NCT07136818

Brief Summary

This study aims to develop and validate an innovative dynamic 9-square grid management model to improve aerobic capacity (AC) and physical activity participation among graduate students. The model integrates real-time exercise volume (quantified via smart wearable devices) and aerobic capacity (assessed by 12-minute run tests) into a two-dimensional grid, stratifying participants into five tiers for differentiated interventions. Using a 2 × 3 mixed-design (feedback frequency: weekly vs. monthly; time points: baseline/mid/post-intervention), 32 healthy graduate students are randomized into two groups: Weekly feedback (dynamic position updates + tailored optimization strategies). Monthly feedback (position updates at monthly intervals). Key components include: Multimodal assessment: Objective exercise metrics (Huawei Band 6), AC (12-min run), psychological scales (Exercise Identity Scale, Self-Efficacy for Exercise Scale). Tiered intervention: Customized strategies based on grid positioning (e.g., "Star Talent" optimization vs. "Urgent Attention" support). Primary outcomes: Changes in AC, total exercise volume (TEV), exercise identity, and self-efficacy. The study seeks to determine whether weekly dynamic feedback outperforms monthly feedback in sustaining behavioral change and enhancing physiological adaptation. Ethical approval was obtained from Anqing Normal University (AQNU2024110).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

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

October 14, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

August 8, 2025

Last Update Submit

August 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Aerobic Capacity (12-min run distance)

    Description: Distance run in meters during standardized 12-minute field test. Measurement Tool: GPS-tracked outdoor run (Keep App + Huawei Band 6).

    Baseline, Week 5 (mid-intervention), Week 9 (post-intervention).

Secondary Outcomes (1)

  • Exercise Self-Efficacy (SEE-C Scale)

    Timeframe: Baseline and Week 9.

Study Arms (2)

Weekly Feedback Group

EXPERIMENTAL

Dynamic placement in a 9-grid matrix (based on aerobic capacity + total exercise volume) updated weekly.

Behavioral: Dynamic 9-Square Grid Health Management with Weekly Feedback

Monthly Feedback Group

PLACEBO COMPARATOR

Comparison group testing low-frequency feedback.

Behavioral: Dynamic 9-Square Grid Health Management with Monthly Feedback

Interventions

A dual-axis management system categorizing participants into a 3x3 grid based on aerobic capacity (12-min run test) and total exercise volume (smart-device tracked). Includes weekly personalized feedback, tiered exercise prescriptions, and goal recalibration. Arm 1 receives updates every 7 days.

Weekly Feedback Group

Identical grid framework as Arm 1 (aerobic capacity + exercise volume assessment), but with monthly (30-day) feedback cycles. Participants receive delayed optimization strategies and tier adjustments once per calendar month, simulating conventional health programs."

Monthly Feedback Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Graduate students aged between 18 and 30 years.
  • Completion of the Physical Activity Readiness Questionnaire (PAR-Q) to confirm readiness for exercise.
  • Completion of a sociodemographic questionnaire (including age, gender, and education level).
  • Confirmation of absence of exercise contraindications (e.g., conditions that may prevent safe participation in physical activity).
  • Confirmation of absence of cardiovascular disease.
  • Confirmation of absence of recent lower-limb injuries (occurring within the past 3 months or less).
  • Confirmation of absence of chest pain symptoms.
  • Ability to provide written informed consent for voluntary participation.

You may not qualify if:

  • Presence of exercise contraindications identified through the PAR-Q or clinical evaluation.
  • History or diagnosis of cardiovascular disease (e.g., heart conditions, stroke, or related disorders).
  • Recent lower-limb injuries (e.g., fractures, sprains, or surgeries) within the past 3 months.
  • Experience of chest pain symptoms (e.g., angina or discomfort during physical exertion).
  • Inability to complete the required questionnaires or assessments due to cognitive or language barriers.
  • Presence of any uncontrolled chronic condition that could interfere with exercise participation, as determined by the researchers during screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hainan Normal University

Haikou, Hainan, 571158, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2025

First Posted

August 22, 2025

Study Start

October 14, 2024

Primary Completion

December 30, 2024

Study Completion

January 10, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Aerobic capacity test results;Smart wearable exercise data;Cloud-synced TEV metrics (intensity/duration/frequency);Aggregated weekly values;Psychological scales (EIS/SEE-C);Encrypted survey responses;Baseline demographics;Limited metadata (age/BMI)。

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
1 January 2030;
Access Criteria
Academic researchers affiliated with accredited institutions Regulatory bodies (e.g., ethics committees) Peer reviewers for journal publication validation Access Process: Step 1: Submit research proposal via OpenClinica Platform Step 2: Institutional ethics approval documentation required Step 3: Data Use Agreement (DUA) signing with corresponding authors
More information

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