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Preschool Children's Health BehaviorsNCT07458009

Theory-Based Parenting Intervention for Preschool Children's Health Behaviors

A study testing A 4-week theory-based online intervention targeting parental support in people with Preschool Children's Health Behaviors and Parental Support, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this study is to test whether a 4-week online program can help parents better support health behaviors of their preschool children (aged 3-6 years). Preschool children often rely on their parents to build health behaviors, such as being physically active, limiting screen time, drinking fewer… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
A 4-week theory-based online intervention targeting parental support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
28 Feb 2026to 28 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Parent of at least one child aged 3-6 years
  • Living in the same household as the child
  • Aged 18 years or older
  • Able to read and understand Chinese
  • Willing to participate in a 4-week online intervention program

Who cannot join

  • Self-reported diagnosis of a severe psychiatric disorder that may interfere with participation
  • Cognitive impairment or language difficulties that prevent comprehension of study materials or completion of questionnaires
  • Currently participating in another structured parenting or health behavior intervention program

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Department of Psychology, Sun Yat-Sen University

    Guangzhou, Guangdong, 510006

    Fan Mo, +86 020-39335843, mofan26@mail.sysu.edu.cn

    Nuoyan Lu

    Recruiting

Other trials in China

About this study

Official title: A Randomized Controlled Trial of a Theory-Based Intervention to Improve Parental Support for Preschool Children's Health Behaviors

The goal of this study is to test whether a 4-week online program can help parents better support health behaviors of their preschool children (aged 3-6 years). Preschool children often rely on their parents to build health behaviors, such as being physically active, limiting screen time, drinking fewer sugar-sweetened beverages, and washing their hands regularly.

The main questions this study aims to answer are:

Read more

Does the program improve parents' motivation, planning, and habits related to supporting their children's health behaviors? Do parents who receive the program provide more support for their children? Do preschool children in the program show improvements in health behaviors? Can improvements explained by changes in parents' psychological factors?

Researchers will compare parents who receive the program immediately to parents in a waitlist control group.

Participants will:

Complete online questionnaires before the program, after the program, and one month later (Intervention group only). Complete eight online sessions over four weeks using a mobile program.

Read the detailed description

Background Early childhood is a critical developmental period for establishing long-term health habits. Preschool children have limited capacity for self-regulation and depend heavily on parental guidance to adopt and maintain health behaviors. Therefore, interventions targeting parents may be particularly effective in promoting child health behaviors during this stage.

Previous research has primarily focused on motivational and self-regulatory determinants of parental support behaviors. However, intention-based models often fail to account for automatic processes, such as habit formation, which may contribute to the intention-behavior gap. To address this limitation, the present study integrates motivational, volitional, and automatic processes into a integrated social cognitive framework to better explain parental decision-making in supporting children's health behaviors.

Study Objectives and Hypotheses The primary objective is to evaluate the effectiveness of a 4-week theory-based intervention targeting parental psychological determinants and behavioral outcomes.

It is hypothesized that:

  1. Parents in the intervention group will demonstrate greater improvements in motivational variables (e.g., attitudes, perceived norms, self-efficacy), volitional variables (e.g., action planning, coping planning, action control), and habit compared to the waitlist control group.
  2. Parents in the intervention group will report greater increases in supporting behaviors, and their children will show greater improvements in health behaviors compared to the waitlist control group.
  3. Changes in motivational, volitional, and automatic variables will mediate the relationship between group assignment and behavioral outcomes.

Study Design This study employs a longitudinal two-arm randomized controlled trial design. Participants are randomly assigned to either an intervention group or a waitlist control group.

Assessments are conducted at baseline (T1), post-intervention (T2), and one-month follow-up (T3). The intervention group also provides feedback regarding program experience.

The intervention targets multiple child health behaviors, including physical activity, screen time, sugar-sweetened beverage consumption, and handwashing.

Intervention Overview The intervention consists of eight sessions delivered over four weeks via a mobile program. Each session lasts approximately 20-30 minutes and includes multimedia materials and interactive exercises.

Weeks 1-2 focus on motivational processes (attitudes, perceived norms, self-efficacy, and social support).

Week 3 focuses on volitional processes (action planning, coping planning, and action control).

Week 4 focuses on habit formation, cue-based strategies, and multiple health behaviors.

Behavior change techniques include goal setting, action planning, self-monitoring, prompts/cues, modeling, Information about health consequences, social support and reward.

