A Waist Circumference and Body Fat Percentage Dual-Dimension Nine-Square Grid Model for Precision Obesity Management: A Randomized Controlled Trial in Overweight/Obese University Students

NCT07133542 | Completed DMC

• 1 other identifier: AQNU2024111
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overweight and/or Obesity

Outcome Measures

Primary Outcomes (4)

• Change in Waist-to-Hip Ratio (WHR)

  Baseline, Week 4, Week 8

• Body Mass Index (BMI)

  Baseline, Week 8

• Adherence to exercise

  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.

  Week 4, Week 8

• Body Fat Percentage

  Baseline, Week 4, Week 8

Study Arms (2)

Dynamic Nine-Grid Matrix Group

EXPERIMENTAL

Tiered management via waist-risk/body-fat matrix. Participants receive bi-weekly health positioning and one of five precision strategies (e.g., high-intensity exercise + dietary control for Grid-I; low-intensity maintenance for Grid-IX). Real-time feedback via digital dashboard.

Behavioral: Dynamic Matrix Management for Weight Control (DMM-WC)

Standard Aerobic Prescription Group

PLACEBO COMPARATOR

Standardized progressive aerobic exercise at 40-90% heart rate reserve. Intensity/volume are personalized at baseline but remain static afterward. Adherence monitored using Huawei wearables (no dynamic adjustments or tiered feedback).

Behavioral: Standard Aerobic Prescription

Interventions

Dynamic Matrix Management for Weight Control (DMM-WC) BEHAVIORAL

Precision weight management using a two-dimensional grid model. Participants undergo bi-weekly positioning on a waist risk-body fat matrix (9 grids), receiving tiered interventions (e.g., high-intensity exercise + dietary control for high-risk grids; maintenance plans for low-risk grids). Real-time progress feedback via visual spatial migration maps promotes adherence. Comparator group receives standardized aerobic prescription without dynamic adjustments.

Dynamic Nine-Grid Matrix Group

Standard Aerobic Prescription BEHAVIORAL

Personalized progressive aerobic exercise program. Participants receive baseline-adjusted intensity prescriptions (40-90% heart rate reserve), with adherence monitored via wearable devices. NO dynamic adjustments, tiered strategies, or visual feedback are provided throughout the 8-week intervention.

Standard Aerobic Prescription Group

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hainan Normal University: lead

Study Sites (1)

Hainan Normal University

Haikou, Hainan, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 21, 2025
• Study Start: April 20, 2025
• Primary Completion: June 30, 2025
• Study Completion: August 9, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 January 2030
• Access Criteria: Academic researchers affiliated with accredited institutionsRegulatory bodies Peer reviewers for journal publication validationAccess Process:Step 1: Submit research proposal via OpenClinica PlatformStep 2: Institutional ethics approval documentation requiredStep 3: Data Use Agreement signing with corresponding authors

Locations

CN (1)