (range: 15-75), with higher total scores indicate greater parental modeling of healthy eating-related behaviors.

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

  4. Revised Family Communication Pattern Instrument (RFCP) Total Score

    Family communication patterns will be assessed using the parent version of the Revised Family Communication Pattern Instrument (RFCP), a 26-item questionnaire rated on a 5-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree). Total scores range from 26 to 130, with higher scores indicating stronger family communication and engagement within the family.

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

  5. Parental Stress Scale (PSS) Total Score

    Parental stress will be assessed using the Parental Stress Scale (PSS), an 18-item questionnaire scored on a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree). Total scores range from 18 to 90, with higher scores indicating greater perceived parental stress and lower scores indicating lower levels of parenting-related stress.

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

  6. Parent-Reported Mean Daily Fruit and Vegetable Intake (Servings per Day)

    Child fruit and vegetable intake will be assessed using parent-completed weekly behavioral logs. Parents will record the number of fruit and vegetable servings consumed by the child each day. Mean daily fruit and vegetable intake will be calculated as the average number of servings consumed per day during each assessment period. Higher values indicate greater fruit and vegetable consumption and healthier dietary behavior.

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

  7. Parent-Reported Proportion of Days Achieving at Least 60 Minutes of Physical Activity (%)

    Child physical activity will be assessed using parent-completed weekly behavioral logs. The outcome will be calculated as the percentage of recorded days during which the child achieves at least 60 minutes of physical activity. Values range from 0% to 100%, with higher percentages indicating greater adherence to recommended physical activity guidelines.

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

  8. Parent-Reported Proportion of Days With Recreational Screen Time Less Than 2 Hours (%)

    Child screen-time behavior will be assessed using parent-completed weekly behavioral logs. The outcome will be calculated as the percentage of recorded days during which the child's recreational screen time is less than 2 hours per day. Values range from 0% to 100%, with higher percentages indicating healthier screen-time behavior and better adherence to recommended screen-time guidelines.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2026
  2. Study start5 Aug 2025
  3. Primary completion1 Feb 2026
  4. Study completion18 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07641452
Sponsor's protocol ID
17/C/A-IRB
Status last verified
Jun 2026
First submitted
2 Jun 2026
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Web-based parental role modeling program and Standard health education materials in people with Childhood Obesity and Overweight and Obese Children, run by Do Thi Thu Huyen at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child Body Mass Index-for-Age z-Score (BMI-for-Age z-Score) (time frame: Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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