Statistical Analysis Plan Intervention effects will be examined using 2 (group) × 3 (time) repeated-measures analyses of variance. Significant interaction effects will be followed by simple effects analyses.

To examine mediation, social cognitive variables will be tested as mediators. Group assignment (intervention = 1, control = 0) will serve as the independent variable, and parental support and child health behaviors will serve as dependent variables. Separate mediation analyses will be conducted for each mediator.

Being tested
A 4-week theory-based online intervention targeting parental support
Keywords
parental support, integrated social cognitive theory, preschool children health behavior

What participants receive

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

  • A 4-week theory-based online intervention targeting parental supportBehavioural

    The intervention consists of eight sessions delivered over four weeks via a mobile program. Each session lasts approximately 20-30 minutes and includes multimedia materials and interactive exercises.

Study groups in NCT07458009
Study groupRoleWhat they receive
4-week multiple behavior change online intervention groupExperimentalParticipants in intervention group will receive a 4-week online intervention
Receives: Behavioral: A 4-week theory-based online intervention targeting parental support
Waitlist control groupNo interventionParticipants in waitlist control group will receive the same intervention when the study is over

What is being measured

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

  1. Mean score on the Parental Support for Child Physical Activity Scale

    Parental support for child physical activity will be assessed using a 3-item parent-reported questionnaire. Each item is rated on a 5-point Likert scale. The total score is calculated as the mean of the three items, with higher scores indicating greater parental support for child physical activity.

    Items assess encouragement of outdoor play, co-participation in physical activity, and providing transportation for physical activity.

    Measured: Baseline, post-intervention (4 weeks), and 1-month follow-up

  2. Mean score on the Parental Support for Child Screen Time Reduction Scale

    Assessed using a 2-item parent-reported questionnaire rated on a 7-point Likert scale. The outcome is calculated as the mean score across items, with higher scores indicating greater parental support for reducing child screen time.

    Items assess encouraging children to stop screen use and reminding children to follow screen-time rules.

    Measured: Baseline, post-intervention (4 weeks), and 1-month follow-up

  3. Mean score on the Parental Support for Child Handwashing Scale

    Measured using a 3-item parent-reported questionnaire rated on a 7-point Likert scale. The outcome is the mean item score, with higher scores indicating greater parental support for child handwashing.

    Items assess teaching proper handwashing methods, reminders before meals and after toilet use, and parental modeling of handwashing behavior.

    Measured: Baseline, post-intervention (4 weeks), and 1-month follow-up

  4. Mean score on the Parental Support for Sugar-Sweetened Beverage Reduction Scale

    Measured using a 4-item parent-reported questionnaire rated on a 7-point Likert scale. The outcome is calculated as the mean score across items, with higher scores indicating greater parental support for reducing children's sugar-sweetened beverage intake.

    Items assess limiting beverage intake, encouraging healthier alternatives, discussing health consequences, and parental role modeling.

    Measured: Baseline, post-intervention (4 weeks), and 1-month follow-up

  5. Average daily outdoor physical activity time of the child (hours/day)

    Parent-reported child outdoor physical activity time assessed separately for weekdays and weekends over the past two weeks. Average daily physical activity is calculated as:

    (5 × weekday activity hours + 2 × weekend activity hours) / 7. Higher values indicate greater physical activity.

    Measured: Baseline, post-intervention (4 weeks), and 1-month follow-up

  6. Average daily child screen time (hours/day)

    Parent-reported average daily time the child spends using screens (television, computers, tablets, mobile phones, or video games).

    Measured: Baseline, post-intervention (4 weeks), and 1-month follow-up

  7. Mean score on the Child Handwashing Behavior Scale

    Measured using a 3-item parent-reported questionnaire rated on a 7-point Likert scale. The mean score across items is calculated, with higher scores indicating more frequent handwashing behavior.

    Items assess handwashing after returning home, before meals, and adherence to recommended handwashing procedures.

    Measured: Baseline, post-intervention (4 weeks), and 1-month follow-up

  8. Frequency of child sugar-sweetened beverage consumption

    Parent-reported frequency of child consumption of sugar-sweetened beverages (excluding 100% fruit juice), rated on a 6-point scale ranging from 1 (none) to 6 (three or more times per week). Higher scores indicate greater consumption frequency.

