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.
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
- Conditions the study is for
- Preschool Children's Health Behaviors, Parental Support
- What is being tested?
- A 4-week theory-based online intervention targeting parental support
- Type of treatment
- Lifestyle or therapy programme
- 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.
Chun-Qing Zhang contact
China1 site, 1 recruiting
- Recruiting
Department of Psychology, Sun Yat-Sen University
Guangzhou, Guangdong, 510006
Fan Mo, +86 020-39335843, mofan26@mail.sysu.edu.cn
Nuoyan Lu
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:
- 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.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| 4-week multiple behavior change online intervention group | Experimental | Participants in intervention group will receive a 4-week online intervention Receives: Behavioral: A 4-week theory-based online intervention targeting parental support |
| Waitlist control group | No intervention | Participants 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.
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
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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.
- First posted9 Mar 2026
- Study start28 Feb 2026
- Primary completion28 Apr 2026 (estimated)
- Study completion28 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preschool Children's Health BehaviorsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun-Qing Zhang, Sun Yat-sen University
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Theory-Based Intervention to Improve Parental Support for Preschool Children's Health Behaviors
- ClinicalTrials.gov ID
- NCT07458009
- Acronym / sponsor ID
- 202601200451
- Keywords
- parental support, integrated social cognitive theory, preschool children health behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 28 Apr 2026 (estimated)
- Study completion
- 28 Apr 2026 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-week multiple behavior change online intervention group | Experimental | Behavioral: A 4-week theory-based online intervention targeting parental supportParticipants in intervention group will receive a 4-week online intervention |
| Waitlist control group | No intervention | –Participants in waitlist control group will receive the same intervention when the study is over |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A 4-week theory-based online intervention targeting parental supportThe 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. | Behavioural | 4-week multiple behavior change online intervention group |
Primary outcome
Mean score on the Parental Support for Child Physical Activity Scale
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
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.
Mean score on the Parental Support for Child Screen Time Reduction Scale
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
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.
Mean score on the Parental Support for Child Handwashing Scale
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
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.
Mean score on the Parental Support for Sugar-Sweetened Beverage Reduction Scale
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
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.
Average daily outdoor physical activity time of the child (hours/day)
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
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.
Average daily child screen time (hours/day)
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
Parent-reported average daily time the child spends using screens (television, computers, tablets, mobile phones, or video games).
Mean score on the Child Handwashing Behavior Scale
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
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.
Frequency of child sugar-sweetened beverage consumption
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
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.
10 secondary outcomes
Parental Attitude Toward Supporting Child Health Behaviors
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
Subjective Norm Toward Supporting Child Health Behaviors
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
Parental Self-Efficacy for Supporting Child Health Behaviors
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
Perceived Social Norm Supporting Child Health Behaviors
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
Social Support for Parental Support Behaviors
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
Behavioral Intention to Support Child Health Behaviors
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
Action Planning for Supporting Child Health Behaviors
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
Coping Planning for Supporting Child Health Behaviors
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
Action Control for Supporting Child Health Behaviors
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
Behavioral Automaticity of Parental Support
Time frame: Baseline, post-intervention (4 weeks), and 1-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 34996794Kokai 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.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy and confidentiality considerations, particularly given that the study involves parents and young children.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chun-Qing Zhang contact
1 site in 1 country: see every site and its status.
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.