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Overweight and/or ObesityNCT07133542

Multicomponent Weight Management Versus Structured Aerobic Exercise in Postgraduate Students

A study testing Standard Aerobic Prescription in people with Overweight and/or Obesity, run by Hainan Normal University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This single-center, two-arm, parallel exploratory randomized controlled trial compared multicomponent weight management incorporating a 3×3 waist circumference-body fat percentage (WC-BFP) phenotype classification with structured aerobic exercise over 8 weeks. Read more about this study

Who is it for?
Ages 18 to 36 years
Conditions the study is for
Overweight and/or Obesity
What is being tested?
Standard Aerobic Prescription
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
20 Apr 2025to 9 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 36 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age \& Status:Full-time postgraduate students aged 18-36 years.
  • Excess-Adiposity Criteria:
  • Meeting at least one of the following criteria:
  • Overweight or obesity (BMI > 24 kg/m2);
  • Central obesity (WC > 85 cm in men or > 80 cm in women);High BFP (> 20% in men or > 25% in women).
  • Exercise Capacity: Able to safely perform moderate-intensity exercise (confirmed by PhysicalActivity Readiness Questionnaire [PAR-Q], all items "No").
  • Tech Compliance: Own smartphone with proficiency in health apps (e.g., WeChat Sport).
  • Informed Consent: Signed written informed consent before study participation.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Hainan Normal University

    Haikou, Hainan

Other trials in China

About this study

Official title: Adaptive Weight Management Guided by a 3×3 WC-BFP Phenotype in Postgraduate Students With Overweight or Obesity: An Exploratory Randomized Controlled Trial

This single-center, two-arm, parallel exploratory randomized controlled trial compared multicomponent weight management incorporating a 3×3 waist circumference-body fat percentage (WC-BFP) phenotype classification with structured aerobic exercise over 8 weeks. Forty-eight postgraduate students with overweight, central obesity, or elevated BFP were randomized 1:1. The adaptive intervention combined aerobic, resistance, and flexibility exercise with individualized nutritional and behavioral support; WC and BFP were reassessed every 2 weeks to guide prescription adjustments. The comparator involved 3-5 aerobic exercise sessions per week, with a prescribed weekly aerobic-duration target exceeding 150 minutes per week, with progressive intensity from 40%-50% to 60%-80% of heart rate reserve. Both groups received individualized daily energy-intake targets intended to create an energy deficit, wearable monitoring, online exercise and dietary logging, and remote supervision. Anthropometric outcomes and exercise self-efficacy were assessed at baseline and weeks 4 and 8; exercise adherence was assessed at weeks 4 and 8.

The trial evaluated the intervention packages as a whole and did not isolate the independent contribution of WC-BFP classification. The manuscript emphasizes week-8 body weight, with additional anthropometric, behavioral, and exploratory classification outcomes. The trial was retrospectively registered; subsequent record updates do not establish prospective specification of the outcome hierarchy.

Read the detailed description

Study design and participants This single-centre, two-arm, parallel exploratory randomized trial was conducted at Hainan Normal University, China. Forty-eight postgraduate students were randomized in a 1:1 ratio. Participants met at least one of the following excess-adiposity criteria: BMI of at least 24 kg/m²; WC of at least 85 cm in men or 80 cm in women; or BFP of at least 20% in men or 25% in women. The intervention period reported in the manuscript was eight weeks.

Multicomponent intervention The intervention combined aerobic, resistance, and flexibility exercise with individualized nutritional and behavioural support. WC and BFP were cross-classified into nine categories.

WC categories were below 85, 85 to below 90, and at least 90 cm in men, and below 80, 80 to below 85, and at least 85 cm in women. BFP categories were below 20%, 20% to below 25%, and at least 25% in men, and below 25%, 25% to below 30%, and at least 30% in women.

At two-week reassessments, WC and BFP were reclassified jointly using the same sex-specific cutoffs. Participants whose measurements placed them in a different cell were assigned the prescription associated with that cell. When the two measures changed in opposite directions, the newly observed cross-classification determined the cell assignment. Reassessment within the same cell did not itself constitute a category change. These categories organized the intervention; their independent clinical utility was not tested by this randomized comparison.

Active comparator The comparator was an eight-week structured aerobic exercise programme, primarily involving brisk walking, jogging, or cycling. The programme prescribed 3-5 sessions per week and a weekly aerobic-duration target exceeding 150 minutes. Sessions included a 5-minute warm-up, 25-40 minutes of core aerobic exercise, and a 15-minute cool-down.

Core intensity was prescribed at 40%-50% of heart rate reserve during weeks 1-2, 50%-70% during weeks 3-6, and 60%-80% during weeks 7-8. Exercise load could be adjusted for fatigue or reduced tolerance. The comparator did not use WC-BFP categories to assign management tiers or guide prescription changes.

