CClinicalTrials.gg
RecruitingNCT07458009Updated Apr 30, 2026

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

An interventional study of A 4-week theory-based online intervention targeting parental support in Preschool Children's Health Behaviors and Parental Support, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Feb 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 sugar-sweetened beverages, and washing their hands regularly.

The main questions this study aims to answer are:

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.

02

Conditions studied

  • Preschool Children's Health Behaviors
  • Parental Support

Keywords

  • parental support
  • integrated social cognitive theory
  • preschool children health behavior
03

In context

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    4-week multiple behavior change online intervention group

    Participants in intervention group will receive a 4-week online intervention

    Behavioral: A 4-week theory-based online intervention targeting parental support

  • No intervention
    Waitlist control group

    Participants in waitlist control group will receive the same intervention when the study is over

Interventions

  • BehavioralA 4-week theory-based online intervention targeting parental support

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

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

Secondary outcomes

  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).

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

07

Study locations

1 of 1 sites recruiting
  • Department of Psychology, Sun Yat-Sen University
    Guangzhou, Guangdong 510006, China
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No — IPD will not be shared due to privacy and confidentiality considerations, particularly given that the study involves parents and young children.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07458009
Lead sponsor
Sun Yat-sen University
Responsible party
Chun-Qing Zhang (Associate Professor, Sun Yat-sen University) — Principal investigator
First posted
Mar 9, 2026
Start date
Feb 28, 2026
Primary completion
Apr 28, 2026 (estimated)
Completion
Apr 28, 2026 (estimated)
Last update
Apr 30, 2026

Study contacts

Nuoyan Lu
Contact
luny3@mail2.sysu.edu.cn
+8618088834525
Chun-Qing Zhang
Contact
zhangchq28@mail.sysu.edu.cn

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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