    Measured: Baseline, post-intervention (4 weeks), and 1-month follow-up

Secondary outcomes (10)
  1. Parental Attitude Toward Supporting Child Health Behaviors

    Parental attitude will be assessed using a self-report questionnaire consisting of 4 items evaluating parents' positive or negative evaluations of supporting their child's health behaviors.

    Items are rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree).

    Measured: Baseline, post-intervention (4 weeks), and 1-month follow-up

  2. Subjective Norm Toward Supporting Child Health Behaviors

    Subjective norm will be measured using a self-report scale assessing perceived social pressure from important others to support children's health behaviors.

    Items are rated on a 7-point Likert scale (1-7)

    Measured: Baseline, post-intervention (4 weeks), and 1-month follow-up

  3. Parental Self-Efficacy for Supporting Child Health Behaviors

    Self-efficacy will be assessed using a 2-item self-report questionnaire measuring parents' confidence in supporting their child's healthy behaviors under various situations.Items are rated on a 7-point Likert scale

    Measured: Baseline, post-intervention (4 weeks), and 1-month follow-up

  4. Perceived Social Norm Supporting Child Health Behaviors

    Perceived social norm reflects parents' perceptions of common practices among peers regarding supporting children's health behaviors.Items are rated on a 7-point Likert scale and averaged.Higher scores indicate stronger perceived normative support

    Measured: Baseline, post-intervention (4 weeks), and 1-month follow-up

  5. Social Support for Parental Support Behaviors

    Social support will be measured using a self-report scale assessing emotional and practical support received from family members or others. Items are rated on a 7-point Likert scale.

    Measured: Baseline, post-intervention (4 weeks), and 1-month follow-up

  6. Behavioral Intention to Support Child Health Behaviors

    Behavioral intention will be assessed using items measuring parents' intention to engage in supportive health behavior practices (each of the four health behavior includes 1 item). Items are rated on a 7-point Likert scale.

    Measured: Baseline, post-intervention (4 weeks), and 1-month follow-up

  7. Action Planning for Supporting Child Health Behaviors

    Action planning assesses the extent to which parents formulate specific plans regarding when, where, and how to support child health behaviors. Items are rated on a 7-point Likert scale and averaged.

    Measured: Baseline, post-intervention (4 weeks), and 1-month follow-up

  8. Coping Planning for Supporting Child Health Behaviors

    Coping planning evaluates parents' preparation for managing barriers to supporting child health behaviors. Items are rated on a 7-point Likert scale.

    Measured: Baseline, post-intervention (4 weeks), and 1-month follow-up

  9. Action Control for Supporting Child Health Behaviors

    Action control reflects self-monitoring, awareness of behavioral standards, and regulatory effort during behavior implementation. Items are rated on a 7-point Likert scale.

    Measured: Baseline, post-intervention (4 weeks), and 1-month follow-up

  10. Behavioral Automaticity of Parental Support

    Automaticity will be measured using a self-report habit scale assessing the extent to which parental support behaviors are performed automatically with little conscious effort.

    Measured: Baseline, post-intervention (4 weeks), and 1-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 posted9 Mar 2026
  2. Study start28 Feb 2026
  3. Primary completion28 Apr 2026 (estimated)
  4. Study completion28 Apr 2026 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07458009
Sponsor's protocol ID
202601200451
Status last verified
Mar 2026
First submitted
23 Feb 2026
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared due to privacy and confidentiality considerations, particularly given that the study involves parents and young children.

Publications

  • Kokai LL, O Ceallaigh DT, Wijtzes AI, Roeters van Lennep JE, Hagger MS, Cawley J, Rohde KIM, van Kippersluis H, Burdorf A. Moving from intention to behaviour: a randomised controlled trial protocol for an app-based physical activity intervention (i2be). BMJ Open. 2022 Jan 7;12(1):e053711. doi: 10.1136/bmjopen-2021-053711.

    PubMed 34996794

Questions about this trial

What is this clinical trial studying?

A study testing A 4-week theory-based online intervention targeting parental support in people with Preschool Children's Health Behaviors and Parental Support, run by Sun Yat-sen University at 1 site in China.

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 5 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: looking for participants now, as of the sponsor's last update on 30 Apr 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 China. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Nuoyan Lu (+8618088834525, luny3@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean score on the Parental Support for Child Physical Activity Scale (time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07458009, which also lists 1 linked publication.

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 30 Apr 2026.

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