Shared support and monitoring Both groups received individualized daily energy-intake targets intended to create an energy deficit according to individual circumstances, Huawei Band 9 monitoring, daily online exercise and dietary logging, and remote supervision. Dietary records were submitted for staff review. Prescribed dietary and exercise targets were distinguished from achieved intake and exercise exposure.

Outcome assessments Body weight and BFP were measured using a bioelectrical impedance device. BMI was calculated as weight in kilograms divided by height in metres squared. WC and hip circumference were measured using a standardized anthropometric procedure, and waist-to-hip ratio was calculated as WC divided by hip circumference.

Exercise self-efficacy was assessed using the Chinese version of the Self-Efficacy for Exercise Scale. Self-reported adherence was assessed using Section B of the Exercise Adherence Rating Scale. Anthropometric outcomes and self-efficacy were assessed at baseline and weeks 4 and 8; adherence was assessed at weeks 4 and 8, without a baseline adherence assessment.

Analysis of observed outcomes The observed-outcome analyses used mixed models for repeated measures and included all valid follow-up measurements under the original randomized assignment. Anthropometric outcomes and exercise self-efficacy were adjusted for their respective baseline values. No baseline adherence covariate was included because adherence was not assessed at baseline. Valid scheduled measurements obtained after discontinuation of the intervention were retained. Intervention discontinuation and availability of outcome measurements were treated as separate statuses.

The eight week-8 between-group comparisons comprised body weight, BMI, BFP, WC, hip circumference, waist-to-hip ratio, exercise self-efficacy, and self-reported exercise adherence. Holm adjustment was applied across this family of eight comparisons. Effect estimates were reported with nominal 95% confidence intervals.

Missing-data and covariate sensitivity analyses Missing-data sensitivity analyses retained the 48-participant randomized framework. Under a missing-at-random assumption, multiple imputation used 50 completed datasets and 20 fully conditional specification iterations. Direct anthropometric measurements used normal linear regression imputation, and questionnaire scores used predictive mean matching. Predictors included randomized group, sex, the applicable baseline measurement, and the other follow-up measurement. WC, hip circumference, and missing waist-to-hip ratio values used the same jointly completed WC and hip-circumference components. Observed measurements were retained without replacement.

Additional analyses examined departures from the missing-at-random assumption for body weight, adjustment for sex across all eight week-8 outcomes, and additional adjustment for baseline BFP in the body-weight analysis. These analyses were conducted during manuscript revision and should not be interpreted as prospectively registered analyses.

Interpretation of the comparison The randomized contrast compared an integrated intervention package with an active aerobic comparator under shared dietary-target and digital-monitoring conditions. The packages differed in exercise modalities and individualized management components. The trial therefore cannot attribute any between-group difference specifically to phenotype matching or separate its contribution from exercise dose, nutrition, behavioural support, or professional contact.

Registration and outcome specification The record was first submitted to ClinicalTrials.gov on August 10, 2025 and first posted on August 21, 2025, after the currently recorded study completion date. Registration was retrospective. The current registration lists BMI and body weight as primary outcomes, whereas the manuscript emphasizes week-8 body weight. Subsequent registry corrections and analyses conducted during manuscript revision do not establish prospective specification of the outcome hierarchy.

Being tested
Dynamic Matrix Management for Weight Control (DMM-WC), Standard Aerobic Prescription
Keywords
weight management, waist circumference, body fat percentage, Postgraduate students, Aerobic exercise

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic Matrix Management for Weight Control (DMM-WC)Behavioural

    An 8-week multicomponent weight-management program combining aerobic, resistance, and flexibility exercise with individualized nutritional and behavioral support. Sex-specific WC and BFP categories were cross-classified into nine cells to organize prescriptions. WC and BFP were reassessed every 2 weeks, and a change in cell assignment informed reassignment to the corresponding prescription. Both groups received dietary intake targets, wearable monitoring, online exercise and dietary logging, and remote supervision. The independent effect of the WC-BFP classification was not isolated by this comparison.

  • Standard Aerobic PrescriptionBehavioural

    An 8-week structured aerobic exercise program involving brisk walking, jogging, or cycling, prescribed for 3-5 sessions per week with a weekly aerobic-duration target exceeding 150 minutes. Core exercise intensity progressed from 40%-50% of heart rate reserve during weeks 1-2 to 50%-70% during weeks 3-6 and 60%-80% during weeks 7-8. Exercise load could be adjusted for fatigue or reduced tolerance. Participants received shared dietary-target, wearable-monitoring, online-logging, and remote-supervision procedures. WC-BFP categories were not used to assign management tiers or guide prescription changes.

