NCT06642064

Brief Summary

A randomized controlled trial (RCT) was conducted to evaluate the changes in physical activity in adolescents before and after a health education program intervention based on the PRECEDE-PROCEED model.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 5, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

October 8, 2024

Last Update Submit

October 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Health education based on the PRECEDE-PROCEED model has a positive impact on promoting physical activity among adolescents in Yunnan Province

    This study collected data via questionnaires, physical fitness tests, and vision assessments. Instruments included validated questionnaires-ASAFA-C, Q-SPACE-C, EBBS-CN, PAQ-CN, and S-PASESC-measuring social support, school environment, perceived benefits/barriers, activity levels, and self-efficacy. Physical tests per NSPFH 2014 included BMI, sprints, runs, jumps, pull-ups/sit-ups, and vital capacity. Data were analyzed using descriptive statistics and repeated measures ANOVA/MANOVA over four measurements.

    12 weeks

Study Arms (2)

Intervention group and Control group (2 groups)

EXPERIMENTAL

This study held a group meeting before the formal experiment to guide all participants in advance and explain the entire experimental process to them in detail. Students with questions were given a unified and detailed explanation. Each participant received a health education manual and a physical activity record book. During the experimental stage, the researchers reminded the participants to attend the health education lectures and physical activity experiments on time. Participants were required to participate in the experiment according to the experimental content.

Behavioral: Intervention group

control group

NO INTERVENTION

Control group: Participants only received a logbook to record their physical activity every week and participated in regular physical exercise activities at school

Interventions

• Intervention group: Participants were invited to participate in a 20-minute interactive learning course (PPT lecture) and a 25-minute physical activity.The intervention lasted for 12 weeks, twice a week, 45 minutes each time, for a total of 1080 minutes.

Intervention group and Control group (2 groups)

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 18 years old, resident in Kunming, Yunnan, China;
  • Adolescents who are understand the information that explained by the researcher and agree to be included in the study;
  • Voluntarily participate in the experiment, cooperate with the research during the research process, and sign the informed consent;
  • Adolescents who healthy to participate in physical activity (measured by PAR-Q).

You may not qualify if:

  • Mental illness with cognitive impairment;
  • People with speech or ear dysfunction;
  • Recent or upcoming surgery (within 3 months), or commonalities;
  • Subjects During the research period, if symptoms of discomfort occur, they are asked to stop and withdraw according to the subject\'s own will;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anning No. 1 Middle School in KunMing,Yunnan Province, China

Kunming, Yunnan, 650500, China

Location

Study Officials

  • Linxian Zeng, PHD

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Intervention group and Control group (2 groups): • Intervention group: Participants were invited to participate in a 20-minute interactive learning course (PPT lecture) and a 25-minute physical activity.The intervention lasted for 12 weeks, twice a week, 45 minutes each time, for a total of 1080 minutes. • Control group: Participants only received a logbook to record their physical activity every week and participated in regular physical exercise activities at school.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 15, 2024

Study Start

September 5, 2023

Primary Completion

December 22, 2023

Study Completion

December 30, 2023

Last Updated

October 15, 2024

Record last verified: 2023-08

Locations