Evaluation of Innovative School-based Interventions on Health Outcomes Among Primary School Students During Post COVID-19 Pandemic

NCT06766890 | Active Not Recruiting

• 1 other identifier: CV-2024-YL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: (1) to evaluate the feasibility of innovative school-based interventions on health outcomes (psychological well-being, depressive symptoms, anxiety symptoms, physical activity, sleep duration, and sleep quality) among primary students in the post-COVID-19 pandemic period; (2) to explore children's experience of intervention; (3) to evaluate the effects of innovative school-based (WeJoy + WeHop) on depressive symptoms, physical activities, and sleep quality among primary 3 to 5 school children. Method: Two phases of the study will be conducted, including feasibility pilot study and main study. In phase 1, a sample of 40 school children will be recruited from two community centers for feasibility test and semi-structured individual face-to-face interview. In phase 2, a total of 408 school children will be recruited from primary schools in Hong Kong. This study will adopt a 2 two-group pre and post-design. Participants are randomly assigned equally into 1 intervention group (WeJoy+WeHop) and 1 control group (Routine Extra curriculum Activity). Participants will be assessed at baseline and post-intervention. The outcomes are depressive symptoms, physical activities, and sleep quality, using the Chinese version of the Center for Epidemiologic Studies Depression Scale for Children (CES-DC), the Chinese Version of the International Physical Activity Questionnaire (IPAQ-C), and the Chinese version of the Pittsburgh Sleep Quality Index (PSQI-C). Data analysis: Descriptive and inferential statistics will be performed to examine the research objectives.

Conditions

Childhood Obesity; Sleep Problems; Physical Activity

Keywords

Innovative school-based intervention; School children; Cognitive behavioral therapy; Exergaming

Outcome Measures

Primary Outcomes (1)

• Psychological outcome: Depressive symptoms

  Depressive symptoms will be assessed by the Chinese version of 20-item Center for Epidemiologic Studies Depression Scale for Children, CES-DC

  baseline, pre-intervention and immediately after the intervention

Secondary Outcomes (2)

• Physical activity

  baseline, pre-intervention and immediately after the intervention

• Sleep outcomes include subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction

  baseline, pre-intervention and immediately after the intervention

Study Arms (2)

School-based Cognitive Behavior Therapy (WeJoy and exergaming on the interactive floor (WeHop)

EXPERIMENTAL

School-based CBT (WeJoy) allows children to recognize, change, and partake in pleasant activities based on the CBT model. The WeJoy comprises six weekly sessions on psychoeducation, cognitive restructuring, behavioural activation, emotional regulation, and self-monitoring. Exergaming on the interactive floor (WeHop) using a portable interactive projector games system. Each session provides 2 to 3 games per week for six weeks.

Behavioral: WeJoy+WeHop

Usual class

NO INTERVENTION

Usual extra curriculum activities that are arranged by corresponding primary schools

Interventions

WeJoy+WeHop BEHAVIORAL

School-based CBT (WeJoy) comprises six weekly sessions on psychoeducation, cognitive restructuring, behavioural activation, emotional regulation, and self-monitoring. Exergaming on the interactive floor (WeHop) can gain a sense of autonomy, competence, and relatedness to help them regulate their emotions and maintain positive behaviours according to the Self-Determination Theory. Children participate in the interactive floor games by stepping on various targets and moving in response to the game's rules. Combining task division, cooperation, and taking turns constitutes the collaboration mechanism.

School-based Cognitive Behavior Therapy (WeJoy and exergaming on the interactive floor (WeHop)

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Primary students ranged from primary 3 to 5 school children.
• Obtained consent forms from their legal guardians.

You may not qualify if:

• Primary students in primary 1 due to the adaptation of the new environment.
• Primary 6 due to the preparation of the examinations for secondary schools.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Pediatric Obesity; Parasomnias; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 1:1

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 9, 2025
• Study Start: February 23, 2024
• Primary Completion: June 19, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

HK (1)