NCT06025019

Brief Summary

Background: Preschoolers' lifestyles have become physically inactive and sedentary, their eating habits unhealthy, and their sleep routines increasingly disturbed. Parental involvement appears to be crucial to combat unhealthy lifestyle of preschoolers. Because of recognized barriers of traditional face-to-face interventions (such as time commitment for parents), easy access and lower costs make electronic health (eHealth) interventions appealing. Previous studies that examined the effectiveness of parent-based eHealth on preschooler's (physical activity) PA, dietary behaviors (DB), and sleep have either emphasized on one variable or failed to balance the dosage of PA, diet, and sleep modules or consider the intervention sequence during the intervention period and there is an acknowledged gap in parent-based eHealth interventions which target preschoolers raised in Chinese cultural contexts. Objective: This study aims to investigate the effectiveness of parent-based eHealth intervention on Chinese preschoolers' PA, DB, and sleep problems. Methods: This two-arm parallel randomized controlled trial comprises a 12-week intervention with a 12-week follow-up. 206 parent-child dyads will be randomized to either eHealth intervention group or control group. Participants allocated to the eHealth intervention will receive 12 interactive modules on PA, DB, and sleep, with each module rot on a weekly basis to reduce the sequence effect on variable outcomes. The intervention is grounded upon Social Cognitive Theory and will be delivered through social media, where parents can obtain valid and updated educational information, social rapport, and interact with other group members and facilitators. Participants in the control group will receive weekly brochures on PA, DB, and sleep recommendations from the kindergarten teachers, but they will not receive any interactive components. Data will be collected at baseline, 3 months, and 6 months. The primary outcome will be the preschooler's physical activity. The secondary outcomes will be the preschooler's dietary behaviors, preschooler's sleep duration, and preschooler's sleep problems, parent's PA, parenting style, and parental feeding style. Significance of this study: The parent-based eHealth intervention has potential to overcome the aforementioned barriers of face-to-face interventions, which will offer a novel approach for promoting healthy lifestyle of preschoolers. If found to be efficacious, the prevalence of unhealthy lifestyles among preschoolers may be alleviated at a low cost, which not only has a positive influence on the health of the individual and the well-being of the family but also reduces the financial pressure on society to treat diseases caused by poor lifestyle habits.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
512

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

September 6, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

July 9, 2023

Last Update Submit

August 29, 2023

Conditions

Keywords

physical activitydietary behaviorssleepparent-based intervention

Outcome Measures

Primary Outcomes (1)

  • Change of preschoolers' physical activity

    Preschoolers' PA will be assessed baseline, at the end of 12-week post-intervention, and at the end of 12-week follow-up, using Garmin vivofit Jr 3 Fitness Tracker for Kids, which is a wrist-wear watch designed specifically for children from 4 to 9 years old to track PA in terms of steps and moderate-to-vigorous physical activity (MVPA) in minutes per day but not energy expenditure. This device has shown to be valid and accurate in assessing PA in preschoolers.

    Through study completion, 24 weeks

Secondary Outcomes (6)

  • Change of preschoolers' dietary behaviors

    Through study completion, 24 weeks

  • Change of preschoolers' sleep duration

    Through study completion, 24 weeks

  • Change of preschoolers' sleep problems

    Through study completion, 24 weeks

  • Change of parents' physical activity

    Through study completion, 24 weeks

  • Change of parenting style

    Through study completion, 24 weeks

  • +1 more secondary outcomes

Other Outcomes (1)

  • Demographic information

    Baseline

Study Arms (2)

Electronic Health (eHealth)

EXPERIMENTAL

Participants allocated to the eHealth intervention group will be delivered the evidence-based information and interactive components via social media (i.e., WeChat, similar to WhatsApp; and TikTok/Douyin, similar to YouTube). The interactive components include game, push notification, social rapport, influence agent, goal setting and personalized feedback.

Behavioral: parent-based Electronic Health intervention

Control group

NO INTERVENTION

Participants allocated to the control group will be delivered printed evidence-based educational materials on standard recommendations for PA, diet, and sleep, without interactive components.

Interventions

The eHealth intervention comprises 12 modules on three interaction modules related to physical activity, dietary behavior, and sleep. The intervention groups will be invited to a "WeChat group". A 3-minute video (made on the TikTok APP) will be sent to each WeChat group. Based upon the social media studies recommendation, five to nine members in a group will produce the desirable group interactive effect. Therefore, the present study allocates eight parents to one WeChat group. In total, there will be 26 groups (206 parents) according to the sample size calculation. Consistent with Social Cognitive THeory, the content of each module will follow the four steps: 1. Attention (Read educational material and watch TikTok/Douyin video (less than 3 minutes). 2.Retention (parental interaction). 3.Reproduction (Set goals and conduct behaviors). 4.Motivation (feedback and making changes).

Electronic Health (eHealth)

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parents are beyond 21 years old and have 4-6-year-old children. Selection of this child's age range was based on two factors. First of all, the age ranges from 4 to 6 have been found to be a strong predictor of future health. Secondly, a significant barrier to healthy DB is food neophobia, commonly known as picky or fussy eating, a reluctance, fear, or refusal to have new foods that is common in young children aged from 4 to 7.5 years.
  • Parental commitment to participate in the overall 6-month intervention.
  • Parents have access to mobile technology.
  • Parents and children must be healthy (refer to a state of physical, mental, social, intellectual, and emotional well-being and the absence of disease) and can participate in normal PA.
  • Parents must reside with participating child for at least four days a week (for the children to be adequately exposed to the intervention that parents may implement).

You may not qualify if:

  • if they meet the WHO criteria for preschool age children in terms of PA (i.e., 180 minutes of in a variety of PA at any intensity, of which 60 minutes is MVPA), sedentary behaviors (i.e., no more than 1 hour at a time being sedentary such as sit in car, no more than 1 hour per day in screen time such as TV, phone, and computer), DB (such as daily salt intake should be less than 5g), and sleep time (i.e., over 10 hours good quality sleep including nap, with regular sleep and wake time).
  • they diagnosed with neurological or physically disable and children who have a parent suffering from a serious physical or psychological disease making the study too demanding for the family will be excluded from the study.
  • if they have special dietary requirements or allergies that would necessitate the tailoring intervention or that may be adversely affected by the intervention. Eligible participants will be required to provide informed consent by completing a written consent form after reading the participant information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Peng Z, Wen LM, Lau PWC. Effectiveness of a Parent-Based eHealth Intervention on Physical Activity, Dietary Behaviors, and Sleep in Preschoolers: Randomized Controlled Trial. J Med Internet Res. 2025 Sep 2;27:e70886. doi: 10.2196/70886.

  • Peng Z, Lau PW, Wen LM. Moderating effects of demographic characteristics on the relationship between parenting practices and energy balance related behaviors of Chinese preschoolers. Front Public Health. 2024 Dec 24;12:1476733. doi: 10.3389/fpubh.2024.1476733. eCollection 2024.

  • Zhou P, Song H, Lau PWC, Shi L, Wang J. Effectiveness of a Parent-Based eHealth Intervention for Physical Activity, Dietary Behavior, and Sleep Among Preschoolers: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 12;13:e58344. doi: 10.2196/58344.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Lau Wing Chung, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study is a two parallel-group, single-blinded randomized controlled trial designed to promote preschoolers' PA, and DB, and reduce sleep problems by providing parents with relevant health information through the eHealth modality. The two arms comprise (1) eHealth intervention and (2) control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2023

First Posted

September 6, 2023

Study Start

September 1, 2023

Primary Completion

January 31, 2024

Study Completion

May 31, 2024

Last Updated

September 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share