Study groups in NCT07133542
Study groupRoleWhat they receive
Dynamic Nine-Grid Matrix GroupExperimentalParticipants received adaptive multicomponent management incorporating a 3×3 WC-BFP phenotype classification linked to five management tiers. Prescriptions included aerobic, resistance, and flexibility exercise, together with individualized nutritional and behavioral support. WC and BFP were reassessed every 2 weeks, and participants moving to a different cell were assigned the prescription associated with their updated WC-BFP combination. Discordant changes in WC and BFP were handled using the newly observed cross-classification. Both groups received individualized daily energy-intake targets intended to create an energy deficit, wearable monitoring, daily online exercise and dietary logging, and remote supervision. The intervention lasted 8 weeks and was evaluated as a complete package.
Receives: Behavioral: Dynamic Matrix Management for Weight Control (DMM-WC)
Standard Aerobic Prescription GroupActive comparatorParticipants followed an 8-week structured aerobic exercise program consisting of 3-5 sessions per week, with a prescribed weekly aerobic-duration target exceeding 150 minutes per week, primarily through brisk walking, jogging, or cycling. Each session included a 5-minute warm-up, 25-40 minutes of core aerobic exercise, and a 15-minute cool-down. Prescribed intensity was 40%-50% of heart rate reserve during weeks 1-2, 50%-70% during weeks 3-6, and 60%-80% during weeks 7-8. Both groups received individualized daily energy-intake targets intended to create an energy deficit, Huawei Band 9 monitoring, online exercise and dietary logging, and remote supervision. Training load could be reduced within the prescribed intensity ranges for marked fatigue or reduced exercise tolerance. The comparator did not receive WC-BFP phenotype-guided tiering or prescription adjustments.
Receives: Behavioral: Standard Aerobic Prescription

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BODY WEIGHT

    Body weight in kilograms, measured using the MJTZC01YM bioelectrical impedance device (Xiaomi, China). Week-8 body weight is the endpoint described by this measure. Baseline and week-4 measurements were also collected. The between-group comparison accounts for baseline body weight.

    Measured: Week 8; additional measurements at baseline and week 4

  2. BODY MASS INDEX

    Body mass index in kg/m², calculated as body weight in kilograms divided by height in metres squared. Week-8 BMI is the endpoint described by this measure. Baseline and week-4 measurements were also collected.

    Measured: Week 8; additional measurements at baseline and week 4

Secondary outcomes (4)
  1. WAIST CIRCUMFERENCE

    Waist circumference in centimetres, measured at the midpoint between the lowest rib and the iliac crest at the end of normal expiration. Week-8 waist circumference is the endpoint described by this measure. Baseline and week-4 measurements were also collected.

    Measured: Baseline, week 4, and week 8; the secondary endpoint comparison is at week 8.

  2. BODY FAT PERCENTAGE

    Body fat percentage, expressed as the percentage of body weight estimated to be fat by the MJTZC01YM bioelectrical impedance device (Xiaomi, China). Week-8 BFP is the endpoint described by this measure. Baseline and week-4 measurements were also collected. Between-group differences in BFP are expressed in percentage points.

    Measured: Baseline, week 4, and week 8; the secondary endpoint comparison is at week 8.

  3. HIP CIRCUMFERENCE

    Hip circumference in centimetres, measured at the widest part of the buttocks. Week-8 hip circumference is the endpoint described by this measure. Baseline and week-4 measurements were also collected.

    Measured: Baseline, week 4, and week 8; the secondary endpoint comparison is at week 8.

  4. WAIST-TO-HIP RATIO

    Waist-to-hip ratio, calculated as waist circumference divided by hip circumference using measurements in the same units. The ratio is dimensionless. Week-8 WHR is the endpoint described by this measure. Baseline and week-4 measurements were also collected.

    Measured: Baseline, week 4, and week 8; the secondary endpoint comparison is at week 8.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2025
  2. Study start20 Apr 2025
  3. Primary completion30 Jun 2025
  4. Study completion9 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07133542
Sponsor's protocol ID
AQNU2024111
Status last verified
Aug 2025
First submitted
10 Aug 2025
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data to be shared include the anthropometric measurements collected at baseline and weeks 4 and 8; SEE-C item responses or scores collected at baseline and weeks 4 and 8; EARS item responses or scores collected at weeks 4 and 8; and the WC-BFP categories and baseline-to-week-8 transitions derived from the observed anthropometric measurements. No baseline EARS assessment was performed.

Questions about this trial

What is this clinical trial studying?

A study testing Standard Aerobic Prescription in people with Overweight and/or Obesity, run by Hainan Normal University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BODY WEIGHT (time frame: Week 8; additional measurements at baseline and week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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