Study on the Effectiveness of a School-Based Fat Loss Program for Adolescents

Study of the Effectiveness of an Exercise Intervention Oriented Toward Fat Loss in Adolescents

The students were divided into an intervention group and a control group. The intervention group attended fat loss exercise classes three times a week and the parents cooperated with us in dietary monitoring and control. Before and after the intervention, questionnaires were completed, physical fitness and body composition were measured, and physical activity measurement bracelets were worn for 4 days. In this study, it is possible to know the mental health state, physical activity habits, body composition and physical fitness of adolescents.

Study Overview

• Status: Completed
• Conditions: Prevention
• Intervention / Treatment: Behavioral: Exercise and dietary calorie restriction

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Weifang, Shandong, China, 261000
      • Aiyoudong Children and Youth Sports Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Passed PAR-Q questionnaire screening
• No professional sports experience
• Able to understand the test
• Voluntarily participate in the entire testing process

Exclusion Criteria:

• Serious organic pathology of the heart, brain, lungs, kidneys, and locomotor system
• Taking medication for a chronic condition
• Have history of psychiatric disorders
• Inability to complete follow-up visits or poor adherence.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise and dietary calorie restriction intervention group; Received a twelve-week comprehensive intervention. The number of participants is 50.	Behavioral: Exercise and dietary calorie restriction; The intervention group received an exercise intervention three times a week (resistance exercise from 4:30-5:00 p.m. and aerobic exercise from 5:00-5:30 p.m.), and a caloric restriction intervention (guided semi-libre diet with caloric intake restricted to 75% of overall consumption, with parents keeping track of calories and food groups and receiving regular check-ups)
No Intervention: control group; Normal school life without any intervention. The number of participants is 50.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body fat percentage (%)	Measured by Inbody, a body composition tester using bioelectrical impedance, in %.	From enrollment to the end of intervention at 12 weeks
Physical fitness	Measured using China National Standards for Students' Physical Health (2014 revision), with a minimum value of 0 and a maximum value of 100, higher scores respond to better fitness.	From enrollment to the end of intervention at 12 weeks
Physical activity	Physical activity (PA) was measured using Actigraph GT3X+ accelerometers, with data expressed as minutes per day (min/day).	From enrollment to the end of intervention at 12 weeks
Fat-free mass	Measured by Inbody, a body composition tester using bioelectrical impedance, in kg.	From enrollment to the end of intervention at 12 weeks
Fat mass	Measured by Inbody, a body composition tester using bioelectrical impedance, in kg.	From enrollment to the end of intervention at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary testosterone	Salivary testosterone levels were measured using radioimmunoassay (RIA) and expressed in picograms per liter (pg/L).	From enrollment to the end of intervention at 12 weeks
Resilience	Connor-Davidson Resilience Scale-10 (CD-RISC-10). The scale consists of 10 items, each of which has a score range of 0-4, and the total score range of the scale is 0-40, with higher scores representing greater resilience.	From enrollment to the end of intervention at 12 weeks
Self-esteem	The Rosenberg Self-Esteem Scale was used, with a total of 10 items. Scores on the scale range from 10 to 40, with higher scores indicating higher levels of self-esteem and better outcomes.	From enrollment to the end of intervention at 12 weeks
Aggression	Assessed using the Buss-Perry Aggression Questionnaire with a total score range of 29-145. The higher the score, the more aggressive the individual is in that area and the worse the outcome.	From enrollment to the end of intervention at 12 weeks
Eating Self-efficacy	Eating Self-Efficacy Scale . The minimum score is 10 and the maximum score is 100. Higher scores indicate greater self-efficacy in eating and better outcomes.	From enrollment to the end of intervention at 12 weeks
Exercise Self-Efficacy	Exercise Self-Efficacy Scale . The minimum score is 18 and the maximum score is 180. The higher the score, the stronger the self-efficacy in exercise and the better the result.	From enrollment to the end of intervention at 12 weeks

Collaborators and Investigators

• Sponsor: Aiyoudong Children and Youth Sports Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2022
• Primary Completion (Actual): December 10, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Basic-2334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No