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临床试验/NCT07133542
NCT07133542已完成不适用

The 9-Box Performance Management Framework: Impacts on Body Weight Regulation and Exercise Behaviors in Graduate Students

Hainan Normal University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年4月20日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Change in Waist-to-Hip Ratio (WHR)

研究概览

简要总结

The goal of this randomized controlled trial is to test whether a dual-dimensional 9-grid matrix intervention improves body composition and exercise adherence compared to standard aerobic exercise in overweight/obese college students. The main questions it aims to answer are:

Does the 9-grid model optimize fat distribution (measured by waist-hip ratio) and sustain body fat reduction better than traditional exercise?

Does dynamic risk stratification in the 9-grid system enhance long-term exercise adherence?

How does spatial migration of participants within the grid (quantified by centroid index G) reflect intervention efficacy?

Researchers will compare the 9-grid management group (receiving dynamic positioning + 5-tier personalized strategies) to the control group (receiving standardized aerobic exercise) to see if the 9-grid model:

Reduces waist-hip ratio more effectively

Delays intervention plateau in body fat loss

Increases exercise adherence at 8 weeks

Participants will:

Undergo body measurements (weight, body mass index (BMI), body fat percentage, waist/hip circumference) at baseline, 4 weeks, and 8 weeks

Complete the Exercise Adherence Rating Scale (EARS) at 4 and 8 weeks

If in 9-grid group:

  • Be classified into 1 of 9 grid zones every 2 weeks based on waist circumference risk + body fat status
  • Receive zone-specific interventions (nutrition/exercise/behavioral guidance)

If in control group:

  • Perform progressive aerobic exercise (40-90% heart rate reserve (HR) 3×/week
  • Use heart rate monitors for intensity tracking

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 36 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age & Status:
  • Full-time university students aged 18-36 years
  • Overweight/Obesity Diagnosis (per Chinese criteria):
  • Males: Body Mass Index (BMI) ≥24 kg/m² AND waist circumference ≥85 cm
  • Females: Body Mass Index (BMI) ≥24 kg/m² AND waist circumference ≥80 cm
  • Exercise Capacity:
  • Able to safely perform moderate-intensity exercise (confirmed by Physical Activity Readiness Questionnaire [PAR-Q], all items "No")
  • Tech Compliance:
  • Own smartphone with proficiency in health apps (e.g., WeChat Sport)
  • Informed Consent:
  • Signed written consent with commitment to complete 12-week intervention

排除标准

  • Metabolic Diseases:
  • Diagnosed diabetes, thyroid dysfunction, or history of cardiovascular disease
  • Exercise Contraindications:
  • Orthopedic/neurological conditions limiting exercise
  • Confounding Medications:
  • Use of weight/metabolism-affecting drugs in past 3 months
  • Special Physiological Status:
  • Pregnancy or lactation
  • Conflicting Participation:
  • Concurrent enrollment in other weight-management trials

结局指标

主要结局

Change in Waist-to-Hip Ratio (WHR)

时间窗: Baseline, Week 4, Week 8

Body Mass Index (BMI)

时间窗: Baseline, Week 8

Adherence to exercise

时间窗: Week 4, Week 8

Exercise adherence will be assessed using the standardized Exercise Adherence Rating Scale (EARS). This validated, self-reported questionnaire comprises 16 items. The first 6 items directly assess participants' behavioral adherence to the prescribed exercise regimen (e.g., session attendance, duration). The subsequent 10 items evaluate reasons for adherence or non-adherence, capturing key cognitive dimensions such as perceived barriers and motivation. All items are rated on a 5-point Likert scale ranging from "Completely Agree" (scored as 0) to "Completely Disagree" (scored as 4). Total scores are calculated such that higher scores indicate better exercise adherence.

Body Fat Percentage

时间窗: Baseline, Week 4, Week 8

Body Fat Percentage

时间窗: Baseline, Week 4, Week 8

Change in Waist-to-Hip Ratio (WHR)

时间窗: Baseline, Week 4, Week 8

Body Mass Index (BMI)

时间窗: Baseline, Week 8

Adherence to exercise

时间窗: Week 4, Week 8

Exercise adherence will be assessed using the standardized Exercise Adherence Rating Scale (EARS). This validated, self-reported questionnaire comprises 16 items. The first 6 items directly assess participants' behavioral adherence to the prescribed exercise regimen (e.g., session attendance, duration). The subsequent 10 items evaluate reasons for adherence or non-adherence, capturing key cognitive dimensions such as perceived barriers and motivation. All items are rated on a 5-point Likert scale ranging from "Completely Agree" (scored as 0) to "Completely Disagree" (scored as 4). Total scores are calculated such that higher scores indicate better exercise adherence.

次要结局

未报告次要终点

研究者

发起方
Hainan Normal University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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