- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07641452
Development and Evaluation of a Web-based Parent Program for Childhood Obesity Management
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:
- Does the program improve parents' confidence, role modeling behaviors, family communication, and healthy family practices?
- 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:
- Complete surveys about their family's health habits and daily routines.
- Attend health checkups that include measurements of height, weight, and waist size.
- Receive either the online family health education program or standard health education materials.
- 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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
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.
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Hai Phong
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Haiphong, Hai Phong, Wietnam, 180000
- Hai Phong Medical University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Web-Based Parental Role Modeling Program
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.
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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.
Inne nazwy:
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Aktywny komparator: Standard Health Education Materials
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.
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Printed health education materials covering healthy nutrition, physical activity, reduced screen time, and healthy family lifestyle practices.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Child Body Mass Index-for-Age z-Score (BMI-for-Age z-Score)
Ramy czasowe: Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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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.
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Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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Child Waist Circumference (cm)
Ramy czasowe: Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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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.
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Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Brief Parental Self-Efficacy Scale (BPSES) Total Score
Ramy czasowe: Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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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.
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Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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Parental Role Modeling of Physical Activity Scale Total Score
Ramy czasowe: Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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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.
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Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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Parental Modeling of Eating Behavior Scale (PARM) Total Score
Ramy czasowe: Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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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.
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Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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Revised Family Communication Pattern Instrument (RFCP) Total Score
Ramy czasowe: Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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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.
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Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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Parental Stress Scale (PSS) Total Score
Ramy czasowe: Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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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.
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Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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Parent-Reported Mean Daily Fruit and Vegetable Intake (Servings per Day)
Ramy czasowe: Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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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.
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Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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Parent-Reported Proportion of Days Achieving at Least 60 Minutes of Physical Activity (%)
Ramy czasowe: Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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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.
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Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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Parent-Reported Proportion of Days With Recreational Screen Time Less Than 2 Hours (%)
Ramy czasowe: Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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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.
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Baseline, post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percentage of Participants Completing All Study Assessments
Ramy czasowe: Throughout the study period (Baseline to 3-month follow-up)
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Participant retention will be assessed as the percentage of enrolled participants who complete all study assessments through the study period (%).
Higher percentages indicate greater participant retention and feasibility.
The program will be considered feasible if at least 80% of enrolled participants complete the final assessment.
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Throughout the study period (Baseline to 3-month follow-up)
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Percentage of Assigned Program Activities Completed
Ramy czasowe: During the 8-week intervention period
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Program adherence will be assessed as the percentage of assigned intervention activities completed by participants during the intervention period (%).
Higher percentages indicate greater adherence to the intervention.
The intervention will be considered feasible if average adherence is at least 70%.
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During the 8-week intervention period
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Percentage of Participants Completing at Least 75% of Program Modules
Ramy czasowe: During the 8-week intervention period
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Module completion will be assessed as the percentage of intervention participants who complete at least 75% of the educational modules delivered through the Learning Management System (LMS).
Higher percentages indicate greater program engagement and feasibility.
The intervention will be considered feasible if at least 70% of participants complete 75% or more of the program modules.
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During the 8-week intervention period
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Krzesło do nauki: Moonkyoung Park, PhD, College of Nursing, Chungnam National University
- Główny śledczy: Do Thi Thu Huyen, MSN, College of Nursing, Chungnam National University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 17/C/A-IRB
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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