Effectiveness of Parent-based Electronic Health (eHealth) Intervention on Preschoolers' Physical Activity, Dietary Behaviors, and Sleep Problems

NCT ID: NCT06025019

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

512 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Lifestyle Physical Activity Dietary Behaviors Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Electronic Health (eHealth)

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.

Group Type EXPERIMENTAL

parent-based Electronic Health intervention

Intervention Type BEHAVIORAL

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).

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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parent-based Electronic Health intervention

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Parental commitment to participate in the overall 6-month intervention.
3. Parents have access to mobile technology.
4. 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.
5. 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).

Exclusion Criteria

1. 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).
2. 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.
3. 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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Normal University

OTHER

Sponsor Role collaborator

Hong Kong Baptist University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Lau Wing Chung, Ph.D

Role: CONTACT

References

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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.

Reference Type DERIVED
PMID: 40896827 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39776485 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39264108 (View on PubMed)

Other Identifiers

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HKBU21481504ZP

Identifier Type: -

Identifier Source: org_study_id

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